Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401850967550 Date of Registration: 24/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults.
Official scientific title A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults.
Brief summary describing the background and objectives of the trial The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA- Negative Cohort and Human Immunodeficiency virus (HIV) Cohort. The trial will include 2 groups (M72/AS01E-4 group and placebo group). Participants will receive 2 doses of either M72/AS01E-4 or placebo based on randomization, administered intramuscularly (IM) approximately one month apart. This current trial is designed a) to confirm the results of the Phase 2b trial and b) to describe safety, immunogenicity, and vaccine efficacy (VE) in people living with HIV (PLHIV) and in an IGRA (Interferon gamma release assay) - negative, HIV (human immunodeficiency virus) -negative population. Specifically, the primary objective of the trial is to demonstrate VE for the prevention of laboratory-confirmed pulmonary TB in IGRA-positive participants without HIV infection, and secondary objectives include safety, reactogenicity, immunogenicity, and descriptive VE in IGRA-negative participants and in participants with well-controlled HIV infection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/02/2024
Actual trial start date 05/03/2024
Anticipated date of last follow up 30/04/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 20000
Actual target sample size (number of participants) 20081
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mycobacteriumtuberculosis investigationalvaccine A 0.5 mL dose ofM72/AS01E-4 - 10μgM72, reconstituted withAS01E-4, aGlaxoSmithKline(GSK) proprietaryadjuvant systemcontaining 25 μg MPL(3-O-desacyl-4-monophosphoryl lipidA, produced by GSK),and 25 μg QS-21(Quillaja saponariaMolina, fraction 21). 2 doses of M72/AS01E-4- 1 month apart Active group 10041
Control Group Placebo 0.5 mL normal saline -0.9% NaCl 2 doses of placebo - 1month apart Placebo group 10040 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Participant must be 15 to 44years of age (inclusive), at the time of signing the consent or assent. 2. Capable of giving informed consent or informed assent (as appropriate). For participants below the age of consent, the participant’s parent,or legally authorized representative(LAR) will be required to sign a statement of informed consent, in addition to the minor’s signed statement of assent. 3. In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of diary cards as applicable, and returnfor follow-up visits). 4. Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety. 5. Agree to provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial. 6. Healthy, or with preexisting stable disease, as established by medical history and physical examination and as determined by the investigator. Pre existing stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrollment. 7.Negative sputum Xpert Ultra or similar assay result at screening (this criterion can be waived if participant is unable to produce sufficient sputum) 8. Both males and females are included.Females are included with restrictions. 9.HIV-negative test result at screening (IGRA-Positive Cohort and IGRA-Negative Cohort only) 10. HIV Cohort only: Participants with documented HIV infection who fulfill all of the following criteria: •have reactive anti-HIV antibody at screening • have been on ARTfor at least 3 consecutive months at screening and agree to remain on ART throughout the trial •have documented HIV RNA <200copies/mL at screening • haveCD4+ cell count ≥200 cells/μL at screening • have had TPT in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators • have an IGRA 1. Current TB, or history of TB or treatment for TB disease 2.Clinical suspicion of pulmonary TB at screening, defined as a participant presenting with one or more of the following signs or symptoms: unexplained cough, unexplained fever, night sweats, unintentional weight loss, hemoptysis, pleuritic chest pain 3. Any current medical, psychiatric, occupational, or substance abuse problems 4.Any confirmed or suspectedimmunosuppressive orimmunodeficient conditionresulting from disease (e.g.,invasive, or malignant cancers),other than HIV infection in theHIV Cohort 5. Any cytotoxicdrugs or administration ofmedications known to have amajor impact on the immunesystem, as determined by theinvestigator, within 90 days priorto Day 1. 6. Planned receipt ofblood, or blood products duringthe trial period 7. Receipt orplanned receipt of any vaccine inthe period starting 28 daysbefore, and ending 28 days after,each dose of the trial vaccine 8.History of previous administrationof an experimental Mtb vaccineincluding M72/AS01E in aprevious trial 9. History of allergy or hypersensitivity to the trialintervention, excipients, orrelated substances Diagnosticassessments 10. An indeterminate IGRA test result atscreening 11. Female participants with any one of thefollowing conditions: currentlypregnant or lactating 12. Only inthe HIV Cohort: Safety laboratory values at screening that are ofconcern, based on investigator’s judgment 13. Participation in aninterventional clinical trial inwhich the participant has been orwill be exposed to an investigational product(pharmaceutical product ordevice), within 28 days prior tosigning consent or assent, orduring the trial period. 14.Individuals who are acting aspersonnel for this trial, or whohave immediate family members who are acting as personnel forthis trial 15. Child in Care,defined as a child who is underthe care (control or protection) ofan agency or organization. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 15 Year(s) 44 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/09/2023 Pharma Ethics Pty Ltd
Ethics Committee Address
Street address City Postal code Country
Lyttelton Manor Centurion 0157 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/10/2023 SAMRC
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive, Parowvallei Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2023 UNZABREC
Ethics Committee Address
Street address City Postal code Country
Ridgeway campus Lusaka 0000 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/10/2023 KNH UoN ERC
Ethics Committee Address
Street address City Postal code Country
PO Box 19676 Nairobi 00202 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/10/2023 Wits Ethics
Ethics Committee Address
Street address City Postal code Country
Private bag X2600, Houghton Johannesburg 2041 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2023 Stellenbosch University HREC
Ethics Committee Address
Street address City Postal code Country
Francie van Zijl Drive, Tygerbery Campus Stellenbosch 7602 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/11/2023 Biomedical Research Ethics Commitee
Ethics Committee Address
Street address City Postal code Country
Private bag X54001 Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2023 MTRH MU Institutional Research and ethics Commitee
Ethics Committee Address
Street address City Postal code Country
PO Box 3 Eldoret 0000 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/09/2023 National Health Sciences Research Commitee
Ethics Committee Address
Street address City Postal code Country
PO Box 30377 Lilongwe 0000 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/12/2023 National Health Sciences Research Commitee
Ethics Committee Address
Street address City Postal code Country
Po Box 30377 Lilongwe 0000 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weightloss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding “trace positive”), from the same or from different sputum samples collected during the 3 suspected visits, preferably within a 7-day time frame, before initiation of TB treatment. Up to Month 49
Secondary Outcome IGRA-Negative Cohort: Number of participants with sustained QuantiFERON®-TB Gold Plus assay conversion Up to Month 49
Secondary Outcome IGRA-Negative Cohort: Number of participants with laboratory-confirmed pulmonary TB Up to month 49
Secondary Outcome HIV Cohort: Number of participants with laboratory-confirmed pulmonary TB Up to month 49
Secondary Outcome All Cohorts: Number of participants with solicited Adverse events (AEs) Up to 7 days
Secondary Outcome All Cohorts: Number of participants with unsolicited AEs Up to 28 days
Secondary Outcome All Cohorts: Number of participants with serious adverse events (SAEs) Up to month 13
Secondary Outcome All Cohorts: Number of participants with potential immunemediated diseases (pIMDs) Up to month 13
Secondary Outcome All Cohorts: Number of participants with SAEs related to study participation Up to month 49
Secondary Outcome All cohorts: Number of participants with Geometric mean concentration (GMC) of M72-specificantibodies At Day 1, Month 1, Month 2, Month 7, Month 13, Month37, and Month 49
Secondary Outcome All cohorts: Number of participants with seropositivity of M72-specific antibodies At Day 1, Month 1, Month 2, Month 7, Month 13, Month37, and Month 49
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UNC Poject Malawi Tidziwe Centre Mzimba Road, Kamuzu Central Hospital Lilongwe 00000 Malawi
Malawi Liverpool Wellcome Trust Research Programme Blantyre 3, P.O Box 30096 Chichiri 30096 Malawi
Centre for Family Health Research in Zambia Lusaka B22/F737 Mwembelelo, Centre for Family Health Research in Zambia, Emmasdale Post Net 412 P/BagE891 Lusaka 00000 Zambia
Centre for Family Health Research in Zambia Ndola 24 Lupili Road, PO Box 240262, Northrise Ndola 00000 Zambia
Zambart Ridgeway Campus, University of Zambia, Zambart Project Lusaka 50697 Zambia
CIDR Zambia Kalingalinga Research Site, Counting House Unit A TB Project, Thabo Mbeki Road, Lusaka 00000 Zambia
Homa Bay County Teaching and Referral Hospital Site P.O BOX 52 Homa Bay 00000 Kenya
Moi University Clinical Research Centre MUCRC Nandi Road, 2nd Floor, Chandaria Chronic Disease and Cancer Centre Moi Teaching and Referral Hospital Eldoret 30100 Kenya
KAVI Institute of Clinical Research College of Health Science, University of Nairobi, KNH Complex, Upper Hill, PO Box 19676 Nairobi 30100 Kenya
KEMRI Kericho Hospital Road, UN, Avenue, Nairobi, America Embassy, MRU Maj.Mike Baisa-Kericho CRC Laboratory Kericho 20200 Kenya
Victoria Biomedical Research Institute VIBRI Ring Road, Millimani Kisumu 40100 Kenya
Kenya Medical Research Institute Centre for Clinical Research PO Box 54840, off Raila Odinga Way Nairobi 00200 Kenya
Pwani Research Centre Ganjoni Dispensary, Mnazi Mmoja Road, BOX 91276 Mombasa 80103 Kenya
Clinical Research Health Network Along Makueni- Kitui Road, PO Box 19 Machakos 90100 Kenya
KEMRI Mtwapa Off Malindi Rd Mtwapa Kilifi 230-80108 Kenya
Be Part Research 4 Madikane Street Paarl 7626 South Africa
AHRI Somkhele CTU R618 to Hlabisa, Somkhele Mtubatuba 3935 South Africa
UCT Lung Institute George St, Mowbray Cape Town 7700 South Africa
MERCLINCO 184 Cowen Ntuli Middelburg 1050 South Africa
TASK Central 1 De Lange Street Cape Town 7530 South Africa
Ezintsha Research Centre 32 Princess of Wales Terrace Johannesburg 2193 South Africa
Desmond Tutu Health Foundation J52 Old Main Building, J floor, Groote SchuurHospital Cape Town 7925 South Africa
SAMRC Bothas Hill CRS 1 Zulu Reserve Road Durban 3610 South Africa
Soweto Clinical Trials Centre Sycamore Street Johannesburg 1818 South Africa
Qhakaza Mbokodo Research Clinic 15 Parklane, Mkhamba Gardens Ladysmith 3370 South Africa
Isango Lethemba TB Research Unit Mission Road Gqeberha 6059 South Africa
PHRU Matlosana 54 Benji-Olifant Road Jouberton 2574 South Africa
Wits Vaccines and Infectious DiseasesAnalytics Research Unit Chris Hani Road Soweto 2013 South Africa
Madibeng Centre for Research 40 Pienaar Str Brits 0250 South Africa
Aurum Institute OR Tambo and Margaretha Prinsloo Streets Klerksdorp 2570 South Africa
Perinatal HIV Research Unit Soweto New nurses residence, Chris HaniBaragwanath Hospital Soweto 1864 South Africa
The Aurum Institute Rustenburg ClinicalResearch Centre 178 Beyers Naude Drive Rustenburg 0299 South Africa
Wits RHI Shandukani Site 7 Esselen Street Johannesburg 2001 South Africa
GMGH research unit 157 12 Avenue Kensington Cape Town 7405 South Africa
CIDRI AFRICA Ekhayavac Research Unit corner Lwandile and Bonga Drive Khayelitsha 7935 South Africa
South African Vaccine Initiative Haarlem Drive Worcester 6850 South Africa
BioMedical Research Institute Francie van Zijl Drive Tygerberg 7505 South Africa
The Aurum Institute Tembisa ClinicalResearch Centre Cnrer Rev RTJ Namane and Flint MazibukoDrive Tembisa 1632 South Africa
Phoenix CRS 66 Pandora Street Durban 4068 South Africa
Trident Clinical 12 Angel Street Kimberley 8301 South Africa
CRISMO Research Centre Corner Joubert and Hospital Street Germiston 1401 South Africa
CAPRISA Springfield Clinical Research Site Dr RD Naidoo Drive Durban 4091 South Africa
Perinatal HIV Research Unit Aeroton 66 Sailor Malan Drive Johannesburg 2013 South Africa
Aurum Tembisa Clinic 4 539-541 Reverend RTJ Namane Drive Tembisa 1632 South Africa
Josha Research 28 East Burger Street Bloemfontein 9300 South Africa
FCRN Clinical Trial Centre 107 General Hertzog Road Vereeniging 1929 South Africa
Emavundleni Clinical Research Site 14 Sonwabile Drive Cape Town 7750 South Africa
Setshaba Research Centre 2088 Block H, Soshanguve Pretoria 0152 South Africa
Synergy Biomed Research Institute 3 Tudor Court, 280 Oxford Road East London 5201 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation 500 Fifth Avenue North Seattle WA 98109 United States of America
Wellcome Trust 215 Euston Road, London, NW1 2BE London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bill and Melinda GatesMedical Research Institute One Kendall Square, Building600, Suite 6-301 Cambridge 02139 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Michele Botha michelle.botha@iqvia.com +27126712200 1021 Lenchen Avenue North
City Postal code Country Position/Affiliation
Centurion 0157 South Africa Manager Global Site Activation
Role Name Email Phone Street address
Scientific Enquiries Gates Medical Research Institute clinical.trials@gatesmri.org +18577022108 One Kendall Square Building 600
City Postal code Country Position/Affiliation
Massachusetts 02139 United States of America Sponsor
Role Name Email Phone Street address
Principal Investigator Lee Fairlie lfairlie@wrhi.ac.za +27827809997 7 Esselen Street
City Postal code Country Position/Affiliation
Johannesburg 2001 South Africa National Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Gates Medical Research Institute clinical.trials@gatesmri.org +18577022108 One Kendall Square Building 600
City Postal code Country Position/Affiliation
Massachusetts 02139 United States of America Sponsor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Sponsor is committed to responsible data sharing regarding the clinical trials they sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of completion the final study report. Access is provided after as earch proposal is submitted and has received approval from the Independent Review Panel and after Data Sharing Agreement is in place.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 23/09/2024 Updated as per Protocol Amendment 2. A Phase 3 trial to assess efficacy and safety of Mycobacterium tuberculosis (Mtb) vaccine in adolescents and adults. Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 19/01/2024 Background summary added The trial will include 2 groups (M72/AS01E-4 group and placebo group). Participants will receive 2 doses ofeither M72/AS01E-4 or placebo based on randomization, administered intramuscularly (IM) approximately onemonth apart. This current trial is designed a) to confirm the results of the Phase 2b trial and b) to describesafety, immunogenicity, and vaccine efficacy (VE) in people living with HIV (PLHIV) and in an IGRA (Interferongamma release assay) - negative, HIV (human immunodeficiency virus) -negative population. Specifically, theprimary objective of the trial is to demonstrate VE for the prevention of laboratory-confirmed pulmonary TB inIGRA-positive participants without HIV infection, and secondary objectives include safety, reactogenicity,immunogenicity, and descriptive VE in IGRA-negative participants and in participants with well-controlled HIVinfection. Given the substantial morbidity and mortality associated with tuberculosis (TB), the challenges associated with TB treatment, and the limited options for prevention, a vaccine is urgently needed, both to protect against disease, including the progression from latent Mycobacterium tuberculosis (Mtb) infection to active TB, and to accelerate the end of the TB epidemic. GlaxoSmithKline Biologicals, SA (GSK) developed M72/AS01E-4, an investigational TB vaccine, to protect against the development of TB in Mtb-infected adolescents and adults. In the previously completed Phase 2b trial, the investigational M72/AS01E-4 Mtb vaccine conferred approximately 50% protection at 36 months against developing laboratory-confirmed pulmonary (TB) when administered to adults who were interferon gamma release assay (IGRA)-positive, and human immunodeficiency virus (HIV)-negative. This Phase 3 trial will include 2 groups (M72/AS01E-4 group and placebo group). Participants will receive 2 doses of either M72/AS01E-4 or placebo based on randomization, administered intramuscularly (IM) approximately one month apart. The trial is designed a) to confirm the results of the Phase 2b trial and b) to describe safety, immunogenicity, and vaccine efficacy (VE) in people living with HIV (PLHIV) and in an IGRA-negative, HIV (human immunodeficiency virus) -negative population. Specifically, the primary objective of the trial is to demonstrate VE for the prevention of laboratory-confirmed pulmonary TB in IGRA-positive participants without HIV infection, and secondary objectives include safety, reactogenicity, immunogenicity, and descriptive VE in IGRA-negative participants and in participants with well- controlled HIV infection.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 23/09/2024 Updated information actual start of trial. Given the substantial morbidity and mortality associated with tuberculosis (TB), the challenges associated with TB treatment, and the limited options for prevention, a vaccine is urgently needed, both to protect against disease, including the progression from latent Mycobacterium tuberculosis (Mtb) infection to active TB, and to accelerate the end of the TB epidemic. GlaxoSmithKline Biologicals, SA (GSK) developed M72/AS01E-4, an investigational TB vaccine, to protect against the development of TB in Mtb-infected adolescents and adults. In the previously completed Phase 2b trial, the investigational M72/AS01E-4 Mtb vaccine conferred approximately 50% protection at 36 months against developing laboratory-confirmed pulmonary (TB) when administered to adults who were interferon gamma release assay (IGRA)-positive, and human immunodeficiency virus (HIV)-negative. This Phase 3 trial will include 2 groups (M72/AS01E-4 group and placebo group). Participants will receive 2 doses of either M72/AS01E-4 or placebo based on randomization, administered intramuscularly (IM) approximately one month apart. The trial is designed a) to confirm the results of the Phase 2b trial and b) to describe safety, immunogenicity, and vaccine efficacy (VE) in people living with HIV (PLHIV) and in an IGRA-negative, HIV (human immunodeficiency virus) -negative population. Specifically, the primary objective of the trial is to demonstrate VE for the prevention of laboratory-confirmed pulmonary TB in IGRA-positive participants without HIV infection, and secondary objectives include safety, reactogenicity, immunogenicity, and descriptive VE in IGRA-negative participants and in participants with well- controlled HIV infection. The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA- Negative Cohort and Human Immunodeficiency virus (HIV) Cohort.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 22/06/2026 Updated as per trial reviewer comments received 10Jun2026. The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA- Negative Cohort and Human Immunodeficiency virus (HIV) Cohort. The study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mtb vaccine when administered intramuscularly (IM) on a 0,1-month schedule to adolescents and adults. This trial will be conducted in 3 cohorts: Interferon gamma release assay (IGRA)-positive Cohort, IGRA- Negative Cohort and Human Immunodeficiency virus (HIV) Cohort. The trial will include 2 groups (M72/AS01E-4 group and placebo group). Participants will receive 2 doses of either M72/AS01E-4 or placebo based on randomization, administered intramuscularly (IM) approximately one month apart. This current trial is designed a) to confirm the results of the Phase 2b trial and b) to describe safety, immunogenicity, and vaccine efficacy (VE) in people living with HIV (PLHIV) and in an IGRA (Interferon gamma release assay) - negative, HIV (human immunodeficiency virus) -negative population. Specifically, the primary objective of the trial is to demonstrate VE for the prevention of laboratory-confirmed pulmonary TB in IGRA-positive participants without HIV infection, and secondary objectives include safety, reactogenicity, immunogenicity, and descriptive VE in IGRA-negative participants and in participants with well-controlled HIV infection.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 30/08/2024 update with start date 15 Apr 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 23/09/2024 Updated to actual start date. 15 Apr 2024 05 Mar 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 23/09/2024 Updated to actual anticipated last follow up. 01 Aug 2029 30 Apr 2028
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 30/08/2024 updated as per protocol amendment 26000 20000
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 08/05/2025 Updated as per the final number 20081
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 18/02/2026 Updated to actual target sample size as per study. 20081 20080
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 10/06/2026 Update as per total number in intervention. 20080 20081
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 13/08/2024 Recruitment started Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 06/05/2025 Updated as enrollment has been closed. Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 24/01/2024 PACTR Admin 1. Participant must be 15 to 44years of age (inclusive), at the time of signing the consent or assent. 2. Capable of giving informed consent or informed assent (as appropriate). For participants below the age of consent, the participant’s parent,or legally authorized representative(LAR) will be required to sign a statement of informed consent, in addition to the minor’s signed statement of assent. 3. In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of diary cards as applicable, and returnfor follow-up visits). 4. Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety. 5. Agree to provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial.6. Healthy, or with preexisting stable disease, as established by medical history and physical examination and as determined by the investigator. Pre existing stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrollment. 7.Negative sputum Xpert Ultra or similar assay result at screening (this criterion can be waived if participant is unable to produce sufficient sputum) 8. Both males and females are included.Females are included with restrictions. 9.HIV-negative test result at screening (IGRA-Positive Cohort and IGRA-Negative Cohort only) 10. HIV Cohort only: Participants with documented HIV infection who fulfill all of the following criteria: •have reactive anti-HIV antibody at screening • have been on ARTfor at least 3 consecutive months at screening and agree to remain on ART throughout the trial •have documented HIV RNA <200copies/mL at screening • haveCD4+ cell count ≥200 cells/μL at screening • have had TPT in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators • have an IGRA-positiveor negative result atscreening 1. Participant must be 15 to 44years of age (inclusive), at the time of signing the consent or assent. 2. Capable of giving informed consent or informed assent (as appropriate). For participants below the age of consent, the participant’s parent,or legally authorized representative(LAR) will be required to sign a statement of informed consent, in addition to the minor’s signed statement of assent. 3. In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of diary cards as applicable, and returnfor follow-up visits). 4. Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety. 5. Agree to provide updated contact information as necessary, and have no current plans to relocate from the trial area for the duration of the trial. 6. Healthy, or with preexisting stable disease, as established by medical history and physical examination and as determined by the investigator. Pre existing stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrollment. 7.Negative sputum Xpert Ultra or similar assay result at screening (this criterion can be waived if participant is unable to produce sufficient sputum) 8. Both males and females are included.Females are included with restrictions. 9.HIV-negative test result at screening (IGRA-Positive Cohort and IGRA-Negative Cohort only) 10. HIV Cohort only: Participants with documented HIV infection who fulfill all of the following criteria: •have reactive anti-HIV antibody at screening • have been on ARTfor at least 3 consecutive months at screening and agree to remain on ART throughout the trial •have documented HIV RNA <200copies/mL at screening • haveCD4+ cell count ≥200 cells/μL at screening • have had TPT in the past and are not receiving TPT at the time of screening, according to the judgment of the investigators • have an IGRA
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 24/01/2024 PACTR Admin 1. Current TB, or history of TB ortreatment for TB disease 2.Clinical suspicion of pulmonaryTB at screening, defined as aparticipant presenting with one ormore of the following signs orsymptoms: unexplained cough,unexplained fever, night sweats,unintentional weight loss,hemoptysis, pleuritic chest pain3. Any current medical,psychiatric, occupational, orsubstance abuse problems 4.Any confirmed or suspectedimmunosuppressive orimmunodeficient conditionresulting from disease (e.g.,invasive, or malignant cancers),other than HIV infection in theHIV Cohort 5. Any cytotoxicdrugs or administration ofmedications known to have amajor impact on the immunesystem, as determined by theinvestigator, within 90 days priorto Day 1. 6. Planned receipt ofblood, or blood products duringthe trial period 7. Receipt orplanned receipt of any vaccine inthe period starting 28 daysbefore, and ending 28 days after,each dose of the trial vaccine 8.History of previous administrationof an experimental Mtb vaccineincluding M72/AS01E in aprevious trial 9. History of allergy or hypersensitivity to the trialintervention, excipients, orrelated substances Diagnosticassessments 10. An indeterminate IGRA test result atscreening 11. Female participants with any one of thefollowing conditions: currentlypregnant or lactating 12. Only inthe HIV Cohort: Safety laboratory values at screening that are ofconcern, based on investigator’s judgment 13. Participation in aninterventional clinical trial inwhich the participant has been orwill be exposed to an investigational product(pharmaceutical product ordevice), within 28 days prior tosigning consent or assent, orduring the trial period. 14.Individuals who are acting aspersonnel for this trial, or whohave immediate family members who are acting as personnel forthis trial 15. Child in Care,defined as a child who is underthe care (control or protection) ofan agency or organization. 1. Current TB, or history of TB ortreatment for TB disease 2.Clinical suspicion of pulmonaryTB at screening, defined as aparticipant presenting with one ormore of the following signs orsymptoms: unexplained cough,unexplained fever, night sweats,unintentional weight loss,hemoptysis, pleuritic chest pain 3. Any current medical,psychiatric, occupational, orsubstance abuse problems 4.Any confirmed or suspectedimmunosuppressive orimmunodeficient conditionresulting from disease (e.g.,invasive, or malignant cancers),other than HIV infection in theHIV Cohort 5. Any cytotoxicdrugs or administration ofmedications known to have amajor impact on the immunesystem, as determined by theinvestigator, within 90 days priorto Day 1. 6. Planned receipt ofblood, or blood products duringthe trial period 7. Receipt orplanned receipt of any vaccine inthe period starting 28 daysbefore, and ending 28 days after,each dose of the trial vaccine 8.History of previous administrationof an experimental Mtb vaccineincluding M72/AS01E in aprevious trial 9. History of allergy or hypersensitivity to the trialintervention, excipients, orrelated substances Diagnosticassessments 10. An indeterminate IGRA test result atscreening 11. Female participants with any one of thefollowing conditions: currentlypregnant or lactating 12. Only inthe HIV Cohort: Safety laboratory values at screening that are ofconcern, based on investigator’s judgment 13. Participation in aninterventional clinical trial inwhich the participant has been orwill be exposed to an investigational product(pharmaceutical product ordevice), within 28 days prior tosigning consent or assent, orduring the trial period. 14.Individuals who are acting aspersonnel for this trial, or whohave immediate family members who are acting as personnel forthis trial 15. Child in Care,defined as a child who is underthe care (control or protection) ofan agency or organization.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 20/06/2025 Typo's corrected 1. Current TB, or history of TB ortreatment for TB disease 2.Clinical suspicion of pulmonaryTB at screening, defined as aparticipant presenting with one ormore of the following signs orsymptoms: unexplained cough,unexplained fever, night sweats,unintentional weight loss,hemoptysis, pleuritic chest pain 3. Any current medical,psychiatric, occupational, orsubstance abuse problems 4.Any confirmed or suspectedimmunosuppressive orimmunodeficient conditionresulting from disease (e.g.,invasive, or malignant cancers),other than HIV infection in theHIV Cohort 5. Any cytotoxicdrugs or administration ofmedications known to have amajor impact on the immunesystem, as determined by theinvestigator, within 90 days priorto Day 1. 6. Planned receipt ofblood, or blood products duringthe trial period 7. Receipt orplanned receipt of any vaccine inthe period starting 28 daysbefore, and ending 28 days after,each dose of the trial vaccine 8.History of previous administrationof an experimental Mtb vaccineincluding M72/AS01E in aprevious trial 9. History of allergy or hypersensitivity to the trialintervention, excipients, orrelated substances Diagnosticassessments 10. An indeterminate IGRA test result atscreening 11. Female participants with any one of thefollowing conditions: currentlypregnant or lactating 12. Only inthe HIV Cohort: Safety laboratory values at screening that are ofconcern, based on investigator’s judgment 13. Participation in aninterventional clinical trial inwhich the participant has been orwill be exposed to an investigational product(pharmaceutical product ordevice), within 28 days prior tosigning consent or assent, orduring the trial period. 14.Individuals who are acting aspersonnel for this trial, or whohave immediate family members who are acting as personnel forthis trial 15. Child in Care,defined as a child who is underthe care (control or protection) ofan agency or organization. 1. Current TB, or history of TB or treatment for TB disease 2.Clinical suspicion of pulmonary TB at screening, defined as a participant presenting with one or more of the following signs or symptoms: unexplained cough, unexplained fever, night sweats, unintentional weight loss, hemoptysis, pleuritic chest pain 3. Any current medical, psychiatric, occupational, or substance abuse problems 4.Any confirmed or suspectedimmunosuppressive orimmunodeficient conditionresulting from disease (e.g.,invasive, or malignant cancers),other than HIV infection in theHIV Cohort 5. Any cytotoxicdrugs or administration ofmedications known to have amajor impact on the immunesystem, as determined by theinvestigator, within 90 days priorto Day 1. 6. Planned receipt ofblood, or blood products duringthe trial period 7. Receipt orplanned receipt of any vaccine inthe period starting 28 daysbefore, and ending 28 days after,each dose of the trial vaccine 8.History of previous administrationof an experimental Mtb vaccineincluding M72/AS01E in aprevious trial 9. History of allergy or hypersensitivity to the trialintervention, excipients, orrelated substances Diagnosticassessments 10. An indeterminate IGRA test result atscreening 11. Female participants with any one of thefollowing conditions: currentlypregnant or lactating 12. Only inthe HIV Cohort: Safety laboratory values at screening that are ofconcern, based on investigator’s judgment 13. Participation in aninterventional clinical trial inwhich the participant has been orwill be exposed to an investigational product(pharmaceutical product ordevice), within 28 days prior tosigning consent or assent, orduring the trial period. 14.Individuals who are acting aspersonnel for this trial, or whohave immediate family members who are acting as personnel forthis trial 15. Child in Care,defined as a child who is underthe care (control or protection) ofan agency or organization.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/08/2024 Change group size from 13 000 to 10 000 as per protocol amendment. The assumptions on vaccine efficacy (VE) and TB incidence rate in protocol Version 1 were deemed overly conservative, requiring too many cases to satisfy primary endpoint and too long a follow-up to conclude on VE, thus leading to a potential delay in the availability and public health impact of the vaccine. The protocol was therefore amended Experimental Group, Mycobacteriumtuberculosis investigationalvaccine, A 0.5 mL dose ofM72/AS01E-4 - 10μgM72, reconstituted withAS01E-4, aGlaxoSmithKline(GSK) proprietaryadjuvant systemcontaining 25 μg MPL(3-O-desacyl-4-monophosphoryl lipidA, produced by GSK),and 25 μg QS-21(Quillaja saponariaMolina, fraction 21)., 2 doses of M72/AS01E-4- 1 month apart, Active group, 13000, Experimental Group, Mycobacteriumtuberculosis investigationalvaccine, A 0.5 mL dose ofM72/AS01E-4 - 10μgM72, reconstituted withAS01E-4, aGlaxoSmithKline(GSK) proprietaryadjuvant systemcontaining 25 μg MPL(3-O-desacyl-4-monophosphoryl lipidA, produced by GSK),and 25 μg QS-21(Quillaja saponariaMolina, fraction 21)., 2 doses of M72/AS01E-4- 1 month apart, Active group, 10000,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 23/06/2025 Change group size from 13 000 to 10 000 as per protocol amendment. The assumptions on vaccine efficacy (VE) and TB incidence rate in protocol Version 1 were deemed overly conservative, requiring too many cases to satisfy primary endpoint and too long a follow-up to conclude on VE, thus leading to a potential delay in the availability and public health impact of the vaccine. The protocol was therefore amended Experimental Group, Mycobacteriumtuberculosis investigationalvaccine, A 0.5 mL dose ofM72/AS01E-4 - 10μgM72, reconstituted withAS01E-4, aGlaxoSmithKline(GSK) proprietaryadjuvant systemcontaining 25 μg MPL(3-O-desacyl-4-monophosphoryl lipidA, produced by GSK),and 25 μg QS-21(Quillaja saponariaMolina, fraction 21)., 2 doses of M72/AS01E-4- 1 month apart, Active group, 10000, Experimental Group, Mycobacteriumtuberculosis investigationalvaccine, A 0.5 mL dose ofM72/AS01E-4 - 10μgM72, reconstituted withAS01E-4, aGlaxoSmithKline(GSK) proprietaryadjuvant systemcontaining 25 μg MPL(3-O-desacyl-4-monophosphoryl lipidA, produced by GSK),and 25 μg QS-21(Quillaja saponariaMolina, fraction 21)., 2 doses of M72/AS01E-4- 1 month apart, Active group, 10041,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 30/08/2024 Changed group size from 13 000 to 10 000 due to protocol amendment. The assumptions on vaccine efficacy (VE) and TB incidence rate in protocol Version 1 were deemed overly conservative, requiring too many cases to satisfy primary endpoint and too long a follow-up to conclude on VE, thus leading to a potential delay in the availability and public health impact of the vaccine. The protocol was therefore amended Control Group, Placebo, 0.5 mL normal saline -0.9% NaCl, 2 doses of placebo - 1month apart, Placebo group, 13000, Placebo Control Group, Placebo, 0.5 mL normal saline -0.9% NaCl, 2 doses of placebo - 1month apart, Placebo group, 10000, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 23/06/2025 Changed group size from 13 000 to 10 000 due to protocol amendment. The assumptions on vaccine efficacy (VE) and TB incidence rate in protocol Version 1 were deemed overly conservative, requiring too many cases to satisfy primary endpoint and too long a follow-up to conclude on VE, thus leading to a potential delay in the availability and public health impact of the vaccine. The protocol was therefore amended Control Group, Placebo, 0.5 mL normal saline -0.9% NaCl, 2 doses of placebo - 1month apart, Placebo group, 10000, Placebo Control Group, Placebo, 0.5 mL normal saline -0.9% NaCl, 2 doses of placebo - 1month apart, Placebo group, 10040, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/06/2026 Duplicate intervention to Mycobacterium tuberculosis investigational vaccine. Experimental Group, Mycobacteriumtuberculosis investigationalvaccine, A 0.5 mL dose ofM72/AS01E-4 - 10μgM72, reconstituted withAS01E-4, aGlaxoSmithKline(GSK) proprietaryadjuvant systemcontaining 25 μg MPL(3-O-desacyl-4-monophosphoryl lipidA, produced by GSK),and 25 μg QS-21(Quillaja saponariaMolina, fraction 21)., 2 doses of M72/AS01E-4- 1 month apart, Active group, 10041,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 10/06/2026 Duplicate intervention to Placebo group Control Group, Placebo, 0.5 mL normal saline -0.9% NaCl, 2 doses of placebo - 1month apart, Placebo group, 10040, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 30/08/2024 updated as per protocol amendment Primary Outcome, 1. IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weightloss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding “trace positive”), for at least 1 of the 3 sputum samples collected at 3 different visits, preferably within a 7-day time frame, before initiation of TB treatment., Up to Month 61 Primary Outcome, 1. IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weightloss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding “trace positive”), from the same or from different sputum samples collected during the 3 suspected visits, preferably within a 7-day time frame, before initiation of TB treatment., Up to Month 61
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Primary Outcome, 1. IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weightloss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding “trace positive”), from the same or from different sputum samples collected during the 3 suspected visits, preferably within a 7-day time frame, before initiation of TB treatment., Up to Month 61 Primary Outcome, 1. IGRA-Positive Cohort: Number of participants with laboratory-confirmed pulmonary tuberculosis (TB)Laboratory-confirmed pulmonary TB case is defined as a participant with suspected pulmonary TB presenting with one or more of the following signs or symptoms: unexplained cough, unintentional weightloss, hemoptysis, unexplained fever, night sweats, pleuritic chest pain; who has at least 2 positive Mtb test results (positive Mtb culture and/or positive test result from Xpert Ultra or similar assay, excluding “trace positive”), from the same or from different sputum samples collected during the 3 suspected visits, preferably within a 7-day time frame, before initiation of TB treatment., Up to Month 49
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Secondary Outcome, IGRA-Negative Cohort: Number of participants with sustained QuantiFERON®-TB Gold Plus assay conversion, Up to Month 61 Secondary Outcome, IGRA-Negative Cohort: Number of participants with sustained QuantiFERON®-TB Gold Plus assay conversion, Up to Month 49
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Secondary Outcome, IGRA-Negative Cohort: Number of participants with laboratory-confirmed pulmonary TB, Up to month 61 Secondary Outcome, IGRA-Negative Cohort: Number of participants with laboratory-confirmed pulmonary TB, Up to month 49
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Secondary Outcome, HIV Cohort: Number of participants with laboratory-confirmed pulmonary TB, Up to month 61 Secondary Outcome, HIV Cohort: Number of participants with laboratory-confirmed pulmonary TB, Up to month 49
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Secondary Outcome, All Cohorts: Number of participants with SAEs related to study participation, Up to month 61 Secondary Outcome, All Cohorts: Number of participants with SAEs related to study participation, Up to month 49
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Secondary Outcome, All cohorts: Number of participants with Geometric mean concentration (GMC) of M72-specificantibodies, At Day 1, Month 1, Month 2, Month 7, Month 13, Month37, and Month 61 Secondary Outcome, All cohorts: Number of participants with Geometric mean concentration (GMC) of M72-specificantibodies, At Day 1, Month 1, Month 2, Month 7, Month 13, Month37, and Month 49
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 23/09/2024 Updated 61 to 49 as per Protocol Amendment 2. Secondary Outcome, All cohorts: Number of participants with seropositivity of M72-specific antibodies, At Day 1, Month 1, Month 2, Month 7, Month 13, Month37, and Month 61 Secondary Outcome, All cohorts: Number of participants with seropositivity of M72-specific antibodies, At Day 1, Month 1, Month 2, Month 7, Month 13, Month37, and Month 49
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 19/12/2024 Country/site is dropped from study. Polana Canico Health Research and Training Centre, Polana Canico B Neighborhood, N178, Costa do Sol, Maputo, 00000, Mozambique
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 19/12/2024 Mozambique/site dropped from study. Sites were never activated and did not participate. Manhica Health Research Centre, Caixa Postal 1929, Th Street, Maputo, 1102, Mozambique
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/12/2024 Mozambique was dropped from study. Sites was never activated.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/06/2026 Approval received 19 Dec 2023 FALSE, National Health Sciences Research Commitee, PO Box 30377, Lilongwe, 0000, Malawi, 15 Sep 2023, , 2651789400, waleke@gmail.com, 25726_28136_4737.pdf FALSE, National Health Sciences Research Commitee, PO Box 30377, Lilongwe, 0000, Malawi, 15 Sep 2023, , 2651789400, waleke@gmail.com, 25726_28136_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 10/06/2026 Approval received 19 Dec 2023 FALSE, National Health Sciences Research Commitee, Po Box 30377, Lilongwe, 0000, Malawi, 15 Sep 2023, , 2651789400, waleke@gmail.com, 25726_28137_4737.pdf TRUE, National Health Sciences Research Commitee, Po Box 30377, Lilongwe, 0000, Malawi, 15 Sep 2023, 19 Dec 2023, 2651789400, waleke@gmail.com, 25726_28137_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 13/08/2024 new approval TRUE, COMITE NACIONAL DE BIOETICA PARA A SAUDE , Av. Eduardo Mondlane, No. 1008, Salvador Allende, Maputo, 00000, Mozambique, , 05 Aug 2024, +258824066350, cnbsmocambique@gmail.com, 25726_29885_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/12/2024 Mozambique was dropped from study. Sites was never activated.
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 28/07/2026 This update is to ensure that the same details are included across registries. Scientific Enquiries, Erica, Esteve, Ms., erika.esteve@iqvia.com, , +34915578500, Calle Provenca, Block 392, Barcelona, 08025, Spain, Medical Monitor Scientific Enquiries, Gates Medical , Research Institute, Ms., clinical.trials@gatesmri.org, , +18577022108, One Kendall Square Building 600, Massachusetts, 02139, United States of America, Sponsor