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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307901658960 Date of Registration: 27/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Phase 1b, Multicenter, Randomized, Placebo-controlled, Observer-blinded, Dose-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar.
Official scientific title A Phase 1b, Multicenter, Randomized, Placebo-controlled, Observer-blinded, Dose-escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar.
Brief summary describing the background and objectives of the trial Schistosomiasis is the most prevalent tropical disease having been reported in 78 countries, spanning Africa, Asia and Latin America, affecting impoverished communities without access to safe drinking water and adequate sanitation programs. Estimations show that schistosomiasis affects at least 230 million people worldwide, resulting in significant health and socio-economic burdens. Schistosomiasis ranks second only to malaria as the most common parasitic disease and is the deadliest neglected tropical disease (NTD). In the Africa region alone, about 280,000 deaths annually are attributed to schistosomiasis; furthermore, an estimated 3.3 million disability-adjusted life years, a measure of overall disease burden expressed as the number of years lost due to ill-health, disability, or early death, are lost annually. In 2017, at least 220.8 million people required preventive treatment for schistosomiasis, 90% of which lived in Africa The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated. A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60). Cohort A will receive the low-dose antigen formulation (10 μg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 μg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 μg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) b
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Schistosomiasis
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/08/2023
Actual trial start date 17/11/2023
Anticipated date of last follow up 01/12/2024
Actual Last follow-up date 19/05/2025
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group drug Cohort A will receive the low-dose antigen formulation(10 μg Sm-p80 + 5 μg GLA-SE) Cohort B will receive the medium-dose antigen formulation (30 μg Sm-p80 + 5 μg GLA-SE) Cohort C will receive the high-dose antigen formulation (100 μg Sm-p80 + 5 μg GLA-SE) 56 days Cohort A will receive the low-dose antigen formulation(10 μg Sm-p80 + 5 μg GLA-SE) Cohort B will receive the medium-dose antigen formulation (30 μg Sm-p80 + 5 μg GLA-SE) Cohort C will receive the high-dose antigen formulation (100 μg Sm-p80 + 5 μg GLA-SE) 105
Control Group Placebo Cohort A will receive the placebo formulation Cohort B will receive the placebo formulation Cohort C will receive the placebo formulation 56 days Cohort A will receive the placebo formulation Cohort B will receive the placebo formulation Cohort C will receive the placebo formulation 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Healthy male or female participants aged 20 to 59 years at the time of consent. 2. Participant who has completed the deworming using praziquantel (PZQ) and albendazole (ABZ) according to local guidelines, with the last dose of PZQ/ABZ administered at least 5 weeks prior to first dose of study product. 3. Participant who, after the nature of the study has been explained, has voluntarily given informed consent, according to the local regulatory requirements, prior to study entry. 4. Participant who can comply with the study procedures and available for the entire duration of the study (32 weeks). 5. Individuals in good health as determined by the outcome of medical history, physical examination, hematology and biochemistry tests at the time of screening and the clinical judgment of the investigator. 6. Women of childbearing potential* with negative urinary test result on a human chorionic gonadotropin pregnancy test on the day of randomization, before receiving any study product. 7. Males or females of childbearing potential who are using an effective birth control method recommended by the national health system for at least four (4) weeks before the first vaccination (for female participants only) and up to four (4) weeks after the third vaccination (i.e., for at least 4 months). 1. Participant with major congenital abnormalities which in the opinion of investigator may affect the subject’s participation in the study. 2. Participant concomitantly enrolled or scheduled to be enrolled in another trial. 3. Positive rapid test for HIV 1-2 confirmed by a positive blood test for human immunodeficiency virus (positive antibodies to HIV 1/2). 4. Participant seropositive for hepatitis B virus surface antigen (HBsAg). 5. Participant seropositive for hepatitis C virus (Antibodies to HCV). 6. Participant with active or chronic Schistosomiasis infection defined by a positive result for microscopy (Urine filtration, Kato-Katz (KK)) and point-of-care – circulating cathodic antigen (POC –CCA) and/or real-time PCR. 7. Participant with soiled transmitted helminths infections (STH) as diagnosed by microscopy (KK) and/or real-time PCR. 8. Participant with malaria infection/malaria as diagnosed by the blood smear. 9. Any other confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections. 10. Body mass index (BMI) ≥ 35 kg/m2 11. Chronic use of systemic steroids (>2 mg/kg/day or >20 mg/day prednisolone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs. 12. Receipt of blood or blood-derived products in the past 3 months. 13. Participant who has received other vaccines 4 weeks prior to test vaccination or plans to receive any vaccine within 4 weeks of last dose of study vaccine, exception made for COVID-19 vaccines. 14. Known history of allergy to study vaccine components and/or excipients or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial. 15. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time resulting in contraindication for IM injections/blood extractions. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 59 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 20/03/2023 Comite dEthique Pour la researche en sante
Ethics Committee Address
Street address City Postal code Country
03 BP 7009 Ouagadougou 03 BP7009 Burkina Faso
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 05/06/2023 Comite d Ethique de la Recherche Biomedicale
Ethics Committee Address
Street address City Postal code Country
Agence de Medicament de Madagascar, BP8145 - 101, Antananarivo, Madagascar Antananarivo BP8145 Madagascar
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Proportion of participants with of any Serious Adverse Events (SAEs)/ adverse events of special interest (AESI) from the time of the first study vaccination through the final study visit. [Time Frame: Day 1 through Day 224] 2. Proportion of participants with immediate adverse events (reactogenicity events) within 60 min from the time of each study vaccination [Time Frame: Day 1 through Day 56] 3. Proportion of participants with solicited local and solicited systemic AEs as measured for 7 days (inclusive) following immunization with the three different dose formulations. [Time Frame: Day 1 through Day 63] 4. Proportion of participants with unsolicited AEs from the time of vaccination until 28 days post immunization with the three different dose formulations. [Time Frame: Day 1 through Day 84] 5. Proportion of participants with clinical safety laboratory adverse events measured at 7 days and 28 days after each study vaccination. [Time Frame: Day 1 through Day 84] Day 1 through Day 224
Secondary Outcome 6. For Sm-p80 IgG antibodies, seroconversion rate at approximately 4 weeks (28 days) after each dose of study vaccination as compared to baseline [Time Frame: Day 1 through Day 84] 7. For Sm-p80 IgG antibodies, seroconversion rate at approximately 24 weeks after third dose of study vaccination as compared to baseline [Time Frame: Day 1 through Day 224] 8. Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 4 weeks after each dose of study vaccination. [Time Frame: Day 1 through Day 84] 9. Geometric Mean Titers (GMTs) of serum Sm-p80 IgG antibodies at approximately 24 weeks after third dose of study vaccination. [Time Frame: Day 1 through Day 224] Day 1 through Day 224
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groupe de Recherche Action en Sante Ouagadougou, Burkina Faso Ouagadougou Burkina Faso
Madagascar Institute for Vaccine Research Antananarivo, Madagascar Antananarivo Madagascar
FUNDING SOURCES
Name of source Street address City Postal code Country
European Commission Horizon 2020 Trinity Lane The Old Schools Cambridge United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Vaccine Institute SNU Research Park, 1 Gwanak-ro, Gwanak-gu Seoul 08826 Korea, Republic of Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Florian Marks fmarks@ivi.int +447402515431 SNU Research Park, 1 Gwanak-ro, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul 08826 Korea, Republic of Deputy Director General
Role Name Email Phone Street address
Scientific Enquiries Florian Marks fmarks@ivi.int +447402515431 SNU Research Park, 1 Gwanak-ro, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul 08826 Korea, Republic of Deputy Director General
Role Name Email Phone Street address
Public Enquiries Birkneh Tadesse Birkneh.Tadesse@ivi.int +8228811231 SNU Research Park, 1 Gwanak-ro, Gwanak-gu
City Postal code Country Position/Affiliation
Seoul 08826 Korea, Republic of Research Scientist
Role Name Email Phone Street address
Principal Investigator Sodiomon Bienvenu SIRIMA s.sirima@gras.bf +22670200444 06 BP 10248 Ouagadougou 06
City Postal code Country Position/Affiliation
Ouagadougou Burkina Faso Chief Executive Officer
Role Name Email Phone Street address
Principal Investigator Raphael Rakotozandrindrainy rakrapha13@gmail.com +261320210812 University of Antananarivo established in Campus d Ankatso, Antananarivo 101
City Postal code Country Position/Affiliation
Antananarivo Madagascar Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Two years after the study databases are sealed, the database will be made available to external investigators upon request reviewed by VASA consortium and made available without individual identifiers in the VASA repository. The consortium makes combined decisions on the sharing of isolates and biological specimens to external research groups after consideration of reasonable requests. Study Protocol The data without individual identifiers will be available 2 Years after the study database lock. All individual data will stay strictly confidential. Analyzed data may be presented in scientific conferences and published in peer-reviewed scientific journals with a priority given to open access publications to ensure maximum accessibility to the scientific and public health community.
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 Trial description 22/06/2023 Background of the trial added. The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated. A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60). Cohort A will receive the low-dose antigen formulation (10 μg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 μg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 μg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio. A subset of five out of 20 subjects in each cohort will be sampled by convenience to enable us to further characterize the immune response using the peripheral blood mononuclear cells (PBMC). The Primary Objective of the study is to evaluate the safety and tolerability of 3 different dose formulations (low dose, medium dose, and high dose) of SchistoShield® vaccine given intramuscularly on D0, D28 and D56 to healthy participants 2018 to 59 years of age in Burkina Faso and Madagascar. Schistosomiasis is the most prevalent tropical disease having been reported in 78 countries, spanning Africa, Asia and Latin America, affecting impoverished communities without access to safe drinking water and adequate sanitation programs. Estimations show that schistosomiasis affects at least 230 million people worldwide, resulting in significant health and socio-economic burdens. Schistosomiasis ranks second only to malaria as the most common parasitic disease and is the deadliest neglected tropical disease (NTD). In the Africa region alone, about 280,000 deaths annually are attributed to schistosomiasis; furthermore, an estimated 3.3 million disability-adjusted life years, a measure of overall disease burden expressed as the number of years lost due to ill-health, disability, or early death, are lost annually. In 2017, at least 220.8 million people required preventive treatment for schistosomiasis, 90% of which lived in Africa The goal of this phase 1b, multicenter, randomized, placebo-controlled, observer-blinded, dose-escalation study is to assess the safety, tolerability, and immunogenicity of a three-dose regimen, spaced four weeks apart, given intramuscularly in healthy adults (20-59 years old). Three different dose formulations of the study product with varying antigen contents will be investigated. A total of 120 eligible participants will be recruited in 3 sequential cohorts (A, B, and C) in Burkina Faso (N=60) and in Madagascar (N=60). Cohort A will receive the low-dose antigen formulation (10 μg) or placebo, Cohort B will receive the medium-dose antigen formulation (30 μg) or placebo, and Cohort C will receive the high-dose antigen formulation (100 μg) or placebo; all antigens with 5 μg adjuvant (GLA-SE). In each cohort, volunteers will be randomized in a blinded manner into one of two arms, candidate vaccine or placebo, by a 3:1 ratio.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/04/2024 Updated Actual Start date 17 Nov 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 11/06/2025 Updated actual completion date 19 May 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 11/06/2025 Updated actual final no of participants 120
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 01/04/2024 Updated the current status of the trial. Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 11/06/2025 Updated the current status Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 22/06/2023 Email ID updated. TRUE, Comite dEthique Pour la researche en sante, 03 BP 7009, Ouagadougou, 03 BP7009, Burkina Faso, , 20 Mar 2023, +26625488937, kouetafla@yaho.com, 24338_24246_4737.pdf TRUE, Comite dEthique Pour la researche en sante, 03 BP 7009, Ouagadougou, 03 BP7009, Burkina Faso, , 20 Mar 2023, +26625488937, kouetafla@yahoo.com, 24338_24246_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 22/06/2023 Burkina Faso site contact details added Principal Investigator, Sodiomon Bienvenu, SIRIMA, Dr., s.sirima@gras.bf, , +22670200444, 06 BP 10248 Ouagadougou 06, Ouagadougou, , Burkina Faso, Chief Executive Officer
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 10/07/2023 Updated as per Query IPD will be available upon request to investigators following publication of results. Two years after the study databases are sealed, the database will be made available to external investigators upon request reviewed by VASA consortium and made available without individual identifiers in the VASA repository. The consortium makes combined decisions on the sharing of isolates and biological specimens to external research groups after consideration of reasonable requests.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 10/07/2023 Updated as per Query IPD will be available within 12 months of study completion. The data without individual identifiers will be available 2 Years after the study database lock.