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.: PACTR202407768096289 Date of Approval: 11/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Single dose HPV Immunobridging Study with New Vaccines I (SHINE I)
Official scientific title A Phase III, double-blind, randomized, multinational trial to evaluate safety and immunogenicity of INNOVAX Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) compared to GARDASIL®9 in a single-dose regimen in healthy girls and young women in Ghana and the Philippines
Brief summary describing the background and objectives of the trial Cervical cancer and HPV-associated diseases continue to cause a significant burden of disease, particularly in low- and middle-income countries. HPV vaccines are highly efficacious, yet the global vaccine coverage in girls younger-than-15 years of age is currently 21% for a first dose of HPV vaccine and 17% for full coverage. Gardasil®9, the only WHO prequalified nonavalent (9v) HPV vaccine, protects against oncogenic HPV types 16 and 18, (responsible for more than 70 percent of cervical cancer cases), and against 5 additional oncogenic types responsible for another 20 percent of cervical cancer cases, as well as low risk types HPV-6 and 11 which cause genital warts. In December 2022, the WHO revised its position paper for HPV vaccines recommending that girls 9-14 years of age and women 15-20 years of age be vaccinated with a single-dose or two-dose schedule based on the current evidence suggesting that a single dose has comparable efficacy and duration of protection as a 2-dose schedule and that a single-dose schedule should be considered for HPV vaccines for which efficacy or immunobridging data to vaccines with proven single-dose efficacy are available. The purpose of CVIA 104 is to generate immunobridging data for the investigational Innovax 9vHPV vaccine administered in a single-dose schedule compared to the Gardasil 9 which has demonstrated single dose efficacy, administered to healthy girls 9–14 years of age and young women 15–20 years of age. For each age cohort, non-inferiority (NI) of immune response for the Innovax 9vHPV vaccine to that of Gardasil 9 against oncogenic HPV types will be compared at 24 months post vaccination. Secondary objectives include evaluation of: NI of immune responses to HPV types 6 and 11 at 24 months; immune responses at several study timepoints; and safety and tolerability.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Infections and Infestations
Sub-Disease(s) or condition(s) being studied HPV Infection
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 03/01/2025
Actual trial start date 29/01/2025
Anticipated date of last follow up 03/06/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 1320
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Innovax 9vHPV vaccine Single dose of 0.5 mL administered IM 24 months following vaccination INNOVAX Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli); hereafter referred to as “Innovax 9vHPV vaccine”. 660
Control Group Gardasil 9 Single dose of 0.5 mL administered IM 24 months post vaccination Gardasil 9: Human Papillomavirus 9-valent recombinant vaccine containing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. 660 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Females between the ages of ≥9 - <15 years for Cohort 1 and ≥15 - ≤20 years for Cohort 2 at time of randomization. 2. Healthy as defined by the absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment. 3. Written informed consent obtained from the participant prior to randomization. For participants below the legal age of consent, written informed consent must be obtained from the participant’s parent(s)/legally authorized representative (LAR), and written informed assent must be obtained from the participant. 4. Anticipated ability and willingness to complete all study visits and evaluations. 5. Participant must be either of non-childbearing potential or, if of childbearing potential*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and on the day of vaccination), and must have been practicing adequate contraception (defined in Appendix III) for at least 21 days prior to vaccination and agrees to continue such precautions consistently through 2 months after vaccination, and agrees to not become pregnant through other means (e.g., artificial insemination and IVF) through 2 months after vaccination. *Female of childbearing potential is defined as having begun menstruation (achieved menarche) and not permanently infertile (e.g., due to bilateral tubal ligation, occlusion or removal, or post-total hysterectomy, or post-bilateral ovariectomy). 6. Living within the catchment area of the study without plans to move during the conduct of the study. 1.Acute medical illnesses (temporary exclusions) should be evaluated, treated, and improved prior to study randomization and vaccination. 2.Known history of abnormal cervical cytology, abnormal cervical biopsy results, treatment for genital warts or other HPV-associated disease (prior screening is not required for eligibility assessment). 3.Participant reports more than 4 lifetime sexual partners prior to enrollment. 4.Current or former participation in HPV vaccine related research. 5.Prior receipt of any HPV vaccine, or planned administration of any HPV vaccine other than study vaccines during the study period. 6.Received an investigational product within 30 days prior to randomization. 7.Currently participating in or planning to participate in another clinical research trial involving investigational product during the conduct of this study. 8Received or plans to receive a licensed inactivated vaccine or allergy desensitization injections within 7 days prior to or after study vaccination or a live attenuated vaccine within 28 days prior to or after study vaccination. 9Contraindication to intramuscular injections or history of bleeding or coagulation disorder. 10.History of anaphylaxis or serious allergic reactions following receipt of any vaccines. 11.History of allergy or hypersensitivity to any components of the study vaccine or Gardasil 9 (e.g., yeast, polysorbate 80, aluminum). 12.Planned administration or receipt of any immunoglobulins or blood products within 6 months prior to randomization or during the study. 13.Immunosuppressive or immunodeficient condition 14.Immunosuppressive or immune modulating medications 15.Malignancy or autoimmune disease 16.Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the study vaccine. 17.Medical condition that would interfere with or serves as a contraindication to protocol adherence or ability to give informed consent. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 9 Year(s) 20 Year(s) Female
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 22/10/2024 WCG IRB
Ethics Committee Address
Street address City Postal code Country
212 Carnegie Center, Suite 301 Princeton 08540 United States of America
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 11/10/2024 Navrongo Health Research Centre Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
P.O.BOX 114 Navrongo 0000 Ghana
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 15/10/2024 University of the East Ramon Magsaysay Memorial Medical Center Inc. Research Institute for Health Sciences Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Aurora Blvd. Quezon City 000 Philippines
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 30/10/2024 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P. O. BOX MB 190 Accra 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunoglobulin G (IgG) geometric mean concentration (GMC) against oncogenic HPV types (HPV-16, -18, -31, -33, -45, -52, and -58), in healthy girls 9–14 years of age, 24 months after vaccine administration for each study arm. 24 months post vaccination
Secondary Outcome 1. Number and proportion of participants in each study arm reporting solicited adverse events (AEs) within 30 minutes and within seven days of vaccination. 2. Number and proportion of participants in each study arm reporting unsolicited adverse events within 30 days of vaccination. 3. Number and proportion of participants in each study arm reporting serious adverse events (SAEs) throughout study duration. Solicited AEs- Within 30 minutes and 7 days post vaccination, unsolicited AEs - 30 days after vaccination and SAEs-throughout the study period
Primary Outcome IgG GMC against oncogenic HPV types (HPV-16, -18, -31, -33, -45, -52, and -58), in healthy young women 15–20 years of age, 24 months after vaccine administration for each study arm. 24 months after vaccination
Secondary Outcome IgG GMC against HPV types 6 and 11, 24 months after vaccine administration for each study arm. 24 months after vaccination
Secondary Outcome For each HPV type, seropositivity rate, seroconversion rate, IgG antibody GMC and antibody geometric mean increase from baseline, at Month 6 and Month 24 following vaccine administration (all participants) and at Month 1 and Month 12 following vaccine administration (immunogenicity subset) for each study arm. Baseline, Month 6 and Month 24 in all participants and Month 1 and Month 12 in a subset following vaccine administration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Navrongo Health Research Centre NHRC P. O. Box 114 Navrongo, Behind War Memorial Hospital, Upper East Region-Ghana Navrongo Ghana
Health Index Multispecialty Clinic HIMC Barangay Mambog 1 Bacoor City Cavite Philippines
FUNDING SOURCES
Name of source Street address City Postal code Country
Bill and Melinda Gates Foundation P. O. Box 23350 Seattle 98102 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PATH 2201 Westlake Ave, Suite 200 Seattle 98121 United States of America Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
DiagnoSearch Life Sciences Pvt. Ltd. 702, Dosti Pinnacle, E-7, Road No. 22, Wagle Industrial Estate Thane 400604 India
Xiamen INNOVAX Biotech Co. Ltd. 50 East Shanbianhong Road, Haicang District Xiamen City Fujian Province 361022 China
Navrongo Health Research Centre P. O. Box 114 Navrongo, Behind War Memorial Hospital Upper East Region-Ghana Navrongo Ghana
Health Index Multispecialty Clinic Barangay Mambog 1 Bacoor City Cavite Philippines
Frederick National Laboratory for Cancer Research Leidos Biomedical Research Inc Post Office Box B Frederick Maryland 21702 United States of America
IQVIA 2400 Ellis Rd. Durham NC 27703 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr. Nana Akosua Ansah nana.ansah@navrongo-hrc.org +233246729726 P. O. Box 114 Navrongo, Behind War Memorial Hospital
City Postal code Country Position/Affiliation
Navrongo Ghana Head of Clinical Science Department
Role Name Email Phone Street address
Principal Investigator Dr. Edison Reyes Alberto edisonalberto@rocketmail.com +639171490841 Health Index Multispecialty Clinic HIMC Barangay Mambog 1
City Postal code Country Position/Affiliation
Bacoor City Cavite Philippines Clinical Trialist
Role Name Email Phone Street address
Scientific Enquiries Nicole Grunenberg MD ngrunenberg@path.org +12062853500 2201 Westlake Avenue, Suite 200
City Postal code Country Position/Affiliation
Seattle 98121 United States of America Senior Medical Officer CVIA Clinical Functional Area
Role Name Email Phone Street address
Public Enquiries Anne Schuind MD aschuind@path.org +12028220033 455 Massachusetts Ave NW
City Postal code Country Position/Affiliation
Washington DC 20001 United States of America Initiative Team Leader for HPV Vaccines Zoonotic Emerging and Sexually Transmitted Infections
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Clinical trial results will be made publicly available in compliance with the WHO mandated timeframe for public disclosure of results from clinical trials. The results will be published on readily accessible sites with public open access and in a timely manner under the Creative Commons Attribution Generic License (CC BY 4.0) or equivalent license. Statistical Analysis Plan,Study Protocol Publications, supporting documents, and underlying de-identified data will be accessible and open immediately upon article publication. No end date. IPD underlying the published results will be accessible via a link to a data repository to be provided upon publication.
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 Actual trial start date 01/04/2025 Start date of trial at Philippines site 29 Jan 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 01/04/2025 Study initiated at both sites Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/04/2025 WCG IRB approval FALSE, WCG IRB , 212 Carnegie Center, Suite 301, Princeton, 08540, United States of America, 24 Jun 2024, , +16099450101, clientcare@wcgclinical.com, TRUE, WCG IRB , 212 Carnegie Center, Suite 301, Princeton, 08540, United States of America, 24 Jun 2024, 22 Oct 2024, +16099450101, clientcare@wcgclinical.com, 30480_29507_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/04/2025 NHRC IRB approval letter FALSE, Navrongo Health Research Centre Institutional Review Board , P.O.BOX 114, Navrongo, 0000, Ghana, 01 Jul 2024, , +233591152102, irb@navrongo-hrc.org, TRUE, Navrongo Health Research Centre Institutional Review Board , P.O.BOX 114, Navrongo, 0000, Ghana, 01 Jul 2024, 11 Oct 2024, +233591152102, irb@navrongo-hrc.org, 30480_29508_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/04/2025 UERM ERC approval letter FALSE, University of the East Ramon Magsaysay Memorial Medical Center Inc. Research Institute for Health Sciences Ethics Review Committee, Aurora Blvd. , Quezon City, 000, Philippines, 05 Jul 2024, , +6327150861, ethicsreviewcommittee@uerm.edu.ph, TRUE, University of the East Ramon Magsaysay Memorial Medical Center Inc. Research Institute for Health Sciences Ethics Review Committee, Aurora Blvd. , Quezon City, 000, Philippines, 05 Jul 2024, 15 Oct 2024, +6327150861, ethicsreviewcommittee@uerm.edu.ph, 30480_29509_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 01/04/2025 GHS ERC Approval letter FALSE, Ghana Health Service Ethics Review Committee, P. O. BOX MB 190, Accra, 0000, Ghana, 01 Jul 2024, , +233503539896, ethics.research@ghs.gov.gh, TRUE, Ghana Health Service Ethics Review Committee, P. O. BOX MB 190, Accra, 0000, Ghana, 01 Jul 2024, 30 Oct 2024, +233503539896, ethics.research@ghs.gov.gh, 30480_29511_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 05/07/2024 An additional CRO added for statistical support and regulatory support in the Philippines. IQVIA, 2400 Ellis Rd. , Durham NC, 27703 , United States of America
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/07/2024 Based on comments from trial reviewer. Summary results for primary and secondary objectives. Clinical trial results will be made publicly available in compliance with the WHO mandated timeframe for public disclosure of results from clinical trials. The results will be published on readily accessible sites with public open access and in a timely manner under the Creative Commons Attribution Generic License (CC BY 4.0) or equivalent license.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 05/07/2024 Based on comments from trial reviewer. Within 12 months of completion of study Publications, supporting documents, and underlying de-identified data will be accessible and open immediately upon article publication. No end date.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 05/07/2024 Based on comments from trial reviewer. Researchers who provide a methodologically sound proposal may be provided access after Sponsor permission. IPD underlying the published results will be accessible via a link to a data repository to be provided upon publication.