drugset / Trial / NCT04508309
Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls
Phase 3
Completed
1025 enrolled
PATH
Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA · collabInternational Centre for Diarrhoeal Disease Research, Bangladesh · collabMalaria Research Centre, Agogo Presbyterian Hospital, Ghana · collabThe Emmes Company, LLC · collabXiamen Innovax Biotech Co., Ltd · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
This randomized controlled trial will evaluate a bivalent HPV vaccine, Cecolin®, in alternate 2-dose regimens, compared to an established HPV vaccine. Gardasil® will be used as the comparator vaccine, as this vaccine is most widely used in low- and low-middle income countries.
Timeline
- Start
- 2021-03-15
- Primary completion
- 2023-12-14
- Completion
- 2023-12-14
Outcome
Met primary endpoint
paper 1 month after the second dose, 2vHPV non-inferiority was shown PMID 40120597 ↗
paper between 1·3 and 1·7 (1·0 and 1·4) for HPV-18 PMID 40120597 ↗
Publications
- Results Zaman K, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PB, Qadri F, Kemp TJ, Hossain L, Pinto LA, Sukraw K, Bhat N, Agbenyega T. Safety and immunogenicity of Innovax bivalent human papillomavirus vaccine in girls 9-14 years of age: Interim analysis from a phase 3 clinical trial. Vaccine. 2024 Apr 2;42(9):2290-2298. doi: 10.1016/j.vaccine.2024.02.077. Epub 2024 Mar 1.
- Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
- Agbenyega T, Schuind AE, Adjei S, Antony K, Aponte JJ, Buabeng PBY, Clemens JD, Hossain L, Kemp TJ, Mercer LD, Pinto LA, Qadri F, Sukraw K, Bhat N, Zaman K. Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: a randomised, controlled, open-label, non-inferiority, phase 3 trial. Lancet Infect Dis. 2025 Aug;25(8):861-872. doi: 10.1016/S1473-3099(25)00031-3. Epub 2025 Mar 19.