NCT04508309

Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls

Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,025 (actual)
• Sponsor: PATH · Academic / Other
• Sex: Female
• Age: 9 Years – 14 Years
• Healthy volunteers: Accepted

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.

Detailed description

This randomized, active-comparator controlled, open-label study will enroll total of approximately 1025 girls aged 9 to 14 years, in one country in Africa (Ghana) and one country in South/Southeast Asia (Bangladesh). Participants will be randomized 1:1:1:1:1 to receive Cecolin® at 0 and 6 months, 0 and 12 months, or 0 and 24 months, Gardasil® at 0 and 6 months, or Gardasil® at 0 months and Cecolin® at 24 months. For each arm, blood will be collected for immunologic testing at baseline and one month following second dose. Additional blood collections will occur immediately prior to the administration of the second dose, as well as at additional later time points, for immunobridging to other published and ongoing trials. The study also aims to evaluate the performance of a mixed arm (group 5) of Gardasil® followed by Cecolin® and collect data on effects of interchangeability. Girls of target age will be identified, and their parents contacted to attend an informational session for individual discussion, informed consent, assent and randomization. The study will be conducted by the research groups in International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in Bangladesh and the Malaria Research Center (MRC) in Ghana.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Cecolin®	Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine
BIOLOGICAL	Gardasil®	Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine

Timeline

• Start date: 2021-03-15
• Primary completion: 2023-12-14
• Completion: 2023-12-14
• First posted: 2020-08-11
• Last updated: 2025-01-30
• Results posted: 2025-01-30

Locations

2 sites across 2 countries: Bangladesh, Ghana