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A Phase-3b, Partially Double-blind, Randomized, Multi-country Clinical Study to Evaluate the Immunogenicity,safety, and Reactogenicity of SIIPL QHPV Vaccine (CERVAVAC®) in Women Living with HIV Aged 15-25 Years
Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.
Details
| Lead sponsor | Serum Institute of India Pvt. Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 450 |
| Start date | 2025-03 |
| Completion | 2026-12 |
Conditions
- Human Papillomavirus Infection
Interventions
- Cervavac as three dose regimen
- Cervavac as two dose regimen
- Gardasil as three dose regimen
Primary outcomes
- Geometric mean titers of anti HPV 16 and 18 IgG antibodies — at 1 month after the last dose
GMTs of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV and 3 doses of Gardasil®
Countries
Kenya, Mozambique, South Africa