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Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 2026 to Dec 31, 2026v4 Show 4 more changesShow less
    • Start date changed from estimate of Mar 2025 to Oct 3, 2025
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2026 to Dec 31, 2027
    • Site contacts updated at 4 of 4 sites
  2. Start date: Jun 2024 to Mar 2025
    • Primary completion date: Dec 2025 to Jun 2026
    • Study completion date: May 2026 to Dec 2026
    v3
  3. Interventions: HPV Vaccine (Biological) to Cervavac as three dose regimen (Biological), Cervavac as two dose regimen (Biological), Gardasil as three dose regimen (Biological)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06281119
Lead Sponsor Serum Institute of India Pvt. Ltd.
Collaborators: Bill and Melinda Gates Foundation
Conditions
(from sponsor)		 Human Papillomavirus Infection
Related terms Papillomavirus Infections
Enrollment 450 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov