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

NCT06281119 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2025-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Human Papillomavirus Infection

Interventions

BIOLOGICAL

Cervavac as three dose regimen

Cervavac manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180.

BIOLOGICAL

Cervavac as two dose regimen

Cervavac manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180.

BIOLOGICAL

Gardasil as three dose regimen

Gardasil manufactured by MSD administered as a three doses at day 0,60 and 180.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Carla Chibwesha · Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South Africa

  • Nelly Mugo · CCR, KEMRI, Nairobi-Kenya & PHRD, Thika-Kenya

  • Tacilta Nhampossa · Manhiça Health Research Center - Manhiça Foundation,Manhiça

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Kenya
  • Mozambique
  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06281119 on ClinicalTrials.gov