NCT06281119

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Phase-3b, partially double-blind, randomized, multi-country study to assess the immunogenicity, safety, and reactogenicity of SIIPL qHPV vaccine in WLWH aged 15-25 years. A total of 450 subjects will be enrolled in the study such that 150 subjects in each group receive either 3-doses of SIIPL qHPV vaccine, 2-doses of SIIPL qHPV vaccine or 3-doses of Gardasil®. Subjects will be randomized in a 1:1:1 ratio to a 2-dose or 3-dose schedule of SIIPL qHPV vaccine or 3-dose schedule of Gardasil®. This study is designed as a partially double-blind, randomized study with a primary objective to compare the immunogenicity of the 3-dose schedule of SIIPL qHPV vaccine versus a 3-dose schedule of Gardasil®. The secondary objectives include comparison in the immune response between WLWH receiving 2-dose schedule of SIIPL qHPV vaccine and a 3-dose schedule of SIIPL qHPV. The immunogenicity data will be collected up to Month 12 and data at 7-month will be considered for analysis of primary immunogenicity endpoints.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-02-28
• Last updated: 2025-01-07

Locations

4 sites across 3 countries: Kenya, Mozambique, South Africa