nctId: NCT06281119 id: SII-qHPV/MC-03 briefTitle: Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-05 date: 2024-02-28 date: 2024-02-28 name: Serum Institute of India Pvt. Ltd. class: INDUSTRY name: Bill and Melinda Gates Foundation briefSummary: 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 studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Cervavac as three dose regimen name: Cervavac as two dose regimen name: Gardasil as three dose regimen measure: Geometric mean titers of anti HPV 16 and 18 IgG antibodies measure: Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion measure: Adverse Events measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion measure: Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage measure: CD4+ cell count, HIV viral load, and HIV clinical staging sex: FEMALE minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Centre For Clinical Research, Kemri city: Nairobi zip: 54840-00200 country: Kenya name: Nelly Mugo role: CONTACT phone: +254733629665 email: rwamba@uw.edu lat: -1.28333 lon: 36.81667 facility: Partners in Health and Research Development (Phrd) city: Thika zip: 19865-00202 country: Kenya name: Nelly Mugo role: CONTACT phone: +254733629665 email: rwamba@uw.edu lat: -1.03326 lon: 37.06933 facility: Manhiça Health Research Center - Manhiça Foundation (CISM-FM) city: Manhiça zip: 1929 country: Mozambique name: Tacilta Nhampossa role: CONTACT phone: +258 21 810 181 email: tacilta.nhampossa@manhica.net facility: Clinical HIV Research Unit (CHRU), Helen Joseph Hospital city: Johannesburg zip: 2092 country: South Africa name: Carla Chibwesha role: CONTACT phone: +27 072 744 7899 email: carla_chibwesha@med.unc.edu lat: -26.20227 lon: 28.04363 hasResults: False