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