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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
Cervavac manufactured by Serum Institute of India Pvt Ltd administered as three doses at day 0, 60 and 180.
Cervavac manufactured by Serum Institute of India Pvt Ltd administered as two doses at day 0 and 180.
Gardasil manufactured by MSD administered as a three doses at day 0,60 and 180.
Centre For Clinical Research, Kemri
Nairobi, Kenya
Partners in Health and Research Development (Phrd)
Thika, Kenya
Manhiça Health Research Center - Manhiça Foundation (CISM-FM)
Manhiça, Mozambique
Clinical HIV Research Unit (CHRU), Helen Joseph Hospital
Johannesburg, South Africa
Geometric mean titers of anti HPV 16 and 18 IgG antibodies
GMTs of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV and 3 doses of Gardasil®
Time frame: at 1 month after the last dose
Immune response (Geometric mean titers) of anti HPV 6 and 11 IgG antibodies
Geometric mean titers of anti HPV 6 and 11 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV or Gardasil
Time frame: at 1 month after the last dose
Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion
Geometric mean titers of anti HPV 6, 11, 16 and 18 IgG antibodies and Pecentage seroconversion in WLWH receiving 2 doses or 3 doses of SIIPL qHPV or 3 doses of Gardasil
Time frame: at 1 month after the last dose
Adverse Events
Incidence, severity, and relationship of local and systemic solicited AEs up to 7 days following each vaccination. Incidence, severity, and relationship of unsolicited AEs from Day 0 through Month 7 and Month 12. Incidence, severity, and relationship of SAEs from Day 0 through Month 7 and Month 12.
Time frame: solicited AEs up to 7 days following each vaccination, unsolicited AEs from Day 0 through Month 7 and Month12 and SAEs from Day 0 through Month 7 and Month 12.
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