Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. The main burden of HPV-related disease is due to cervical cancer. A large majority of cervical cancer (more than 95%) is due to the human papillomavirus (HPV). Cervical Cancer is the fourth most common cancer among females worldwide and the fourth most common cause for female cancer deaths. Cervical cancer is the second most prevalent cancer among females aged 15 to 44 years. 

Infection by certain HPV types have also been reported to be associated with head and neck cancers, with oropharyngeal cancer in both men and women. 

HPV can easily spread through direct skin to skin contact or any kind of genital contact during sexual activity. Most of those infected with HPV do not develop clinical disease or symptoms because the body’s immune system resolves most infections with about 90% clearing within 2 years. A small number of those infected with certain types of HPV can persist and progress to cancer. These are classified as high-risk HPV types. Women Living with HIV have a higher chance of being infected with HPV and getting cervical cancer than HIV-negative women. 

Cervical cancer is one of the most preventable and treatable of all cancers. Cervical cancer screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. The arrival of HPV vaccines has brought in hopes of complete eradication of cervical cancer. The Cervavac® vaccine is a new vaccine that has been produced by the Serum institute of India. 

This study will be conducted among women living with HIV aged 15 years to 20 years. One group of women will receive 2 doses of the Cervavac® vaccine, the second group of women will receive 3 doses of the Cervavac® vaccine, and the third group of women will receive a Gardasil® vaccine. 

The main of this study is to compare the immune response to HPV types 16 and 18 in women living with HIV between those who will receive 2 doses and those who receive 3 doses of the Cervavac® vaccine.

HPV infection may be completely asymptomatic or may induce benign proliferative disorders, such as skin warts, laryngeal papilloma and genital warts or can also be oncogenic. 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. Cancer of the cervix uteri is the fourth most common cancer among females worldwide and the fourth most common cause for female cancer deaths with an estimated 90% of the new cases and deaths worldwide in 2020 occurring in low- and middle-income countries. Women  Living with HIV have higher HPV prevalence and cervical cancer incidence than HIV-negative women, partly due to HIV’s modifying effect on HPV pathogenesis. 

This is a Phase-3b, partially double-blind, randomized, multi-country study to assess the immunogenicity, safety, and reactogenicity of SIIPL qHPV vaccine in women living with HIV 157 aged 15-25 years. 

The primary objective of this study is to compare immune response (GMT) to HPV types 16 & 18 between Women living with HIV (WLHV) receiving 3 doses of SIIPL qHPV and 3 doses of 160 Gardasil® at Month 7 (1 month after the last dose). A total of 450 women will be enrolled in the study such that 150 study participants in each group receive either 3-doses of SIIPL qHPV vaccine, 2-doses of SIIPL qHPV vaccine or 3-doses of Gardasil®. 

This study will be conducted in women living with HIV (WLWH) aged 15-25 years. A total of 450 WLWH subjects, who fulfill all eligibility criteria will be randomized in a 1:1:1 ratio so that 150 subjects in each group receive either 3 doses (Day 0, 60 and 180) or 2 doses (Day 0 and Day 166 180) of SIIPL qHPV vaccine or 3 doses (Day 0, 60 and 180) of the comparator Gardasil® vaccine. 

The primary endpoint for the study is to look at Geometric mean titers of anti HPV 16 and 18 IgG antibodies in WLWH receiving 3 doses of SIIPL qHPV vaccine or Gardasil® vaccine, at Month 7.