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

Inclusion Criteria:

1. Women Living with HIV aged 15-25 years at the time of screening

2. Subjects with age 18 years and above, should be willing and able to provide writteninformed consent while for subjects <18*years of age, parents willing to providewritten informed consent and subject is willing to sign written assent form forparticipation prior to initiating any study related procedure.

3. Subject or parent willing to comply with all study requirements.

4. Subjects who are determined by medical history, physical examination and clinicaljudgment of the Investigator to be eligible for inclusion in the study.

5. Women of childbearing potential (WOCBP) (sexually active/ ≥18 years of age) mustmeet all the following criteria: Have practiced effective contraception (such as any one of the following: oral,transdermal, injectable or implanted contraceptive; condoms; occlusive cap [diaphragm or cervical vault caps]; spermicidal foam/gel/cream, etc.) or haveabstained from all activities that could result in pregnancy from the time ofscreening up to first vaccine administration (Day 0). Have a negative Urine Pregnancy Test (UPT) at screening and on the day ofvaccination (Day 0). Have agreed to continue effective contraception during the entire treatment periodand for two months after completion of the vaccination series.

6. Subject must be asymptomatic (or only have persistent generalized lymphadenopathy)regardless of prior clinical stage.

7. If the subjects were currently taking antiretroviral (ARV) therapy, subjects were tobe on highly active antiretroviral therapy (HAART), have undetectable viral loadreported at least six months prior, and have a CD4+ cell count >350 cells/mm3 atstudy entry.

8. If the subjects are not on HAART, subjects should have a CD4+ cell count > 350cells/mm3 at study entry.

Exclusion Criteria:

1. Known history of prior vaccination with HPV vaccine.

2. Concurrently enrolled in clinical studies of investigational agents or studiesinvolving collection of cervical/genital specimens.

3. Current diagnosis or prior history of genital warts or treatment of genital warts.

4. Current diagnosis or history of treatment for cervical pre malignancies ormalignancies.

5. Pregnant females.

6. History of any allergic diseases or severe allergic reaction to any agent.

7. Presence of an acute illness and/or fever at the time of vaccination or during the 72 hours prior to the vaccination.

8. Presence of active tuberculosis or currently on TB therapy.

9. Bleeding diathesis or uncontrolled condition associated with prolonged bleeding thatwould, in the opinion of the Investigator, contraindicate intramuscular injection.

10. History of major congenital defects or illness that requires medical therapy, asdetermined by medical history or clinical assessment.

11. History of chronic administration of high doses of corticosteroids, cytotoxic agentsor radiotherapy or immunoglobulins, immunosuppressants or other immune-modifyingdrugs in last 3 months or planned at any time during the study.

12. History of receiving a blood transfusion or other blood products in three monthsprior to screening.

13. History of any major pulmonary, cardiovascular, renal, neurological, metabolic,gastro-intestinal, hepato-biliary, hematological functional abnormality, mental orphysical disability, blood dyscrasia or any condition which in the opinion of theinvestigator might interfere with the evaluation of the study objectives.

14. History of any cancer, organ transplant or any other immune system disease (otherthan HIV/AIDs).

15. Subject or subject's parent, is or has an immediate family member who is studyspecific site staff directly involved with this trial.