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

Prior treatment

• Known history of prior vaccination with HPV vaccine.
• Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
• Current diagnosis or prior history of genital warts or treatment of genital warts.
• Presence of an acute illness and/or fever at the time of vaccination or during the 72 hours prior to the vaccination.
• Presence of active tuberculosis or currently on TB therapy.
• History of receiving a blood transfusion or other blood products in three months prior to screening.

Other illness

• Current diagnosis or history of treatment for cervical pre malignancies or malignancies.
• History of any allergic diseases or severe allergic reaction to any agent.
• Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate intramuscular injection.
• History of major congenital defects or illness that requires medical therapy, as determined by medical history or clinical assessment.
• History of chronic administration of high doses of corticosteroids, cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
• History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
• History of any cancer, organ transplant or any other immune system disease (other than HIV/AIDs).

Other

• Pregnant females.
• Subject or subject's parent, is or has an immediate family member who is study specific site staff directly involved with this trial.

• Women Living with HIV aged 15-25 years at the time of screening
• Subjects with age 18 years and above, should be willing and able to provide written informed consent while for subjects \<18\*years of age, parents willing to provide written informed consent and subject is willing to sign written assent form for participation prior to initiating any study related procedure.
• Subject or parent willing to comply with all study requirements.
• Subjects who are determined by medical history, physical examination and clinical judgment of the Investigator to be eligible for inclusion in the study.
• Women of childbearing potential (WOCBP) (sexually active/ ≥18 years of age) must meet 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 have abstained from all activities that could result in pregnancy from the time of screening up to first vaccine administration (Day 0).
  • Have a negative Urine Pregnancy Test (UPT) at screening and on the day of vaccination (Day 0).
  • Have agreed to continue effective contraception during the entire treatment period and for two months after completion of the vaccination series.
• Subject must be asymptomatic (or only have persistent generalized lymphadenopathy) regardless of prior clinical stage.
• If the subjects were currently taking antiretroviral (ARV) therapy, subjects were to be on highly active antiretroviral therapy (HAART), have undetectable viral load reported at least six months prior, and have a CD4+ cell count \>350 cells/mm3 at study entry.
• If the subjects are not on HAART, subjects should have a CD4+ cell count \> 350 cells/mm3 at study entry.