Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women

Immunogenicity, Safety, Tolerability, and Behavioral Consequences of an HPV-6, -11, -16, -18 Vaccine in HIV-Infected Young Women

The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.

Inclusion Criteria:

• Young women age 16 years and 0 days to 23 years and 364 days
• HIV-infection after the age of 9 years as documented by a positive result on any of the following licensed tests: any antibody test confirmed by Western blot, HIV-1 culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA > 1,000 copies/ml
• HIV treatment history that falls in one of the following categories:

Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months prior to study entry Group B: Has been receiving HAART for at least six months at the time of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous clinical visits within the 6 months prior to study entry

• Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects of child-bearing potential, i.e., use of at least one barrier or hormonal method; e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral (ARV) medications must use a barrier contraceptive method because ARV medications can make hormonal birth control less effective.
• Anticipated ability and willingness to complete all study vaccines and evaluations
• Ability and willingness to participate in the study by providing written informed consent

Exclusion Criteria:

• History of any prior vaccination with an HPV vaccine
• Active anogenital warts within three months prior to study entry) or history of cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)
• Previous allergic reaction to any constituents of the HPV vaccine
• Pregnancy
• Active substance use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study
• Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the time of study entry
• Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for definition of isolated total hyperbilirubinemia).
• Receipt of any routine vaccine within four weeks prior to study entry
• Receipt of any immune globulin or plasma product within six months prior study entry
• Receipt of any blood product or transfusion, other than immune globulin or plasma as noted above, within four weeks prior to study entry
• Receipt of any restricted medication listed in Section 5.3.2 within the four weeks preceding study entry
• Receipt of any other disallowed medication listed in Section 5.3.3 within the three months preceding study entry
• Thrombocytopenia or coagulation disorder that would contraindicate intramuscular injection
• Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of prednisone or equivalent for > 2 consecutive weeks)
• Receipt of corticosteroid therapy at the above dose and duration within 3 months preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or topical corticosteroids are not exclusion criteria
• Known or suspected disease of the immune system (other than HIV), i.e., malignancy, current or prior treatment for malignancy
• If other serious, acute or chronic medical or surgical conditions or contraindications are present during screening, the Protocol Team must be consulted to determine whether enrollment may interfere with the evaluation of the protocol objectives and for permission to proceed with the enrollment