Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.

PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

OBJECTIVES:

Primary

* To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.
* To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.

Secondary

* To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.
* To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.
* To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.
* To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

* To evaluate prevalent and incident HPV infections in the anal canal.
* To evaluate cytological and histological abnormalities in the anal canal.
* To evaluate prevalent and incident HPV infections in the oral cavity.
* To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Inclusion criteria:

* HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry

  * HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
* Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
* If receiving antiretroviral therapy:

  * Receipt of antiretroviral therapy for at least 6 months prior to entry
  * No change in antiretroviral therapy within 30 days prior to entry
  * CD4 cell count \> 200 cells/mm³ within 90 days prior to study entry
  * HIV-1 RNA \< 200 copies/mL within 90 days prior to entry
* If not receiving antiretroviral therapy:

  * CD4 cell count ≥ 350 cells/mm³ within 90 days prior to study entry
  * No plans to start antiretroviral therapy prior to week 28
* Normal anal cytological result, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry

Exclusion criteria:

* Current or history of anal or perianal carcinoma
* Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results
* Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN

  * Current or history of anal or peri-anal condyloma is allowed

PATIENT CHARACTERISTICS:

Inclusion criteria:

* Karnofsky performance status 70-100%
* Absolute neutrophil count \> 750 cells/mm³
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm³
* Creatinine clearance ≥ 60 mL/min
* AST and ALT ≤ 3 times ULN
* Total or conjugated (direct) bilirubin ≤ 2.5 times ULN

Exclusion criteria:

* Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
* Serious illness requiring systemic treatment and/or hospitalization within the past 45 days
* Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
* Hemophilia

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

* See Disease Characteristics

Exclusion criteria:

* Prior splenectomy
* Currently receiving anticoagulation therapy other than acetylsalicylic acid
* Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry

  * Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
  * Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
* Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine