A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men

Inclusion 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