Safety of and Immune Response to the Human Papillomavirus (HPV) Vaccine in HIV-Infected Women
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Intervention: Quadrivalent HPV vaccine
Intervention description: Quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine. All participants received the vaccine via intramuscular injection at baseline, Week 8 and Week 24.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 319.0
Sex: Female
Minimum age: 13 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: HIV; HPV 6; HPV 11; HPV 16; HPV 18; Vaccine

Summary:

      Human papillomavirus (HPV) is the most common sexually transmitted disease in the world. HPV
      infection can cause genital warts and certain cervical problems, including cervical cancer.
      HPV infection may be more severe and harder to treat in HIV-infected people. The purpose of
      this study was to determine whether the quadrivalent HPV vaccine is safe, tolerable, and
      effective in producing antibodies to HPV in HIV-infected women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection

          -  CD4 count obtained within 45 days prior to study entry

          -  Karnofsky performance score >=70 on at least one occasion within 45 days prior to
             study entry

          -  The following labs within 45 days prior to study entry:

               -  hemoglobin >8.0 g/dL

               -  direct bilirubin <2.5 x upper limit of normal (ULN)

               -  alanine aminotransferase, ALT (SGPT) <3 xULN

               -  aspartate aminotransferase, AST (SGOT) <3 xULN

               -  platelet count >=100,000 /mm^3

          -  Willing to use acceptable forms of contraception for the duration of the study

          -  Written informed consent from participant or from parent or guardian, if applicable

          -  If on HAART, then the same regimen for at least 12 weeks prior to study entry with no
             change within 30 days prior to study entry. (This criterion was removed in Version 2.0
             of the protocol.)

          -  HIV viral load obtained within 45 days prior to study entry (This criterion was
             removed in Version 2.0 of the protocol.)

        Exclusion Criteria:

          -  Abnormal Pap test with confirmed biopsy results of cervical intraepithelial neoplasia
             (CIN) II or III or cervical cancer within 180 days prior to study entry

          -  Vulval intraepithelial neoplasia (VIN) II or III or cancer confirmed by biopsy results
             within 180 days prior to study entry

          -  Physician-diagnosed genital warts within 180 days prior to study entry

          -  Previous cervical dysplasia treatment, including loop electrosurgical excision
             procedure (LEEP), cervical cryotherapy, cone biopsy, and cervical laser vaporization
             within 180 days prior to study entry

          -  Use of any systemic antineoplastic or immunomodulatory treatment, systemic
             corticosteroids, investigational vaccines, interleukins, interferons, growth factors,
             or intravenous immunoglobulin (IVIG) within 45 days prior to study entry. Participants
             who had received standard of care (e.g., hepatitis B, influenza, and tetanus) vaccines
             were not excluded.

          -  Known allergy or hypersensitivity to yeast or any components of the vaccine or its
             formulation

          -  Current drug or alcohol use or dependence or any other condition that may interfere
             with study participation

          -  Serious illness requiring systemic treatment and/or hospitalization within 45 days
             prior to study entry

          -  Total hysterectomy. Participants who had undergone partial hysterectomy and had a
             cervix were not excluded.

          -  Hemophilia

          -  Currently on anticoagulation therapy other than acetylsalicylic acid

          -  Prior vaccination with an HPV vaccine

          -  Pregnant or breastfeeding