Impact of an HPV Vaccine in HIV-Infected Young Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00710593
First received: July 2, 2008
Last updated: October 26, 2012
Last verified: October 2012

July 2, 2008
October 26, 2012
February 2008
February 2011   (final data collection date for primary outcome measure)
Immunogenicity of the HPV-6, -11, -16, -18 vaccine after vaccine dose #3 as measured by the geometric mean titers to HPV-6, -11, -16, and -18. [ Time Frame: Weeks 28 and 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00710593 on ClinicalTrials.gov Archive Site
  • To determine the immunogenicity of the HPV-6, -11, -16, -18 vaccine four weeks post vaccine dose #3. [ Time Frame: Weeks 28 and 48 ] [ Designated as safety issue: No ]
  • To determine whether the HPV-6, -11, -16, -18 vaccine is well-tolerated and safe in HIV-infected young women when given in a standard dosing regimen. [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 24, Week 28, and Week 48 ] [ Designated as safety issue: Yes ]
  • To examine whether vaccine immunogenicity or safety varies as a function of subject age and/or treatment status at the time of vaccination. [ Time Frame: Day 1, Week 4, Week 8, Week 12, Week 24, Week 28, and Week 48 ] [ Designated as safety issue: Yes ]
  • Persistence of the immune response 24 weeks post vaccine dose #3. [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • The impact of vaccination on acquisition of vaccine and nonvaccine HPV types 24 and 48 weeks after initial vaccination among those who seroconvert. [ Time Frame: Weeks 24 and 28 ] [ Designated as safety issue: No ]
  • To characterize young women's risk perceptions, sexual behaviors, and STI diagnosis over the 48 weeks after initial vaccination. [ Time Frame: Day 1 through Week 48 ] [ Designated as safety issue: Yes ]
  • To compare AE reporting using a telephone response system vs. a vaccine report card. [ Time Frame: Day 1 through Week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of an 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
Biological: HPV vaccine for strains -6, -11, -16, and -18
All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
  • Active Comparator: A
    Participants who are ART naïve or, if ART-exposed, have not received HAART for at least the six months prior to study entry. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
    Intervention: Biological: HPV vaccine for strains -6, -11, -16, and -18
  • Active Comparator: B
    Participants who have 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. All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
    Intervention: Biological: HPV vaccine for strains -6, -11, -16, and -18
Kahn JA, Xu J, Kapogiannis BG, Rudy B, Gonin R, Liu N, Wilson CM, Worrell C, Squires KE. Immunogenicity and safety of the human papillomavirus 6, 11, 16, 18 vaccine in HIV-infected young women. Clin Infect Dis. 2013 Sep;57(5):735-44. doi: 10.1093/cid/cit319. Epub 2013 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
February 2011
February 2011   (final data collection date for primary outcome measure)

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 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 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 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 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
Female
16 Years to 23 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00710593
ATN 064
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Study Chair: Jessica A. Kahn, M.D., M.P.H. Adolescent Trials Network
Study Chair: Kathleen Squires, M.D. Adolescent Trials Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP