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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710593
First Posted: July 4, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
July 2, 2008
July 4, 2008
November 15, 2013
May 22, 2017
July 2, 2017
February 2008
February 2011   (Final data collection date for primary outcome measure)
  • HPV-6 Antibody Level (Geometric Mean Titer of HPV-6) [ Time Frame: Week 28 ]
    The outcome measure for the primary objective is immunogenicity as measured by the GMT of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.
  • HPV-11 Antibody Level (Geometric Mean Titer of HPV-11) [ Time Frame: Week 28 ]
    The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine Dose #3 was administered at Week 24.
  • HPV-16 Antibody Level (Geometric Mean Titer of HPV-16) [ Time Frame: Week 28 ]
    The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24.
  • HPV-18 Antibody Level (Geometric Mean Titer of HPV-18) [ Time Frame: Week 28 ]
    The outcome measure for the primary objective is immunogenicity as measured by the GMTs of HPV-6, -11, -16, -18 vaccine four weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.
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 ]
Complete list of historical versions of study NCT00710593 on ClinicalTrials.gov Archive Site
  • Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-6 [ Time Frame: Week 28 ]
    Subjects who had a greater than or equal to (>=) 20 Milli-Merck units (mMU)/milliliter (mL) response were classified as responders; subjects who had a less than (<) 20 mMU/mL response were classified as non-responders.
  • Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-11 [ Time Frame: Week 28 ]
    Subjects who had a >= 16 mMU/mL were classified as responders; subjects who had a less than < 16 mMU/mL response were classified as non-responders.
  • Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-16 [ Time Frame: Week 28 ]
    Subjects who had a >= 20 mMU/mL were classified as responders; subjects who had a less than < 20 mMU/mL response were classified as non-responders.
  • Immunogenicity of the HPV-6, -11, -16, -18 Vaccine Four Weeks After Vaccine Dose #3 as Measured as a Binary Variable (Responder vs. Non-responder) for HPV-18 [ Time Frame: Week 28 ]
    Subjects who had a >= 24 mMU/mL were classified as responders; subjects who had a less than < 24 mMU/mL response were classified as non-responders.
  • Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine [ Time Frame: Entry, Week 8, and Week 24 ]
    When a subject had at least one adverse event or sign/symptom during the study after doses 1, 2 or 3, and the event was possibly, probably, or definitely related to vaccine, this subject was considered to have had a vaccine-associated adverse event, sign and/or symptom.
  • Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-6. [ Time Frame: Week 48 ]
    Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose #3 was administered at Week 24.
  • Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-11. [ Time Frame: Week 48 ]
    Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24
  • Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-16. [ Time Frame: Week 48 ]
    Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24
  • Persistence of Immunogenicity of the HPV-6, -11, -16, and -18 Vaccine 24 Weeks Post Vaccine Dose #3 as Measured by the Geometric Mean Titers (GMT) of HPV-18. [ Time Frame: Week 48 ]
    Persistence of immunogenicity as measured by geometric mean titers (GMT) to HPV-6, -11, -16, -18 vaccine 24 weeks after the administration of vaccine dose #3, measured as a continuous variable. Vaccine dose # 3 was administered at Week 24
  • Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24). [ Time Frame: Week 24 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-6 sero-negative by study group and study visit at Week 24.
  • Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24). [ Time Frame: Week 24 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-11 sero-negative by study group and study visit at Week 24.
  • Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24). [ Time Frame: Week 24 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-16 sero-negative by study group and study visit at Week 24.
  • Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24). [ Time Frame: Week 24 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV-18 sero-negative by study group and study visit at Week 24.
  • Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48). [ Time Frame: Week 48 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
  • Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48). [ Time Frame: Week 48 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
  • Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48). [ Time Frame: Week 48 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
  • Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48). [ Time Frame: Week 48 ]
    Type-specific HPV DNA among subjects who were both HPV DNA negative and HPV sero-negative by study group and study visit at Week 48.
  • Percentage of Participants Who Reported a Lower Need to Practice Safe Sex Following HPV Vaccination and the Percentage of Participants That Reported a Higher Need to Practice Safe Sex Following HPV Vaccination [ Time Frame: Week 48 ]

    Participants' perceptions for the need to practice safe sex following HPV vaccination was measured using a safer sexual behaviors subscale, which was comprised of the following five questions:

    After getting vaccinated against HPV …

    1. You feel that condom use during sex is less necessary.
    2. You feel it is still just as important to have as few sexual partners as possible.
    3. You feel that it is less important to talk to your sex partners about safe sex.
    4. You think it is still just as important to use a condom every time you have sex.
    5. You will be less worried about having unprotected sex. Those who were categorized in the "lower need for safer sexual behaviors (NSSB)" group had a summary score that was less than the median and those in the "higher NSSB" group had a summary score that was equal to or higher than the median.
  • Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure) [ Time Frame: Week 48 ]
    To characterize young women's risk perceptions, sexual behaviors, and sexually transmitted infections (STI) diagnoses over the 48 weeks after initial vaccination, the relationship of baseline "12-item Knowledge About HPV and HPV Vaccine" measure was used to evaluate the need for safer sexual behaviors.
  • Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card. [ Time Frame: Day 1 through Week 24 ]
    Visit compliance is the total number of days participants actually called the TRS or completed the VRC divided by the total number of days expected to call the TRS or complete the VRC, multiplied by 100%.
  • Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC). [ Time Frame: Day 1 through Week 24 ]
    Rate of AEs is the total number of AEs divided by the total number of participants. The rate is not a percentage bur rather it could be above 1 or less than 1. This outcome measure looked at number of AEs reported, by grade; number of AEs > Grade 3 identified; and number of AEs > Grade 3 evaluated within 24 or 48 hours.
  • To determine the immunogenicity of the HPV-6, -11, -16, -18 vaccine four weeks post vaccine dose #3. [ Time Frame: Weeks 28 and 48 ]
  • 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 ]
  • 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 ]
  • Persistence of the immune response 24 weeks post vaccine dose #3. [ Time Frame: Week 48 ]
  • 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 ]
  • 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 ]
  • To compare AE reporting using a telephone response system vs. a vaccine report card. [ Time Frame: Day 1 through Week 48 ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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: HAART naive or no HAART in past 6 months
    Participants who are ART naïve or, if ART-exposed, have not received highly active antiretroviral therapy (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: HAART atleast 6 months/ 2 viral loads <400 in last 6 months
    Participants who have been receiving highly active antiretroviral therapy (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

*   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 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
Sexes Eligible for Study: Female
16 Years to 23 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00710593
ATN 064
Yes
Not Provided
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Study Chair: Jessica A. Kahn, M.D., M.P.H. Adolescent Trials Network
Study Chair: Kathleen Squires, M.D. Adolescent Trials Network
University of North Carolina, Chapel Hill
April 2017

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