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

2017년 6월 1일 업데이트: University of North Carolina, Chapel Hill

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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

99

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90027
        • Childrens Hospital of Los Angeles
    • District of Columbia
      • Washington, D.C., District of Columbia, 미국, 20010
        • Childrens National Medical Center
    • Florida
      • Fort Lauderdale, Florida, 미국, 33316
        • Childrens Diagnostic & Treatment Center
      • Miami, Florida, 미국, 33101
        • University of Miami School of Medicine
      • Tampa, Florida, 미국, 33606
        • USF College of Medicine
    • Illinois
      • Chicago, Illinois, 미국, 60614
        • Childrens Memorial Hospital
      • Chicago, Illinois, 미국, 60612
        • Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
    • Louisiana
      • New Orleans, Louisiana, 미국, 70112
        • Tulane University Health Sciences Center
    • Maryland
      • Baltimore, Maryland, 미국, 21201
        • University of Maryland
    • New York
      • New York, New York, 미국, 10128
        • Mount Sinai Medical Center
      • The Bronx, New York, 미국, 10467
        • Montefiore Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
        • Childrens Hospital of Philadelphia
    • Tennessee
      • Memphis, Tennessee, 미국, 38105
        • St Jude Childrens Research Hospital
  • 푸에르토 리코
      • San Juan, 푸에르토 리코, 00936-5067
        • University of Puerto Rico, Medical Sciences Campus

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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).
생물학적: 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).
활성 비교기: 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).
생물학적: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
HPV-6 Antibody Level (Geometric Mean Titer of HPV-6)
기간: 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.
Week 28
HPV-11 Antibody Level (Geometric Mean Titer of HPV-11)
기간: 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.
Week 28
HPV-16 Antibody Level (Geometric Mean Titer of HPV-16)
기간: 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.
Week 28
HPV-18 Antibody Level (Geometric Mean Titer of HPV-18)
기간: 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.
Week 28

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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.
Week 28
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
기간: 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.
Week 28
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
기간: 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.
Week 28
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
기간: 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.
Week 28
Number of Participants With At Least One Adverse Event Possibly, Probably, or Definitely Related to Vaccine
기간: 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.
Entry, Week 8, and 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-6.
기간: 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.
Week 48
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.
기간: 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
Week 48
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.
기간: 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
Week 48
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.
기간: 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
Week 48
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 24).
기간: 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.
Week 24
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 24).
기간: 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.
Week 24
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 24).
기간: 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.
Week 24
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 24).
기간: 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.
Week 24
Acquisition of HPV-6 DNA by Study Group and Study Visit (Week 48).
기간: 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.
Week 48
Acquisition of HPV-11 DNA by Study Group and Study Visit (Week 48).
기간: 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.
Week 48
Acquisition of HPV-16 DNA by Study Group and Study Visit (Week 48).
기간: 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.
Week 48
Acquisition of HPV-18 DNA by Study Group and Study Visit (Week 48).
기간: 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.
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
기간: 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.
Week 48
Need for Safer Sexual Behaviors (NSSB) (Evaluated by Using the "12-item Knowledge About HPV and HPV Vaccine" Measure)
기간: 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.
Week 48
Visit Compliance Via the Telephone Response System (TRS) Versus the Vaccine Report Card.
기간: 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%.
Day 1 through Week 24
Adverse Events (AE) Reported Among Participants Who Were Randomized to the Telephone Response System (TRS) or Vaccine Report Card (VRC).
기간: 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.
Day 1 through Week 24

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of North Carolina, Chapel Hill

수사관

  • 연구 의자: Jessica A. Kahn, M.D., M.P.H., Adolescent Trials Network
  • 연구 의자: Kathleen Squires, M.D., Adolescent Trials Network

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2008년 2월 1일

기본 완료 (실제)

2011년 2월 1일

연구 완료 (실제)

2011년 2월 1일

연구 등록 날짜

최초 제출

2008년 7월 2일

QC 기준을 충족하는 최초 제출

2008년 7월 2일

처음 게시됨 (추정)

2008년 7월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 6월 1일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ATN 064

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다