- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01489527
Preparedness Study - HPV Vaccine
Preparedness Study: Efficacy of HPV Vaccine to Reduce HIV Infection
Moffitt Cancer Center is the Coordinating Center for this study.
The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence.
The specific aims of this study are to:
- Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 [Gardasil]) or placebo vaccine.
- Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection.
- Assess the rate of compliance through the 3-dose vaccination series
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence
- HIV negative
- has ever had vaginal intercourse
- has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results
- fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent
- agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that include collection of cervical specimens
- agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period.
- Informed consent procedures for females <18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will include information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed.
Exclusion Criteria:
- have a history of severe allergic reaction
- have a known allergy to any vaccine component (e.g., aluminum, yeast, or BENZONASE)
- are currently immuno-compromised
- have received a marketed HPV vaccine, or are pregnant and lactating
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Gardasil Vaccine Administration
Gardasil Vaccine Administration.
Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit.
A single participant could not be assigned more than 1 allocation number.
|
The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6.
All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
다른 이름들:
|
위약 비교기: Placebo Administration
Placebo Administration.
Family Health International (FHI) statisticians randomly assigned each participant an allocation number and then subsequently assigned a unique vial identification number for the vial of vaccine the participant should receive at each visit.
A single participant could not be assigned more than 1 allocation number.
|
The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6.
All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Human Papillomavirus (HPV) Rate
기간: At Enrollment - 5 Month Enrollment Period
|
HPV type distribution and prevalence of each HPV type at enrollment.
|
At Enrollment - 5 Month Enrollment Period
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Study Compliance Rate
기간: 18 Months
|
Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.
|
18 Months
|
Percentage of Participants Who Were Seropositive by HPV Type
기간: At Enrollment - 5 Month Enrollment Period
|
Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.
|
At Enrollment - 5 Month Enrollment Period
|
Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18
기간: 18 Months
|
Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.
|
18 Months
|
Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58
기간: 18 Months
|
The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.
|
18 Months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anna Giuliano, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
간행물 및 유용한 링크
일반 간행물
- Menezes LJ, Pokharel U, Sudenga SL, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim van der Loeff MF, van der Laan LE, Kipping S, Taylor D, Giuliano AR. Patterns of prevalent HPV and STI co-infections and associated factors among HIV-negative young Western Cape, South African women: the EVRI trial. Sex Transm Infect. 2018 Feb;94(1):55-61. doi: 10.1136/sextrans-2016-053046. Epub 2017 May 10.
- Sudenga SL, Torres BN, Botha MH, Zeier M, Abrahamsen ME, Glashoff RH, Engelbrecht S, Schim Van der Loeff MF, Van der Laan LE, Kipping S, Taylor D, Giuliano AR. HPV SEROSTATUS PRE- AND POST-VACCINATION IN A RANDOMIZED PHASE II PREPAREDNESS TRIAL AMONG YOUNG WESTERN CAPE, SOUTH AFRICAN WOMEN: THE EVRI TRIAL. Papillomavirus Res. 2017 Jun;3:50-56. doi: 10.1016/j.pvr.2017.02.001. Epub 2017 Feb 16.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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