- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00888446
Safety and Immunogenicity Study of tgAAC09, an HIV Vaccine in an Adeno-associated Virus (AAV) Capsid (TGC14F)
Phase II, Placebo-controlled, Double-blind, Dose-escalation/Dose-optimization Trial to Evaluate Safety and Immunogenicity of tgAAC09, an HIV Vaccine Containing Clade C Gag-PR-ΔRT DNA in an Adeno-associated Virus (AAV) Capsid
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Healthy male or female
- Age at least 18 years on the day of screening and no greater than 50 years on the day of the first study injection
- Willing to comply with the requirements of the protocol and available for follow up for the planned duration of the study
- Able and willing to give informed consent.
- Willing to undergo HIV testing, counseling and receive results
- If sexually active female of child-bearing potential (not menopausal or anatomically sterile), willing to use an effective method of contraception (hormonal contraceptives; intrauterine contraceptive device (IUCD); condoms; anatomical sterility in self or partner) from screening until at least four months after last study injection and willing to undergo urine pregnancy tests at screening, prior to each injection and four months after the last injection
- If sexually active male, willing to use a method of contraception (such as condoms) from screening until four months after the last study injection
Exclusion Criteria:
- HIV-1 or HIV-2 infection
- Active tuberculosis
- Clinically relevant abnormality on history or examination including history of immunodeficiency, or cancer, or autoimmune disorder
- Use of systemic corticosteroids, immunosuppressive or anticancer medications in the last six months
- Chronic condition that, in the opinion of the investigator or the designated trial physician, would make the volunteer unsuitable for the study
Any of the following abnormal laboratory parameters:
- Hemoglobin <9.0 g/dL (females), <12.0 g/dL (males)
- Absolute Neutrophil Count (ANC): ≤ 999/mm3
- Absolute Lymphocyte Count (ALC): ≤ 500/mm3
- Platelets: decreased ≤ 90,000 or increased ≥ 550,000/mm3
- Creatinine: > 1.4 x ULN
- AST: >3.0 x ULN
- ALT: >3.0 x ULN
- Urine dipstick: blood = 2+ or more (except in menstruating females); protein = 2+ or more
Any of the following high-risk behaviors:
- Had unprotected vaginal or anal sex with a known HIV positive person in the past six months
- Had unprotected vaginal or anal sex with a casual partner (i.e. no continuing established relationship) in the past six months
- Engaged in sex work for money or drugs in the past six months
- Used injection drugs illegally in the past six months
- Acquired a sexually transmitted infection (STI) in the past six months
- If female, pregnant, lactating or planning a pregnancy within four months after last study injection
- Receipt of live attenuated vaccine within 30 days or other vaccine within 14 days of the first study injection
- Receipt of blood transfusion or blood products six months prior to the first study injection
- Participation in another clinical trial of an investigational product currently or within last 12 weeks of first study injection or expected participation during this study
- Prior receipt of an investigational HIV vaccine
- History of severe local or systemic reaction to vaccination(s) or history of severe allergic reactions
- History of major neurological or psychiatric disorders
- Positive for hepatitis B surface antigen, active untreated syphilis (confirmed by treponemal test such as TPHA in addition to nontreponemal test such as RPR) or other active sexually transmitted diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Group A
Number of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0 + 6 |
|
실험적: Group B
Number of Vaccine Recipients: 10 Dosage level 3 x 10^10 DRP Month 0+12 |
|
실험적: Group C
Number of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+6 |
|
실험적: Group D
Number of Vaccine Recipients: 10 Dosage level 3 x 10^11 DRP Month 0+12 |
|
실험적: Group E
Number of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+6 |
|
실험적: Group F
Number of Vaccine Recipients: 10 Dosage level 3 x 10^12 DRP Month 0+12 |
|
실험적: Group G
Number of Vaccine Recipients: 10 Preselected for baseline AAV neutralization titers of <1/8 Dosage level 3 x 10^12 DRP Month 0+6 |
|
위약 비교기: Placebo
3 volunteers will receive placebo matched to each experimental group.
|
Sterile isotonic buffered salt solution
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Safety: proportion of volunteers with severe local and systemic reactions, proportion of volunteers with other SAEs (including laboratory abnormalities) related to study vaccine, number of volunteers with SAEs related to study vaccine
기간: 18 months
|
18 months
|
Proportion of volunteers with HIV-1 specific T- cell responses quantified by γ-IFN ELISPOT and magnitude of the response, and proportion of volunteers with HIV-1 specific binding antibodies and magnitude of the response
기간: 18 months
|
18 months
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Safety: high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
기간: 18 months
|
18 months
|
Immunogenicity: proportion of volunteers with HIV-1 specific T- cell responses by γ-IFN CFC or other T-cell assays
기간: 18 months
|
18 months
|
Immunogenicity endpoints in volunteers with high versus low or negative titres of neutralizing antibodies to AAV2 at the time of each vaccination
기간: 18 months
|
18 months
|
Immunogenicity endpoints in volunteers with versus without four-fold or greater increase in titres of neutralizing antibodies to AAV2 after vaccination
기간: 18 months
|
18 months
|
Immunogenicity endpoints after the second study injection, compared with the first study injection
기간: 18 months
|
18 months
|
Immunogenicity endpoints after the second study injection following a twelve-month interval compared to a six-month interval
기간: 18 months
|
18 months
|
Vaccine biodistribution: presence and persistence of vaccine in peripheral blood mononuclear cells (PBMC), saliva, nasal swabs, urine and semen or cervical/vaginal secretions
기간: 18 months
|
18 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: Eftyhia Vardas, MD, Perinatal HIV Research Unit (PHRU), Baragwanath
- 수석 연구원: Linda-Gail Bekker, MD, Desmond Tutu HIV Centre Cape Town
- 수석 연구원: Anwar Hoosen, Medical University of Southern Africa (Medunsa)
- 수석 연구원: Elwyn Chomba, MD, Zambia-Emory HIV Research Project (ZEHRP), Lusaka
- 수석 연구원: Pontiano Kaleebu, MD, PhD, MRC/UVRI and LSHTM Uganda Research Unit
간행물 및 유용한 링크
유용한 링크
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IAVI A002
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