A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16,402
- 试验地点
- 12
- 主要终点
- Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
研究概览
简要总结
The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.
详细描述
A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic. In this phase III efficacy trial, a 'prime-boost' vaccine strategy is evaluated for prevention of infection and amelioration of disease course. ALVAC-HIV (vCP1521) from sanofi pasteur is given as the 'prime' vaccine at months 0, 1, 3 and 6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6. This regimen will be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a double-blinded, randomized manner. Following the completion of each subjects immunization phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV testing, pre- and post-test counseling. Subjects who become HIV infected will be counseled, referred to HIV treatment facilities for management according to national guidelines, and offered enrollment in a protocol for extended follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Possession of the 13-digit Thai National ID card
- •18-30 years of age (inclusive), male or female
- •For women, a negative urine pregnancy test on the day of enrollment, as well as assurance that adequate birth control measures would be applied during the course of the injections and the 3 months after the last injection.
- •Absence of systemic disease or immunodeficiency as determined by medical history and directed physical examination.
- •Negative serology for HIV-1 infection within 45 days prior to enrollment.
- •Availability and commitment for 3.5 years of participation.
- •Able to understand the study (shown by receiving a passing score on the Test of Understanding administered under the screening protocol) and gave written informed consent.
- •Enrollment in and referral from screening protocol, RV148
排除标准
- •Previous participation in any HIV vaccine trial (unless the volunteer could provide documentation that he/she received placebo).
- •Active tuberculosis, other systemic disease process, or immunodeficiency as detected by medical history and directed physical examination that would, in the opinion of the investigator, impede compliance with study requirements or complicate the interpretation of adverse events.
- •Any significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study or might interfere with the volunteer's ability to successfully complete the study.
- •Occupational or other responsibilities that would prevent completion of 3.5 years of participation in the study.
- •History of anaphylaxis or other serious adverse reactions to vaccines, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including egg products and neomycin.
- •Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the 9-month window between study enrollment and 3-months after the last vaccination visit.
- •Study site employees who were involved in the protocol and may have had direct access to trial-related data.
- •Chronic use of therapies which may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of > 20 mg prednisone equivalent for periods exceeding 10 days), and use of experimental drugs or vaccines.
- •Receipt of a non-HIV vaccine or immune globulins within 14 days.
研究组 & 干预措施
Vaccine
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
干预措施: ALVAC-HIV vCP1521 + AIDSVAX (Biological)
Placebo
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
干预措施: ALVAC Placebo + AIDSVAX Placebo (Other)
结局指标
主要结局
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
时间窗: 42 months
Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
时间窗: 42 Months
Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
时间窗: 42 Months
HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
时间窗: 42 months
Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
次要结局
- Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)(Week 182)
- Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population(42 weeks)
- Safety Assessment (SAE's and AEs)(Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u period)