HIV Vaccine Trial in Thai Adults

Phase 3

Completed

Conditions: HIV Infection

Interventions: Other: ALVAC Placebo + AIDSVAX Placebo
Biological: ALVAC-HIV vCP1521 + AIDSVAX

Registration Number: NCT00223080

Lead Sponsor: U.S. Army Medical Research and Development Command

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16402

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ALVAC Placebo + AIDSVAX Placebo	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
Vaccine	ALVAC-HIV vCP1521 + AIDSVAX	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.

Primary Outcome Measures

Name	Time	Method
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population	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.
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population	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.
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)	Week 182	Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question "Do you think that your everyday behavior puts you at risk for HIV infection?" Modified intent to treat population (MITT)
Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population	42 weeks	Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
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	The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized

Trial Locations

Locations (8): Klaeng District Hospital
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Klaeng District, Rayong, Thailand
Ban Lamung District Hospital
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Ban Lamung District, Chon Buri, Thailand
Phan Tong District Hospital
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Phan Tong District, Chon Buri, Thailand
Sattahip District Hospital
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Sattahip District, Chon Buri, Thailand
Ao Udom Hospital
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Sri Racha District, Chon Buri, Thailand
Ban Chang District Hospital
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Ban Chang District, Rayong, Thailand
Ban Khai District Hospital
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Ban Khai District, Rayong, Thailand
Provincial Health Office
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Muang District, Rayong, Thailand