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HIV Vaccine Trial in Thai Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

HIV Vaccine Trial in Thai Adults

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

NCT00223080•U.S. Army Medical Research and Development Command

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 30 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (8)

Ban Lamung District Hospital

Ban Lamung District, Changwat Chon Buri, Thailand

Phan Tong District Hospital

Phan Tong District, Changwat Chon Buri, Thailand

Sattahip District Hospital

Sattahip District, Changwat Chon Buri, Thailand

Ao Udom Hospital

Sri Racha District, Changwat Chon Buri, Thailand

Ban Chang District Hospital

Ban Chang District, Changwat Rayong, Thailand

Ban Khai District Hospital

Ban Khai District, Changwat Rayong, Thailand

Klaeng District Hospital

Klaeng District, Changwat Rayong, Thailand

Provincial Health Office

Muang District, Changwat Rayong, Thailand

Key Dates

Start Date

October 1, 2003

Primary Completion Date

July 1, 2006

Completion Date

June 1, 2009

Last Updated

April 24, 2019

Enrollment

16,402

ACTUAL participants

Conditions

HIV Infection

Interventions

ALVAC-HIV vCP1521 + AIDSVAX

BIOLOGICAL

ALVAC Placebo + AIDSVAX Placebo

OTHER

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

NCT04929028

View study

RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HIV Vaccine Trial in Thai Adults

Inclusion Criteria

Exclusion Criteria

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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