HIV Vaccine Trial in Thai Adults

NCT ID: NCT00223080

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-06-30

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.

Conditions

HIV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ALVAC-HIV vCP1521 + AIDSVAX

Intervention Type: BIOLOGICAL

Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL

Placebo

ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.

Group Type: PLACEBO_COMPARATOR

ALVAC Placebo + AIDSVAX Placebo

Intervention Type: OTHER

ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection

Interventions

ALVAC-HIV vCP1521 + AIDSVAX

Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL

Intervention Type: BIOLOGICAL

ALVAC Placebo + AIDSVAX Placebo

ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection

Intervention Type: OTHER

Other Intervention Names

ALVAC-HIV (vCP1521) >106 CCID50 per 1 mL dose; AIDSVAX® B/E; Bivalent HIV gp120 vaccine subtype B (MN), and E (A244); ALVAC carrier lyophilized product without virus; Aluminum hydroxide adjuvant

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Army Medical Materiel Development Activity

FED

Sponsor Role: collaborator

Armed Forces Research Institute of Medical Sciences, Thailand

OTHER_GOV

Sponsor Role: collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

MCM Vaccines B.V.

INDUSTRY

Sponsor Role: collaborator

VaxGen

INDUSTRY

Sponsor Role: collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

Ministry of Health, Thailand

OTHER_GOV

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: collaborator

Royal Thai Army Medical Department

OTHER_GOV

Sponsor Role: collaborator

Tripler Army Medical Center

FED

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Supachai Rerks-Ngarm, MD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Thailand

Locations

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

Countries

Thailand

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Other Identifiers

HSRRB A-11048

Identifier Type: OTHER

Identifier Source: secondary_id

RV144

Identifier Type: -

Identifier Source: org_study_id