HIV Vaccine Trial in Thai Adults

April 10, 2019 updated by: U.S. Army Medical Research and Development Command

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16402

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chon Buri
      • Ban Lamung District, Chon Buri, Thailand
        • Ban Lamung District Hospital
      • Phan Tong District, Chon Buri, Thailand, 20160
        • Phan Tong District Hospital
      • Sattahip District, Chon Buri, Thailand, 20180
        • Sattahip District Hospital
      • Sri Racha District, Chon Buri, Thailand, 20230
        • Ao Udom Hospital
    • Rayong
      • Ban Chang District, Rayong, Thailand
        • Ban Chang District Hospital
      • Ban Khai District, Rayong, Thailand
        • Ban Khai District Hospital
      • Klaeng District, Rayong, Thailand
        • Klaeng District Hospital
      • Muang District, Rayong, Thailand, 21000
        • Provincial Health Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Biological: 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
Other Names:
  • ALVAC-HIV (vCP1521) >106 CCID50 per 1 mL dose
  • AIDSVAX® B/E
  • Bivalent HIV gp120 vaccine subtype B (MN), and E (A244)
Placebo Comparator: Placebo
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
Other: 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
Other Names:
  • ALVAC carrier lyophilized product without virus
  • Aluminum hydroxide adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
Time Frame: 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.
42 Months
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
Time Frame: 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.
42 Months
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
Time Frame: 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.
42 months
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
Time Frame: 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.
42 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
Time Frame: 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.
42 weeks
Safety Assessment (SAE's and AEs)
Time Frame: 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
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
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
Time Frame: 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)
Week 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Walter Reed Army Institute of Research (WRAIR)
Mahidol University
The Emmes Company, LLC
MCM Vaccines B.V.
Henry M. Jackson Foundation for the Advancement of Military Medicine
Ministry of Health, Thailand
Armed Forces Research Institute of Medical Sciences, Thailand
VaxGen
Tripler Army Medical Center
United States Army Medical Materiel Development Activity
Royal Thai Army Medical Department

Investigators

  • Principal Investigator: Supachai Rerks-Ngarm, MD, Ministry of Health, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RV144
  • HSRRB A-11048 (Other Identifier: USAMRMC HSRRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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