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HIV Vaccine Trial in Thai Adults

Primary Purpose

HIV Infection

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
ALVAC-HIV vCP1521 + AIDSVAX
ALVAC Placebo + AIDSVAX Placebo
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection focused on measuring HIV Seronegativity

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ban Lamung District Hospital
  • Phan Tong District Hospital
  • Sattahip District Hospital
  • Ao Udom Hospital
  • Ban Chang District Hospital
  • Ban Khai District Hospital
  • Klaeng District Hospital
  • Provincial Health Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vaccine

Placebo

Arm Description

ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.

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

Outcomes

Primary Outcome Measures

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

Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
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)
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
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
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)

Full Information

First Posted
September 13, 2005
Last Updated
April 10, 2019
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
United States Army Medical Materiel Development Activity, Armed Forces Research Institute of Medical Sciences, Thailand, Walter Reed Army Institute of Research (WRAIR), MCM Vaccines B.V., VaxGen, The Emmes Company, LLC, Ministry of Health, Thailand, Mahidol University, Royal Thai Army Medical Department, Tripler Army Medical Center, Henry M. Jackson Foundation for the Advancement of Military Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00223080
Brief Title
HIV Vaccine Trial in Thai Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaccine
Arm Type
Active Comparator
Arm Description
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
Intervention Type
Biological
Intervention Name(s)
ALVAC-HIV vCP1521 + AIDSVAX
Other Intervention Name(s)
ALVAC-HIV (vCP1521) >106 CCID50 per 1 mL dose, AIDSVAX® B/E, Bivalent HIV gp120 vaccine subtype B (MN), and E (A244)
Intervention Description
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
Other
Intervention Name(s)
ALVAC Placebo + AIDSVAX Placebo
Other Intervention Name(s)
ALVAC carrier lyophilized product without virus, Aluminum hydroxide adjuvant
Intervention Description
ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
Description
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.
Time Frame
42 Months
Title
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
Description
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.
Time Frame
42 Months
Title
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
Description
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.
Time Frame
42 months
Title
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
Description
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.
Time Frame
42 months
Secondary Outcome Measure Information:
Title
Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
Description
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.
Time Frame
42 weeks
Title
Safety Assessment (SAE's and AEs)
Description
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
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
Title
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
Description
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)
Time Frame
Week 182

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Supachai Rerks-Ngarm, MD
Organizational Affiliation
Ministry of Health, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ban Lamung District Hospital
City
Ban Lamung District
State/Province
Chon Buri
Country
Thailand
Facility Name
Phan Tong District Hospital
City
Phan Tong District
State/Province
Chon Buri
ZIP/Postal Code
20160
Country
Thailand
Facility Name
Sattahip District Hospital
City
Sattahip District
State/Province
Chon Buri
ZIP/Postal Code
20180
Country
Thailand
Facility Name
Ao Udom Hospital
City
Sri Racha District
State/Province
Chon Buri
ZIP/Postal Code
20230
Country
Thailand
Facility Name
Ban Chang District Hospital
City
Ban Chang District
State/Province
Rayong
Country
Thailand
Facility Name
Ban Khai District Hospital
City
Ban Khai District
State/Province
Rayong
Country
Thailand
Facility Name
Klaeng District Hospital
City
Klaeng District
State/Province
Rayong
Country
Thailand
Facility Name
Provincial Health Office
City
Muang District
State/Province
Rayong
ZIP/Postal Code
21000
Country
Thailand

12. IPD Sharing Statement

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HIV Vaccine Trial in Thai Adults

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