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HIV Vaccine Trial in Thai Adults

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ClinicalTrials.gov Identifier: NCT00223080
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : October 19, 2018
Last Update Posted : November 20, 2018
Sponsor:
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 Corporation
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
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date October 24, 2016
Results First Posted Date October 19, 2018
Last Update Posted Date November 20, 2018
Study Start Date  ICMJE October 2003
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
HIV infection, assessed every 6 months for 3 years
Change History Complete list of historical versions of study NCT00223080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2017)
  • 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.
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
HIV viral load and CD4 counts after infection which occur during the 3 year follow-up period
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE HIV Vaccine Trial in Thai Adults
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE HIV Infection
Intervention  ICMJE
  • 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)
  • 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
Study Arms
  • 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.
    Intervention: Biological: ALVAC-HIV vCP1521 + AIDSVAX
  • 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.
    Intervention: Other: ALVAC Placebo + AIDSVAX Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2007)
16402
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
16000
Actual Study Completion Date June 2009
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223080
Other Study ID Numbers  ICMJE RV144
HSRRB A-11048 ( Other Identifier: USAMRMC HSRRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party U.S. Army Medical Research and Materiel Command
Study Sponsor  ICMJE U.S. Army Medical Research and Materiel Command
Collaborators  ICMJE
  • 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 Corporation
  • 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
Investigators  ICMJE
Principal Investigator: Supachai Rerks-Ngarm, MD Ministry of Health, Thailand
PRS Account U.S. Army Medical Research and Materiel Command
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP