HIV Vaccine Trial in Thai Adults
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| ClinicalTrials.gov Identifier: NCT00223080 |
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Recruitment Status :
Completed
First Posted : September 22, 2005
Results First Posted : October 19, 2018
Last Update Posted : April 24, 2019
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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
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infection | Biological: ALVAC-HIV vCP1521 + AIDSVAX Other: ALVAC Placebo + AIDSVAX Placebo | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 16402 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| 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 Start Date : | October 2003 |
| Actual Primary Completion Date : | July 2006 |
| Actual Study Completion Date : | June 2009 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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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.
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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:
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Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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)
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| Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223080
Locations
| Thailand | |
| Ban Lamung District Hospital | |
| Ban Lamung District, Chon Buri, Thailand | |
| Phan Tong District Hospital | |
| Phan Tong District, Chon Buri, Thailand, 20160 | |
| Sattahip District Hospital | |
| Sattahip District, Chon Buri, Thailand, 20180 | |
| Ao Udom Hospital | |
| Sri Racha District, Chon Buri, Thailand, 20230 | |
| Ban Chang District Hospital | |
| Ban Chang District, Rayong, Thailand | |
| Ban Khai District Hospital | |
| Ban Khai District, Rayong, Thailand | |
| Klaeng District Hospital | |
| Klaeng District, Rayong, Thailand | |
| Provincial Health Office | |
| Muang District, Rayong, Thailand, 21000 | |
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
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
Investigators
| Principal Investigator: | Supachai Rerks-Ngarm, MD | Ministry of Health, Thailand |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | U.S. Army Medical Research and Development Command |
| ClinicalTrials.gov Identifier: | NCT00223080 History of Changes |
| Other Study ID Numbers: |
RV144 HSRRB A-11048 ( Other Identifier: USAMRMC HSRRB ) |
| First Posted: | September 22, 2005 Key Record Dates |
| Results First Posted: | October 19, 2018 |
| Last Update Posted: | April 24, 2019 |
| Last Verified: | April 2019 |
Keywords provided by U.S. Army Medical Research and Development Command:
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HIV Seronegativity |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Aluminum Hydroxide Vaccines Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |