Clinical trial NCT00223080: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Keywords: HIV Seronegativity
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: United States Army Medical Materiel Development Activity
name: Armed Forces Research Institute of Medical Sciences, Thailand
name: Walter Reed Army Institute of Research (WRAIR)
name: MCM Vaccines B.V.
name: VaxGen
name: The Emmes Company, LLC
name: Ministry of Health, Thailand
name: Mahidol University
name: Royal Thai Army Medical Department
name: Tripler Army Medical Center
name: Henry M. Jackson Foundation for the Advancement of Military Medicine
First posted: 2005-09-22
Enrollment: 16402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
timeFrame: 42 Months
measure: Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
timeFrame: 42 Months
measure: Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
timeFrame: 42 months
measure: Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
timeFrame: 42 months
Secondary outcomes:
measure: Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
timeFrame: 42 weeks
measure: Safety Assessment (SAE's and AEs)
timeFrame: 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
measure: Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
timeFrame: Week 182
Other outcomes:
Locations:
city: Ban Lamung District
country: Thailand
facility: Ban Lamung District Hospital
state: Chon Buri
city: Phan Tong District
country: Thailand
facility: Phan Tong District Hospital
state: Chon Buri
city: Sattahip District
country: Thailand
facility: Sattahip District Hospital
state: Chon Buri
city: Sri Racha District
country: Thailand
facility: Ao Udom Hospital
state: Chon Buri
city: Ban Chang District
country: Thailand
facility: Ban Chang District Hospital
state: Rayong
city: Ban Khai District
country: Thailand
facility: Ban Khai District Hospital
state: Rayong
city: Klaeng District
country: Thailand
facility: Klaeng District Hospital
state: Rayong
city: Muang District
country: Thailand
facility: Provincial Health Office
state: Rayong
Study officials:
affiliation: Ministry of Health, Thailand
name: Supachai Rerks-Ngarm, MD
role: PRINCIPAL_INVESTIGATOR
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