Phase 3
N=16,395
HIV Vaccine Trial in Thai Adults
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT00223080 ↗Enrolled (actual)
16,395
Serious AEs
14.6%
Results posted
Oct 2018
Primary outcome: Primary: Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population — 0.15; 0.38; 0.41; 0.64 Percetage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALVAC-HIV vCP1521 + AIDSVAX (Biological); ALVAC Placebo + AIDSVAX Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- U.S. Army Medical Research and Development Command
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population |
0.15; 0.38; 0.41; 0.64; 0.58; 0.84 | — |
| PRIMARY Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population |
0.08; 0.25; 0.36; 0.49; 0.52; 0.70 | — |
| PRIMARY Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population |
4.379; 4.187; 4.229; 4.235; 4.274; 4.167 | — |
| PRIMARY Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population |
4.307; 4.153; 4.128; 4.276; 4.280; 4.143 | — |
| SECONDARY Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population |
565.4; 566.7; 539.6; 570.6 | — |
| SECONDARY Safety Assessment (SAE's and AEs) |
1277; 1336; 816; 860; 614; 597 | — |
| SECONDARY Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT) |
702; 763; 6223; 6130; 473; 502 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00223080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.