At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 16,402 enrolled

Drug / intervention

ALVAC-HIV vCP1521 + AIDSVAX +1 morebiological

Likely dose

600 μg combined dose (300 μg each of ALVAC-HIV vCP1521 and AIDSVAX B/E), co-formulated in aluminum hydroxide gel at 600 μg/mL, administered as 1 mL injectionAI-extracted

Key inclusion· 6

✓Age 18-30 years (inclusive), male or female
✓Possession of Thai National ID card
✓HIV-negative by serology within 45 days prior to enrollment
✓No systemic disease or immunodeficiency by history and physical examination

Key exclusion· 6

✕Prior participation in HIV vaccine trials (unless documented placebo recipient)
✕Active tuberculosis or other systemic disease/immunodeficiency
✕History of anaphylaxis or serious adverse reactions to vaccines
✕Pregnant, breast-feeding, or planning pregnancy during 9-month window (enrollment to 3 months post-final vaccination)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00223080

NCT00223080Phase 3Completed

Compare CT.gov

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

U.S. Army Medical Research and Development Command·interventional·Posted Sep 22, 2005·Updated Apr 24, 2019

In Brief

A Phase 3 clinical trial evaluating ALVAC-HIV vCP1521 + AIDSVAX and ALVAC Placebo + AIDSVAX Placebo for HIV Infection. Completed, enrolled 16,402 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV Infection

CountriesThailand

CollaboratorsUnited 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

Timeline

Phase 3CompletedFinished

200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2003

First PostedSep 2005

Primary CompletionJul 2006

Study CompletionJun 2009

TodayJul 2026

First PostedSep 22, 2005

Enrollment StartOct 1, 2003

Primary CompletionJul 1, 2006

Study CompletionJun 1, 2009

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

ALVAC-HIV vCP1521 + AIDSVAXbiological

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

ALVAC Placebo + AIDSVAX Placeboother

ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection