At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1-2 Randomized, Double-blind, Placebo-controlled Clinical Trial of Clade C ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59® in HIV-uninfected Adults at Low Risk of HIV Infection
In Brief
A Phase 2 clinical trial evaluating ALVAC-HIV, Bivalent Subtype C gp120/MF59®, and 2 other interventions for HIV Infection. Completed, enrolled 252 participants across 5 sites.
Detailed Summary
The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. 252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study. The investigators are doing this study to answer several questions. * Are the study vaccines safe to give to people? * Are people able to take the study vaccines without becoming too uncomfortable? * How do people's immune systems respond to the study vaccines? (Your immune system protects you from disease.)
Study Details
Timeline
Interventions
a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and \< 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose.
2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection
a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM
Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection