At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Safety and Immunogenicity Trial of IHV01 in HIV-1 Uninfected Volunteers
In Brief
A Phase 1 clinical trial evaluating 300 ug FLSC vaccine, 150 ug FLSC vaccine, and 2 other interventions for HIV Infection. Completed, enrolled 65 participants across 1 site.
Detailed Summary
This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized, placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult volunteers (Human Immunodeficiency Virus-1 uninfected).
Study Details
Timeline
Interventions
FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168