NCT00076037 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Gilbert PB, Chiu YL, Allen M, Lawrence DN, Chapdu C, Israel H, Holman D, Keefer MC, Wolff M, Frey SE; NIAID HIV Vaccine Trials Network
Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. Vaccine. 2003 Jun 20;21(21-22):2933-47.
Somani J, Lonial S, Rosenthal H, Resnick S, Kakhniashvili I, Waller EK
A randomized, placebo-controlled trial of subcutaneous administration of GM-CSF as a vaccine adjuvant: effect on cellular and humoral immune responses. Vaccine. 2002 Dec 13;21(3-4):221-30.

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a CTL Multi-Epitope Peptide HIV Vaccine Formulated With RC529-SE, With or Without GM-CSF, in Healthy, HIV-1 Uninfected Adult Participants

Details for clinical trial NCT00076037

Clinical trial NCT00076037 - References