NCT00111605 - 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)

Bolesta E, Gzyl J, Wierzbicki A, Kmieciak D, Kowalczyk A, Kaneko Y, Srinivasan A, Kozbor D
Clustered epitopes within the Gag-Pol fusion protein DNA vaccine enhance immune responses and protection against challenge with recombinant vaccinia viruses expressing HIV-1 Gag and Pol antigens. Virology. 2005 Feb 20;332(2):467-79. Erratum in: Virology. 2005 May 10;335(2):291.
Letvin NL
Progress toward an HIV vaccine. Annu Rev Med. 2005;56:213-23. Review.
Sha BE, Onorato M, Bartlett JA, Bosch RJ, Aga E, Nokta M, Adams EM, Li XD, Eldridge J, Pollard RB
Safety and immunogenicity of a polyvalent peptide C4-V3 HIV vaccine in conjunction with IL-12. AIDS. 2004 May 21;18(8):1203-6.

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants

Details for clinical trial NCT00111605

Clinical trial NCT00111605 - References