NCT00384787 - 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)

Barouch DH, Nabel GJ
Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. Review.
Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM
Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. Epub 2004 Nov 3.
Pittman PR, Kim-Ahn G, Pifat DY, Coonan K, Gibbs P, Little S, Pace-Templeton JG, Myers R, Parker GW, Friedlander AM
Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine. 2002 Jan 31;20(9-10):1412-20.
Shiver JW, Emini EA
Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. Review.

A Phase Ib Clinical Trial to Compare the Safety, Tolerability, and Immunogenicity of an HIV-1 Adenoviral Vector Boost Administered Intramuscularly, Intradermally, or Subcutaneously After an HIV-1 DNA Plasmid Vaccine Prime Administered Intramuscularly to Healthy Adenovirus Type 5 Seropositive HIV-1-Uninfected Adults

Details for clinical trial NCT00384787

Clinical trial NCT00384787 - References