NCT00001906 - 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)

Guirges SY
Natural and experimental re-infection of man with Oriental sore. Ann Trop Med Parasitol. 1971 Jun;65(2):197-205.
Modabber F
Experiences with vaccines against cutaneous leishmaniasis: of men and mice. Parasitology. 1989;98 Suppl:S49-60. Review.
Naggan L, Gunders AE, Michaeli D
Follow-up study of a vaccination programme against cutaneous leishmaniasis. II. Vaccination with a recently isolated strain of L. tropica from Jericho. Trans R Soc Trop Med Hyg. 1972;66(2):239-43.

Safety and Immunogenicity of a Vaccine for Cutaneous Leishmaniasis Using Recombinant Human Interleukin-12 and Aluminum Hydroxide Gel as Adjuvants

Clinical trial NCT00001906 - References