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Killed Vaccine Deemed Protective in Clinical Trial.(Brief Article)
2001 FEB 14 - (NewsRx.com & NewsRx.net) --
- by Michelle Marble, staff medical writer -- According to a study from Colombia, a population-based trial of a killed Leishmania amazonensis vaccine should be initiated based on the results of Phase I/II trial.
"The safety and immunogenicity of an intramuscular (IM) and intradermal (ID) formulation of autoclaved Leishmania amazonensis vaccine was evaluated in 296 volunteers in a randomized, placebo-controlled, double-blind trial in Colombia," stated I.D. Velez and colleagues, University of Antioquia. "There were four vaccination groups: IM vaccine, IM placebo, ID vaccine, and ID placebo."
Velez et al. published the results of their study in the journal Transactions of the Royal Society of Tropical Medicine and Hygiene ("Safety and immunogenicity of a killed Leishmania (L.) amazonensis vaccine against cutaneous leishmaniasis in Colombia: A randomized controlled trial," Trans Roy Soc Trop Med Hyg, 2000;94(6):698-703).
ID formulations were mixed with bacillus Calmette-Guerin (BCG) as an adjuvant at the time of injection. Each group was given three vaccinations with a 20-day interval between injections. Patients were monitored for adverse events at 20 minutes and at two, seven, and 21 days after each injection.
The BCG adjuvant caused adverse reactions in the ID groups resulting in cancellation of the third vaccine dose, reported the authors. Comparison of antibody titres among the groups showed that levels did not differ significantly between them.
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Source: HighBeam Research, Killed Vaccine Deemed Protective in Clinical Trial.(Brief Article)