Safety and immunogenicity of a killed Leishmania (L.) amazonensis vaccine against cutaneous leishmaniasis in Colombia: a randomized controlled trial.
Trans R Soc Trop Med Hyg
; 94(6): 698-703, 2000.
Article
in En
| MEDLINE
| ID: mdl-11198661
The safety and immunogenicity of an intramuscular (i.m.) and intradermal (ID) formulation of autoclaved Leishmania (Leishmania) amazonensis vaccine was evaluated in 296 volunteers in a randomized, placebo-controlled, double-blind trial in Colombia. There were 4 vaccination groups: i.m. vaccine, i.m. placebo, ID vaccine, and ID placebo. The ID formulations were mixed with BCG as adjuvant at the time of injection. For each group, 3 vaccinations were given with a 20-day interval between injections, and adverse events were monitored at 20 min, and at 2, 7 and 21 days after each injection. BCG-induced adverse reactions resulted in cancellation of the third vaccine administration in the ID groups. Antibody titres did not differ significantly between the groups. Montenegro skin-test conversion was achieved by 86.4% and 90% of the i.m. vaccine group and by 25% and 5% of the i.m. placebo group 80 days and 1 year after vaccination, respectively. A significant increase in mean Leishmania-antigen lymphocyte proliferation indexes was observed after i.m. vaccine immunization, but not after i.m. placebo immunization, 80 days and 1 year after vaccination. Significant levels of IFN gamma but not IL-10 were observed 1 year after vaccination in the i.m. vaccine group compared to the i.m. placebo group. The good safety profile and evidence of Th1 immune reactions due to i.m. vaccination in this phase-I/II study suggest that a population-based phase-III efficacy trial of the i.m. vaccine should be initiated.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Leishmania mexicana
/
Vaccines, Inactivated
/
Leishmaniasis, Cutaneous
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limits:
Animals
/
Humans
Country/Region as subject:
America do sul
/
Colombia
Language:
En
Journal:
Trans R Soc Trop Med Hyg
Year:
2000
Document type:
Article
Affiliation country:
Colombia
Country of publication:
United kingdom