Field Trial of a Vaccine against New World Cutaneous Leishmaniasis in an At‐Risk Child Population: Safety, Immunogenicity, and Efficacy during the First 12 Months of Follow‐Up
Open Access
- 1 May 1998
- journal article
- clinical trial
- Published by Oxford University Press (OUP) in The Journal of Infectious Diseases
- Vol. 177 (5) , 1352-1357
- https://doi.org/10.1086/515265
Abstract
The safety, immunogenicity, and efficacy of a vaccine against cutaneous leishmaniasis in rural Ecuadorian children was assessed in a randomized, controlled, double-blinded study. Vaccine group subjects received 2 intradermal doses of a whole, killed promastigote vaccine cocktail plus bacille Calmette-Guérin (BCG) adjuvant. Control subjects got 2 doses of BCG only. The subjects who received both vaccination doses, 438 in the vaccine group (79.3%) and 406 in the control group (83.4%), were followed for 12 months. No serious adverse side effects were identified in either group. Significantly more vaccine group subjects than controls converted to a positive Montenegro skin test (85.1% vs. 20.1%; χ2 = 279; P < .001). The incidence of cutaneous leishmaniasis was significantly reduced in the vaccine compared with the control group (2.1% vs. 7.6%; χ2 = 8.95; P < .003). The protective efficacy of the vaccine was 72.9% (95% confidence interval = 36.1%–88.5%).Keywords
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