Safety, immunogenecity, and efficacy of an autoclaved Leishmania amazonensis vaccine plus BCG adjuvant against New World cutaneous leishmaniasis.
The safety, immunogenecity, and efficacy of two doses of an autoclaved-killed, whole cell Leishmania amazonensis vaccine (IFLA/BR/67/PH8) and BCG adjuvant (n = 750) against cutaneous leishmaniasis (CL) was compared with placebo (n = 756) in a randomized, placebo-controlled, blinded study. Systemic and local side-effects were more frequent in the vaccine than placebo group. Leishmanin skin test (LST) conversion was greater in the vaccine than placebo group 2 months after the second vaccination dose (74.4% versus 14.7%; P = 0.000001). The 26-month incidence of confirmed CL (n = 25) was similar between the vaccine (2.0%) and placebo groups (2.0% versus 1.3%; P > 0.05). LST conversion was not associated with CL protection and the vaccine did not offer significant protection against CL infection caused by L. Viannia spp. compared to placebo.
Health Sciences Program, College of Health Sciences, University of Texas at El Paso, Room 705, 1101 North Campbell Street, El Paso, TX 79902-0581, USA. rxarmijos@utep.edu
R X
RX
Armijos
M M
MM
Weigel
M
M
Calvopina
A
A
Hidalgo
W
W
Cevallos
J
J
Correa
D000276:Adjuvants, Immunologic; D000818:Animals; D001500:BCG Vaccine / Q000009:adverse effects / Q000276:immunology*; D002648:Child; D004484:Ecuador; D005260:Female; D005500:Follow-Up Studies; D006358:Hot Temperature; D006801:Humans; D007894:Leishmania mexicana / Q000235:genetics / Q000276:immunology*; D016773:Leishmaniasis, Cutaneous / Q000276:immunology* / Q000517:prevention & control*; D008297:Male; D016052:Protozoan Vaccines / Q000009:adverse effects / Q000276:immunology*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012882:Skin Tests; D013242:Sterilization; D016896:Treatment Outcome; D014611:Vaccination
D000276:Adjuvants, Immunologic; D001500:BCG Vaccine; D016052:Protozoan Vaccines