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.
Armijos
R X
RX
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
Weigel
M M
MM
Calvopina
M
M
Hidalgo
A
A
Cevallos
W
W
Correa
J
J
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