Safety, immunogenecity, and efficacy of an autoclaved Leishmania amazonensis vaccine plus BCG adjuvant against New World cutaneous leishmaniasis.

Abstract

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.

• Authors: R X Armijos, M M Weigel, M Calvopina, A Hidalgo, W Cevallos, J Correa
• Journal: Vaccine (Vaccine) Vol. 22 Issue 9-10 Pg. 1320-6 (Mar 12 2004) ISSN: 0264-410X [Print] Netherlands
• PMID: 15003662 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Immunologic
• BCG Vaccine
• Protozoan Vaccines

Topics

• Adjuvants, Immunologic
• Animals
• BCG Vaccine (adverse effects, immunology)
• Child
• Ecuador
• Female
• Follow-Up Studies
• Hot Temperature
• Humans
• Leishmania mexicana (genetics, immunology)
• Leishmaniasis, Cutaneous (immunology, prevention & control)
• Male
• Protozoan Vaccines (adverse effects, immunology)
• Reverse Transcriptase Polymerase Chain Reaction
• Skin Tests
• Sterilization
• Treatment Outcome
• Vaccination