Alum-precipitated autoclaved leishmania major plus bacille calmette-guerrin, a candidate vaccine for visceral leishmaniasis: safety, skin-delayed type hypersensitivity response and dose finding in healthy volunteers


Kamil, AA; Khalil, EAG; Musa, AM; Modabber, F; Mukhtar, MM; Ibrahim, ME; Zijlstra, EE; Sacks, D; Smith, PG; Zicker, F; el-Hassan, AM; (2003) Alum-precipitated autoclaved leishmania major plus bacille calmette-guerrin, a candidate vaccine for visceral leishmaniasis: safety, skin-delayed type hypersensitivity response and dose finding in healthy volunteers. Transactions of the Royal Society of Tropical Medicine and Hygiene, 97 (3). p. 365. ISSN 0035-9203 DOI: 10.1016/S0035-9203(03)90171-4

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Abstract

In a previous efficacy study, autoclaved Leishmania major (ALM) + bacille Calmette-Guerrin (BCG) vaccine was shown to be safe, but not superior to BCG alone, in protecting against visceral leishmaniasis. From June 1999 to June 2000, we studied the safety and immunogenicity of different doses of alum- precipitated ALM + BCG vaccine mixture administered intradermally to evaluate whether the addition of alum improved the immunogenicity of ALM. Twenty-four healthy adult volunteers were recruited and sequentially allocated to receive either 10 mug, 100 mug, 200 mug, or 400 mug of leishmanial protein in the alum-precipitated ALM + BCG vaccine mixture. Side effects were minimal for all doses and confined to the site of injection. All volunteers in the 10 mug, 100 mug, and 400 mug groups had a leishmanin skin test (LST) reaction of greater than or equal to 5 mm by day 42 and this response was maintained when tested after 90 d. Only 1 volunteer out of 5 in the 200 mug group had a LST reaction of greater than or equal to 5 mm by day 42 and the reasons for the different LST responses in this group are unclear. This is the first time that an alum adjuvant with ALM has been in used in humans and the vaccine mixture was safe and induced a strong delayed type hypersensitivity (DTH) reaction in the study volunteers. On the basis of this study we suggest that 100 mug of leishmanial protein in the vaccine mixture is a suitable dose for future efficacy studies, as it induced the strongest DTH reaction following vaccination.

Item Type: Article
Keywords: visceral leishmaniasis, Leishmania major, alum, bacille, Calmette-Guerrin, vaccine, Sudan, Kala-azar, cutaneous leishmaniasis, bcg, donovani, sudan, immunogenicity, adjuvants, reactivity, prospects, infection
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Leishmaniasis Group
Centre for Global Non-Communicable Diseases (NCDs)
Neglected Tropical Diseases Network
Vaccine Centre
PubMed ID: 15228261
Web of Science ID: 222383800024
URI: http://researchonline.lshtm.ac.uk/id/eprint/14524

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