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Title: Phase I trial of the SPf66 malaria vaccine in a malaria-experienced population in Southeast Asia
Authors: Francois Nosten
Christine Luxemburger
Dennis E. Kyle
Daniel M. Gordon
W. Ripley Ballou
Jerald C. Sadoff
Alan Brockman
Barynen Permpanich
Tan Chongsuphajaisiddhi
D. Gray Heppner
Shoklo Malaria Research Unit
Walter Reed Army Institute of Research
Armed Forces Research Institute of Medical Sciences, Thailand
Mahidol University
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Jan-1997
Citation: American Journal of Tropical Medicine and Hygiene. Vol.56, No.5 (1997), 526-532
Abstract: In preparation for a recently reported, independent field trial of SPf66 malaria vaccine efficacy in Thailand, we first established the safety and immunogenicity of two clinical lots of U.S. manufactured lots of SPf66 in a series of overlapping Phase I studies. The vaccine was produced in approved laboratories using good manufacturing practices. Two clinical lots of alum- absorbed SPf66 were evaluated in a combined, open-label, Phase I clinical trial involving 50 healthy, malaria-experienced Karen adults and children. Volunteers were grouped by age and immunized sequentially. Group 1 had 30 adults, Group 2 had 10 children 8-15 years of age, and Group 3 had 10 children 2-6 years of age. The SPf66 vaccine was well tolerated in this malaria-experienced population. The most common side effects were erythema, induration, warmth, and tenderness at the site of injection, which typically resolved within 24-48 hr. One adult volunteer developed an acute urticarial rash following the third dose. Among adults, and to a lesser extent older children, females had more local reactions than their male counterparts. Seroconversion to SPf66 by enzyme-inked immunosorbent assay occurred in 76% of volunteers receiving two or three doses. This vaccine was safe and immunogenic in malaria-experienced Karen adults and children. This study establishes the comparability of U.S.-manufactured SPf66 with that of Colombian origin, and is important for interpreting the efficacy results of U.S.-manufactured SPf66 in the same study population.
ISSN: 00029637
Appears in Collections:Scopus 1991-2000

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