Publication: Phase I trial of the SPf66 malaria vaccine in a malaria-experienced population in Southeast Asia
Issued Date
1997-01-01
Resource Type
ISSN
00029637
Other identifier(s)
2-s2.0-0030955715
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
American Journal of Tropical Medicine and Hygiene. Vol.56, No.5 (1997), 526-532
Suggested Citation
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 Phase I trial of the SPf66 malaria vaccine in a malaria-experienced population in Southeast Asia. American Journal of Tropical Medicine and Hygiene. Vol.56, No.5 (1997), 526-532. doi:10.4269/ajtmh.1997.56.526 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/18003
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
Phase I trial of the SPf66 malaria vaccine in a malaria-experienced population in Southeast Asia
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.