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Field trials of an asexual blood stage malaria vaccine: studies of the synthetic peptide polymer SPf66 in Thailand and the analytic plan for a phase IIb efficacy study

Published online by Cambridge University Press:  06 April 2009

W. R. Ballou ,
J. Blood ,
T. Chongsuphajaissidhi ,
D. M. Gordon ,
D. G. Heppner ,
D. E. Kyle ,
C. Luxemburger ,
F. Nosten ,
J. C. Sadoff  and
P. Singhasivanon
...Show all authors
W. R. Ballou*
Affiliation:
Division of Communicable Diseases and Immunology, WRAIR, Washington, D.C.
J. Blood
Affiliation:
Statistics Collaborative, Washington, D.C.
T. Chongsuphajaissidhi
Affiliation:
Hospital for Tropical Diseases, Mahidol University, Bangkok, Thailand
D. M. Gordon
Affiliation:
Division of Communicable Diseases and Immunology, WRAIR, Washington, D.C.
D. G. Heppner
Affiliation:
Department of Immunology, U.S. Component, AFRIMS, Bangkok, Thailand
D. E. Kyle
Affiliation:
Department of Immunology, U.S. Component, AFRIMS, Bangkok, Thailand
C. Luxemburger
Affiliation:
Shoklo Malaria Research Unit, Mae Sot, Thailand
F. Nosten
Affiliation:
Division of Communicable Diseases and Immunology, WRAIR, Washington, D.C.
J. C. Sadoff
Affiliation:
Division of Communicable Diseases and Immunology, WRAIR, Washington, D.C.
P. Singhasivanon
Affiliation:
Nuffield Department of Clinical Medicine, John Radcliffe Hospital, Oxford, UK
N. J. White
Affiliation:
Nuffield Department of Clinical Medicine, John Radcliffe Hospital, Oxford, UK
K. H. Webster
Affiliation:
Department of Immunology, U.S. Component, AFRIMS, Bangkok, Thailand
J. Wittes
Affiliation:
Department of Immunology, U.S. Component, AFRIMS, Bangkok, Thailand
C. Wongsrichanalai
Affiliation:
Department of Immunology, U.S. Component, AFRIMS, Bangkok, Thailand
*
* W. Ripley Ballou, Department of Immunology, Walter Reed Army Institute of Research, Washington, D.C. 20307–5100.
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Summary

Several years ago the Walter Reed Army Institute of Research (WRAIR) initiated an independent analysis of the candidate malaria blood stage vaccine SPf66. WRAIR contracted for the synthesis and formulation of SPf66 in United States Food and Drug Administration (FDA) inspected laboratories within the U.S., and in 1992, filed an Investigational New Drug (IND) application with the FDA. Preclinical studies indicated that the vaccine could be synthesized to meet its release specifications, and when adjuvanted with alum, was essentially equivalent to Colombian produced SPf66 in regards to immunogenicity in preclinical studies of rodents and primates, and in human volunteers in Phase I studies. The goal of these efforts was ultimately to conduct a Phase IIb field trial to determine the safety and efficacy of SPf66 produced under current Good Manufacturing Practices (cGMP). Such a trial is currently underway in a malaria endemic refugee camp along the Thai–Burmese border. Here we briefly describe the study and present the formal analytic plan that was submitted to regulatory authorities in the United States for analysis of the study results. We believe such independent confirmatory studies are an essential part of the vaccine development process and are required to provide important data regarding the safety and efficacy of candidate vaccines in diverse geographical regions, and as a means to assess their role in the context of broader malaria control programmes.

Keywords

malariavaccinesfield trialsSPf66
Type
Research Article
Information
Parasitology , Volume 110 , Supplement S1: Symposia of the British Society for Parasitology Volume 32:Parasite vaccines , March 1995 , pp. S25 - S36
Copyright
Copyright © Cambridge University Press 1995

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