Publication: SPf66 malaria vaccine is safe and immunogenic in malaria naive adults in Thailand
Issued Date
1997-09-30
Resource Type
ISSN
0001706X
Other identifier(s)
2-s2.0-17444444396
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Acta Tropica. Vol.67, No.3 (1997), 215-227
Suggested Citation
S. Migasena, D. G. Heppner, D. E. Kyle, T. Chongsuphajaisiddhi, D. M. Gordon, P. Suntharasamai, B. Permpanich, A. Brockman, P. Pitiuttutham, C. Wongsrichanalai, P. Srisuriya, B. Phonrat, K. Pavanand, C. Viravan, W. R. Ballou SPf66 malaria vaccine is safe and immunogenic in malaria naive adults in Thailand. Acta Tropica. Vol.67, No.3 (1997), 215-227. doi:10.1016/S0001-706X(97)00061-2 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/17961
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
SPf66 malaria vaccine is safe and immunogenic in malaria naive adults in Thailand
Abstract
In preparation for an efficacy trial of malaria vaccine SPf66 in Thailand, a series of overlapping Phase I trials were conducted of US- manufactured SPf66. Here, two clinical lots were evaluated for safety and immunogenicity in a combined open-label trial. Eleven healthy, malaria naive, 18-44 year-old Thai men and women received three doses by subcutaneous injection in alternate arms at 0, 1 and 6 months. Safety was assessed by monitoring local and systemic reactogenicity and laboratory parameters. Common side effects were mild erythema, induration and tenderness at the site of injection which resolved within 24-48 h. At third immunization, two volunteers developed acute bilateral reactions with induration, erythema and pruritus limited to the sites of the second and third immunizations. Eight of 11 volunteers sero-converted by ELISA, six of whom would be classified as high responders by Colombian standards. Eight of 11 volunteers developed a lymphoproliferative response to the SPf66 antigen. Side effects were more common and antibody and lymphoproliferative responses greatest, among the four female volunteers. This initial study of SPf66 malaria vaccine in Asia constitutes an essential link between the initial Phase I study in the US and subsequent field studies in a semi-immune population in a malaria endemic area of Thailand. This study further establishes comparability of US- manufactured SPf66 with that of Colombian provenance and substantiates the validity of the subsequent negative efficacy results of SPf66 in a field trial in Thailand.