PMID: 9180603May 1, 1997Paper

Phase I trial of the SPf66 malaria vaccine in a malaria-experienced population in Southeast Asia

The American Journal of Tropical Medicine and Hygiene
F NostenD G Heppner

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-adsorbed 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-linked immunosorbent assay occurred in 76% of volunteers receiving two or three doses. This vaccine...Continue Reading

Citations

Jul 20, 2007·The Cochrane Database of Systematic Reviews·P Graves, H Gelband
Apr 21, 2006·The Cochrane Database of Systematic Reviews·P Graves, H Gelband
May 18, 2006·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·F Ellis McKenzieRobert A Gasser

❮ Previous
Next ❯

Related Concepts

Related Feeds

Antimalarial Agents

Antimalarial agents, also known as antimalarials, are designed to prevent or cure malaria. Discover the latest research on antimalarial agents here.

Antimalarial Agents (ASM)

Antimalarial agents, also known as antimalarials, are designed to prevent or cure malaria. Discover the latest research on antimalarial agents here.