Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants
Status:
Completed
Trial end date:
2006-04-01
Target enrollment:
Participant gender:
Summary
This was a phase I double blind controlled vaccine trial, evaluating safety, tolerability and
immunogenicity of mixtures of N, R and C LSP derived from the P. vivax CS protein formulated
in two adjuvants Montanide ISA 720 and Montanide ISA 51.
The primary objective was to assess in malaria-naïve adults, the safety and reactogenicity of
these peptides formulated in the two adjuvants
We recruited 40 healthy men and women volunteers from Cali, Colombia, a city non-endemic for
malaria. Volunteers were 19--41 years of age and had no history of malaria. During a period
of three months a total of 100 volunteers were assessed for eligibility criteria in order to
select a total of 40 volunteers willing to participate in the clinical trial. By consecutive
allocation, eight participants were allocated to each of the five experimental groups (A--E):
four groups (A--D) were immunized with the vaccine formulations at two different dose
concentrations and formulated in two different adjuvants. A control group (E) was injected
with placebo (saline solution)
Phase:
Phase 1
Details
Lead Sponsor:
Malaria Vaccine and Drug Development Center
Collaborators:
Asoclinic Inmunología Ltda. Centro médico Imbanaco