Malaria, Vivax Clinical Trial
Official title:
Malaria Vaccine Phase IB Clinical Trial: Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants
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)
The study corresponds to a clinical trial, randomized double-blind, controlled, dose
escalation, Phase IB, which will assess the safety and immunogenicity of a mixture of
synthetic peptides derived from CS protein of P. vivax, formulated in adjuvant Montanide ISA
720 and 51; in healthy men and nonpregnant women without previous history of malaria
infection.
In order to optimize the vaccine dose, eligible participants were enrolled to receive three
doses of vaccine containing peptide mixtures at a dose of 50 ug or 100 ug of each individual
peptide, for a final dose of 150 ug or 300 ug respectively, in a volume of 0.5 mL. The
previous clinical trial had indicated that doses between 30 ug and 100 ug produced better
responses than lower doses. The first immunization dose (given at Month 0) contained the
peptides N and C only, whereas the two boosting doses (given at Months 2 and 4) contained
all three (N, R, and C) peptides (Table 1). Vaccination was performed by intramuscular
injection in the deltoid muscle, alternating arms with each injection.
For safety reasons, participants assigned to the low vaccine dose groups were immunized
first and only two weeks after initiation when no serious adverse events (SAE) had occurred,
immunization of participants in the high-dose was started. Half of the participants assigned
to receive placebo were immunized along with each dose level group. Clinical monitors and
the IRBs of the University of Valle and IMC, evaluated the occurrence and severity of
adverse events (AE) associated with immunization. The occurrence of more than three AE
(severity grade 2 or higher) or one SAE related to the vaccine would have led to study
termination. Participants who left the study were not replaced.
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Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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