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Safety and Immunogenicity Study of Plasmodium Vivax CS Derived Synthetic Peptides Formulated in Two Adjuvants

NCT01081847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-03-08

No results posted yet for this study

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)

Conditions

  • Malaria, Vivax

Interventions

DRUG

Peptides (N,R&C) formulated in Montanide ISA 720

50 ug

DRUG

Peptides (N,R&C) formulated in Montanide ISA 51

50 ug

DRUG

Peptides (N,R&C) formulated in Montanide ISA 720

100 ug

DRUG

Peptides (N,R&C) formulated in Montanide ISA 51

100 ug

OTHER

Placebo

PLacebo: Isotonic saline solution

Sponsors & Collaborators

  • Centro médico Imbanaco

    collaborator UNKNOWN

  • Asoclinic Inmunología Ltda.

    collaborator INDUSTRY

  • Malaria Vaccine and Drug Development Center

    lead OTHER

Principal Investigators

  • Myriam Arevalo-Herrera, PhD · MVDC

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-03-31
Completion
2006-04-30

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01081847 on ClinicalTrials.gov