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Efficacy of a Synthetic Vaccine Derived From Plasmodium Vivax Circumsporozoite Protein (PvCS) in naïve and Semi-immune Volunteers

NCT04739917 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-03-01

No results posted yet for this study

Summary

This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) vaccinated with three doses of a synthetic derivative of the CS protein of Plasmodium vivax to determine their protective efficacy.

Then volunteers will be subject to an infectious challenge (Controlled Human Malaria Infection) to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.

Conditions

  • Malaria, Vivax

Interventions

BIOLOGICAL

Vaccine PvCS N+C+R 150 mcg

Vaccine PvCS N+C+R 150 mcg (Montanide ISA-51), freeze dried powder.

OTHER

Placebo SSN Montanide ISA-51 1 mL

SSN Montanide ISA-51 1 mL

Sponsors & Collaborators

  • Malaria Vaccine and Drug Development Center

    lead OTHER

Principal Investigators

  • Sócrates Herrera, MD · Director

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-01
Completion
2022-12-01

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 NCT04739917 on ClinicalTrials.gov