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Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B

NCT02458092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-28

Study results available
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Summary

The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.

Conditions

Interventions

BIOLOGICAL

Plasmodium falciparum Malaria Protein 010 (FMP010)

Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK

BIOLOGICAL

Rabipur

Rabipur is a licensed rabies vaccine.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • United States Agency for International Development (USAID)

    collaborator FED

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Kenya Medical Research Institute

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Nekoye Otsyula · US Army Medical Research Unit - Kenya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2009-06-30

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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 NCT02458092 on ClinicalTrials.gov