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A Trial For The Study of Falciparum Malaria Protein 013 Administered Via Intramuscular Injection in Healthy Adults

NCT04268420 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-01-10

No results posted yet for this study

Summary

A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 013 (FMP013) combined with (ALF with QS-21), saponin molecule derived from the bark of Quillaja species (ALFQ)) in healthy adult volunteers at different doses and dosing schedules.

Conditions

  • Vaccine Reaction

Interventions

DRUG

FMP013

Falciparum Malaria Protein-13

DRUG

ALFQ

ALF with QS-21, saponin molecule derived from the tree bark of Quillaja species

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-03-20
Primary Completion
2023-07-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

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 NCT04268420 on ClinicalTrials.gov