A Trial For The Study of Falciparum Malaria Protein 014 Administered Via Intramuscular Injection in Healthy Adults
NCT04296279 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2021-04-19
Summary
A Phase 1, open label clinical study to evaluate the safety, immunogenicity, tolerability and efficacy of Plasmodium falciparum Malaria Protein 014 (FMP014) 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
-
FMP014
Falciparum Malaria Protein-14
- 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
- 2021-12-31
- Completion
- 2022-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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