Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-01 @ 2:25 PM
Study NCT ID:
NCT02458092
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
Sponsor:
U.S. Army Medical Research and Development Command
Organization:
Study Overview
Official Title:
Phase 1b Controlled Double Blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With Glaxo Smith Kline (GSK) Biologicals' Adjuvant AS01B
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| WRAIR 1417 | OTHER | Walter Reed Army Institute of Research | View |