Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT00312702
Status:
COMPLETED
Last Update Posted:
2018-11-26
First Post:
2006-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Sponsor:
U.S. Army Medical Research and Development Command
Organization:
Study Overview
Official Title:
A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS02A Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
Detailed Description:
* Controlled challenge, Phase I/IIa WRAIR study.
* Healthy, malaria-naive adults aged 18 - 50 years.
* 2 groups, 5 subjects in group A (10µg dose) and 15 subjects in group B (50µg dose).
* Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed.
* Vaccination schedule of 0, 1 months.
* Challenge of up to 15 subjects in Group B.
* Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine.
* Self-contained study.
* Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge).
* Data collection will be by done at the site.
* Healthy, malaria-naive adults aged 18 - 50 years.
* 2 groups, 5 subjects in group A (10µg dose) and 15 subjects in group B (50µg dose).
* Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed.
* Vaccination schedule of 0, 1 months.
* Challenge of up to 15 subjects in Group B.
* Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine.
* Self-contained study.
* Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge).
* Data collection will be by done at the site.
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 |
|---|---|---|---|---|
| HSRRB A-13732 | OTHER | USAMRMC | View |