Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197054
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2005-09-13
Brief Title:
Safety Immunogenicity of RTSSAS02A and RTSSAS01B Malaria Vaccines in Malaria-experienced Adults
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase IIb Randomized Double-blind Controlled Study of the Safety Immunogenicity and Proof-of-concept of RTSSAS02A and RTSSAS01B Two Candidate Malaria Vaccines in Malaria-experienced Adults Living in Western Kenya
Status:
COMPLETED
Status Verified Date:
2021-02
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 candidate malaria vaccine RTSSAS02A developed by GSK Biologicals demonstrated 30 efficacy against clinical episodes of malaria and approximately 58 efficacy against severe malaria disease As a potential improvement to RTSSAS02A another candidate vaccine RTSSAS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research WRAIR This study will be the first administration of the RTSSAS01B vaccine to the African adults to establish safety and immunogenicity in this population Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum
Detailed Description:
The study comprises of 3 groups and the participating subjects will be randomly allocated to one of the three groups The first group will receive RTSSAS01B the second group will receive RTSSAS02A and the third group will receive rabies vaccine Immunization will be given by IM injection on 0 1 2 month schedule Infants will be followed up daily for 7 days for solicited symptoms and 30 days for unsolicited symptoms after each vaccine dose Serious adverse events will be recorded throughout the study period A week prior to Dose 3 subjects will be treated with a licenced anti-malarial drug Starting from two weeks after Dose 3 the subjects will be monitored for a 14-week duration for detection of malaria infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 11220 | OTHER | FDA | None |