Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385047
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2006-10-04
Brief Title:
A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe Protective Against Malaria in Adults
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Phase IIIa Study of the Safety Immunogenicity and Preliminary Efficacy After Sporozoite Challenge of FMP21AS01B and FMP21AS02A Candidate Malaria Vaccines Administered Intramuscularly at Months 0 1 and 2 in Malaria-naive Adults Living in the United States
Status:
COMPLETED
Status Verified Date:
2015-06
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 2 investigational malaria vaccines are safe as well as protective against malaria in adults living in the United States
Detailed Description:
35 volunteers aged 18 to 50 years will be enrolled to receive one of 2 investigational malaria vaccines The vaccines are made of a malaria protein FMP21 mixed in 2 different adjuvants AS01B and AS02A Five volunteers will get a small 10 µg dose of FMP21AS01B since this vaccine has not yet been in humans If it is safe then 15 volunteers will get 50 µg FMP21 in AS02A and 15 will get 50 µg FMP21 in AS01B All vaccines are given IM in the deltoid of the non-dominant arm every 1 month for 3 months After vaccination the subjects will follow up at clinical trials for evaluation of any adverse events
20 vaccinees 10 from each 50 µg vaccine group will undergo primary sporozoite challenge 14-30 days after dose 3 via bite of 5 malaria-infected mosquitoes All subjects will have a blood slide prepared and read to check for asexual P falciparum parasitemia at least once daily beginning day 5 post challenge Beginning on day 10 post challenge subjects will check into a designated hotel where 24 hour evaluation and care will be available for 10 nights After this hotel phase there will be follow-up visits to ensure there are no late developments of malaria in those who have not fallen ill and thus are considered protected
Any subject who tests positive for malaria will be treated with chloroquine Efficacy readouts are complete protection or significant delay in patency defined as 2 days than the median prepatent period for the 6 infectivity controls These 6 controls receive no vaccine and are enrolled for malaria-challenge only in order to provide comparison group for vaccinated individuals
20 vaccinees 10 from each 50 µg vaccine group will undergo primary sporozoite challenge 14-30 days after dose 3 via bite of 5 malaria-infected mosquitoes All subjects will have a blood slide prepared and read to check for asexual P falciparum parasitemia at least once daily beginning day 5 post challenge Beginning on day 10 post challenge subjects will check into a designated hotel where 24 hour evaluation and care will be available for 10 nights After this hotel phase there will be follow-up visits to ensure there are no late developments of malaria in those who have not fallen ill and thus are considered protected
Any subject who tests positive for malaria will be treated with chloroquine Efficacy readouts are complete protection or significant delay in patency defined as 2 days than the median prepatent period for the 6 infectivity controls These 6 controls receive no vaccine and are enrolled for malaria-challenge only in order to provide comparison group for vaccinated individuals
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20060900 | OTHER | Internal | None |
| A-13949 | OTHER | None | None |
| ETrack Protocol No 104936 | OTHER | None | None |
| MAL-045 | OTHER | None | None |