Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00358332
Status:
COMPLETED
Last Update Posted:
2011-10-24
First Post:
2006-07-27
Brief Title:
Phase I Pediatric FMP21AS02A Trial in Mali
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Randomized Controlled Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of WRAIRs AMA-1 Malaria Vaccine FMP21 Adjuvanted in GSKBios AS02A Vs Rabies Vaccine in 1-6 Year Old Children in Bandiagara Mali
Status:
COMPLETED
Status Verified Date:
2011-10
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 test the safety and dosages of a malaria vaccine in 100 children 1-6 years old in Bandiagara Mali The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved During the study the childs health will be checked in the clinic and during home visits Children may participate for about 14 months and blood will be taken from each child throughout the study If the child becomes sick from malaria heshe will be treated Information from this study may be used to develop a malaria vaccine that will help control the disease
Detailed Description:
This study is a randomized controlled dose-escalation phase I trial of the FMP21AS02A malaria vaccine using rabies vaccine as a control This study is linked to DMID protocol 07-0003 The primary objective of this study is to evaluate the safety and reactogenicity of FMP21AS02A in children naturally exposed to P falciparum malaria infection The secondary objective is to measure the magnitude and duration of antibody response to FMP21 by enzyme-linked immunosorbent assay ELISA One hundred healthy children aged 1-6 years in Bandiagara Mali will be randomized to 1 of 3 possible groups Twenty subjects will be enrolled in cohort 1 and 40 subjects each in cohorts 2 and 3 Children within each cohort will be randomized in a 31 ratio to receive 10 25 or 50 micrograms of FMP21 in cohorts 1 2 and 3 respectively adjuvanted with a proportionate volume of the AS02A or rabies vaccine Thus a total of 75 children will receive the malaria vaccine and 25 the rabies vaccine Immunizations will be given on days 0 30 and 60 in a staggered fashion with the first administrations of the 25 and 50 microgram dose levels of FMP21 following the first administration of the 10 and 25 microgram dose levels respectively by 2-3 weeks Solicited adverse events will be recorded on the days of immunization and days 1 2 3 and 7 after each immunization and unsolicited adverse events will be recorded for 30 days after each immunization Children will be followed for 1 year after the last immunization Sera will be collected for anti-FMP21 antibody titers on the days of immunization and 14 days after each immunization as well as 3 6 9 and 12 months after the first immunization Each child will participate in the study for up to 414 days which includes the screening period The primary outcome measures include occurrence of solicited symptoms after each vaccination during a 7-day surveillance period day of vaccination and days 1 2 3 and 7 after vaccination occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period day of vaccination and 30 subsequent days and occurrence of serious adverse events throughout the study period The secondary outcome measure is titers and activity of anti-FMP21 antibody at each time point where serology samples are analyzed measured by ELISA
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 |
|---|---|---|---|
| GSKBio Malaria 051 106874 | US NIH GrantContract | None | httpsreporternihgovquickSearch2U01AI065683-06 |
| U19AI065683 | NIH | None | None |
| 2U01AI065683-06 | NIH | None | None |