Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341783
Status:
TERMINATED
Last Update Posted:
2009-01-07
First Post:
2006-06-19
Brief Title:
Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Don gu Bougou Mali
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Doneguebougou Mali
Status:
TERMINATED
Status Verified Date:
2005-07
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:
There are about 300-500 million cases of malaria worldwide each year with 2-3 million deaths Plasmodium falciparum one of four types of malaria is responsible for most of these deaths Because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides a vaccine would be valuable in the fight against malaria
Don gu bougou Mali is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines The goal of this study is to characterize the population of this site in terms of common hematologic blood and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy Also the natural immunity to antigens in the investigational malaria vaccines will be determined
Don gu bougou Mali was chosen because of its high malaria rates Data will be collected at four time-points At least 50 individuals will be recruited from each of the following age groups 6 months-5 years 6-10 years 11-15 years and 16-45 years Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected Individual consent will also be obtained
Enrolled volunteers will undergo a baseline medical history and physical examination Blood will be collected for various tests and for women of childbearing age urine pregnancy tests will be administered
At each of three followup visits a brief medical history and physical exam will be conducted Blood will be drawn for tests Also blood urine andor stool tests not done at baseline will be done at one of the followup visits
Don gu bougou Mali is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines The goal of this study is to characterize the population of this site in terms of common hematologic blood and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy Also the natural immunity to antigens in the investigational malaria vaccines will be determined
Don gu bougou Mali was chosen because of its high malaria rates Data will be collected at four time-points At least 50 individuals will be recruited from each of the following age groups 6 months-5 years 6-10 years 11-15 years and 16-45 years Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected Individual consent will also be obtained
Enrolled volunteers will undergo a baseline medical history and physical examination Blood will be collected for various tests and for women of childbearing age urine pregnancy tests will be administered
At each of three followup visits a brief medical history and physical exam will be conducted Blood will be drawn for tests Also blood urine andor stool tests not done at baseline will be done at one of the followup visits
Detailed Description:
Doneguebougou Mali is an area of seasonal malaria transmission that is being investigated as a suitable site for testing investigational malaria vaccines The overall goal of this study is to characterize the population of this site in terms of common hematologic and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials as well as in terms of preexisting medical conditions and preexisting immunity to potential malaria vaccine antigens both of which might impact on the assessment of vaccine safety and efficacy The development of high quality laboratory proficiency to assess these parameters in Mali will also be achieved by this study
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 |
|---|---|---|---|
| 02-I-N248 | None | None | None |