Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Don gu Bougou, Mali

This study has been terminated.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341783
First received: June 19, 2006
Last updated: January 6, 2009
Last verified: July 2005
  Purpose

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, and/or stool tests not done at baseline will be done at one of the followup visits.


Condition
Malaria

Study Type: Observational
Official Title: Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Doneguebougou, Mali

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 515
Study Start Date: July 2002
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Males or females aged 6 months to 45 years.

Resident of Doneguebougou at the start of the study, and intent to remain a resident for the duration of the study.

Willingness to participate in the study as evidenced by the completed informed consent document.

EXCLUSION CRITERIA:

Clinical evidence of acute life-threatening illness requiring immediate medical care.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341783

Locations
United States, Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00341783     History of Changes
Other Study ID Numbers: 999902248, 02-I-N248
Study First Received: June 19, 2006
Last Updated: January 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Plasmodium
Falciparum
Screening
Malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 20, 2014