Brief Title
Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
Brief Summary
A longitudinal study on immune responses in relation to protection against clinical malaria
episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited:
children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and
above (n=125). After finger prick sampling (~300µL) and examination at enrolment,
participants will be followed up for one year. Follow-up will include fortnightly active case
detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the
associated clinical and parasitological parameters will be related to immunological profiles
determined utilizing a protein microarray as a capture substratum to profile the humoral
immune response against a vast number of parasite antigens.
For individuals who experience a clinical malaria attack or who are diagnosed with high
density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood
sample is obtained to determine the diversity of parasite antigens in the population in
relation to antigen recognition in the cohort.
Study Type
Observational
Primary Outcome
Immune correlates of protection against clinical malaria episodes with plasmodium falciparum
Secondary Outcome
Geographical patterns in malaria morbidity
Condition
Malaria
Study Arms / Comparison Groups
Children 1-5 years old
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
500
Start Date
August 2010
Completion Date
March 2011
Primary Completion Date
March 2011
Eligibility Criteria
Inclusion Criteria:
- age 1-5 years, 6-10 years or 25 yearsand above
- written informed consent must be given
- the individual must have been resident of the area since birth or for a minimum period
of two years
- the individual must be willing to submit required information and to participate in
repeated sampling (total blood volume ~2.5 mL over a period of 12 months)
- Absence of danger signs (as defined by WHO) or clinical features of AIDS. An HIV-test
will be offered to all participants at enrolment and completion of the study.
Exclusion Criteria:
- unwillingness to sign consent form
- unwillingness to reside in the study area during the follow-up period
Gender
All
Ages
1 Year - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Uganda
Location Countries
Uganda
Administrative Informations
NCT ID
NCT01214876
Organization ID
FIGHTMAL
Study Sponsor
Radboud University
Collaborators
London School of Hygiene and Tropical Medicine
Study Sponsor
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Verification Date
August 2010