Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires

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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

, ,

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

, ,

Verification Date

August 2010