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

March 3, 2011 updated by: Radboud University Medical Center

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Medical Biotech Laboratories

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Randomly selected individuals living in Abedi, Apac District, Uganda.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children 1-5 years old
Children 6-10 years old
Adults 25 years and above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Immune correlates of protection against clinical malaria episodes with plasmodium falciparum

IMMUNE RESPONSES: protein array.

CLINICAL MALARIA EPISODES: (reported) fever with i) P. falciparum parasites; ii) ... at a density >=5,000 parasites/ul; iii) ... at a density >=10,000 parasites/ul IMMUNOLOGICALLY PROTECTED INDIVIDUALS: parasitaemic during follow-up without reporting to the health facility with indicators of a clinical malaria episode

Secondary Outcome Measures

Outcome Measure
Measure Description
Geographical patterns in malaria morbidity
Households are geo-located by GPS and hotspots of malaria transmission will be determined and related to serological profiles.
Asymptomatic parasite carriage and immune responses in different age-groups exposed to intense malaria transmission
ASYMPTOMATIC PARASITE CARRIAGE will be confirmed by microscopy and PCR.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

London School of Hygiene and Tropical Medicine
Imperial College London
University Of Perugia
Medical Biotech Laboratories
Microtest Matrices Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (Estimate)

October 5, 2010

Study Record Updates

Last Update Posted (Estimate)

March 4, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIGHTMAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malaria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe