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CompletedNCT01214876Updated Mar 4, 2011

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

An observational study in Malaria, Schistosomiasis and Hiv Infection, sponsored by Radboud University Medical Center. Completed at 1 site in Uganda. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-04.

Sponsored by Radboud University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
1 Year and older
Sex
All
01

Study 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.

02

Conditions studied

  • Malaria
  • Schistosomiasis
  • Hiv Infection
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's planned enrollment of 500 is below the median of 600 across 218 observational studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • unwillingness to sign consent form
  • unwillingness to reside in the study area during the follow-up period
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Children 1-5 years old
  • Children 6-10 years old
  • Adults 25 years and above
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Geographical patterns in malaria morbidity

    Households are geo-located by GPS and hotspots of malaria transmission will be determined and related to serological profiles.

  2. 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.

07

Study locations

1 site
  • Medical Biotech Laboratories
    Kampala, Uganda
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01214876
Lead sponsor
Radboud University Medical Center
Collaborators
London School of Hygiene and Tropical Medicine, Medical Biotech Laboratories, University Of Perugia, Imperial College London, Microtest Matrices Ltd
First posted
Oct 5, 2010
Start date
Aug 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Mar 4, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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