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

This study has been completed.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Medical Biotech Laboratories
University Of Perugia
Imperial College London
Microtest Matrices Ltd
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01214876
First received: October 4, 2010
Last updated: March 3, 2011
Last verified: August 2010

October 4, 2010
March 3, 2011
August 2010
March 2011   (final data collection date for primary outcome measure)
Immune correlates of protection against clinical malaria episodes with plasmodium falciparum [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01214876 on ClinicalTrials.gov Archive Site
  • Geographical patterns in malaria morbidity [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    ASYMPTOMATIC PARASITE CARRIAGE will be confirmed by microscopy and PCR.
Same as current
Not Provided
Not Provided
 
Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma samples Human DNA samples Parasite DNA samples

Probability Sample

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

  • Malaria
  • Schistosomiasis
  • Hiv Infection
Not Provided
  • Children 1-5 years old
  • Children 6-10 years old
  • Adults 25 years and above
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
1 Year and older
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01214876
FIGHTMAL
No
Teun Bousema, London School of Hygiene & Tropical Medicine
Radboud University
  • London School of Hygiene and Tropical Medicine
  • Medical Biotech Laboratories
  • University Of Perugia
  • Imperial College London
  • Microtest Matrices Ltd
Not Provided
Radboud University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP