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Immune Response Regulation in People Infected Concurrently With Malarial and Filarial Parasites

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00341666
  Purpose

This study, conducted by NIH and the University of Bamako in Mali, Africa, will study the effect of concurrent infections with malaria and filariasis on patients' immune response. Lymphatic filariasis is caused by infection with very small parasitic worms called Wuchereria bancrofti that are acquired from mosquitoes. The worms may cause no illness in many who are infected, but is some, they can cause swelling of the arms, legs, breast and genitalia, which may progress to permanent swelling referred to as elephantiasis. Malaria is caused by Plasmodium falciparum, another parasite that is spread by mosquitoes. It can cause fevers, headaches, body aches and weakness, and, if untreated, it can cause severe illness and death.

The 8-month study will analyze measures of immune function in blood cells from people with or without filarial infections who become infected with malaria. The goal of the studies is to see if having a filarial worm infection affects immunity against malaria. Results of analysis of immune function in persons with malaria but without filaria infections will be compared with those harboring both filaria and malaria infections and also with results from healthy control subjects.

Healthy individuals and patients with malaria and filarial infections between 1 and 8 years of age and between 18 to 65 years of age who live in N'Tessoni and healthy individuals living in Bamako, Mali (controls), may be eligible for this study.

Participants have blood samples collected as follows during the study:

  • A blood sample will be collected at the beginning of the study. Individuals found to have the filarial worm infection have a second sample drawn at nighttime when the filarial worms are present in the blood. Treatment for filaria infection will be offered to all infected individuals at the end of the study.
  • A second sample will be collected during malaria season. Subjects will be interviewed about their health during the malaria season and re-tested for filarial and malaria infections with a finger-prick test. Those who test positive for malaria will be offered treatment to begin immediately after collection of the donated blood sample..
  • A third sample will be collected after the end of the malaria season. Subjects will be interviewed again about their health and re-tested for filarial and malaria infections with a finger prick test. Those who have positive results for either infection will be offered treatment after collection of the donated blood sample

Some of the blood collected will be used for genetic tests and some will be frozen for study at a later time.


Condition
Malaria
Filarial Infection

MedlinePlus related topics:   Malaria   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Regulation of Innate and Adaptive Immune Responses in Individuals Infected Concurrently With Malarial and Filarial Parasites

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   360
Study Start Date:   April 2006

Detailed Description:

Residents of malaria-endemic regions are frequently exposed to a variety of other parasites concurrently with malarial parasites. In Mali, lymphatic filariasis co-exists in several regions highly endemic for malaria. Because of the chronicity of filarial infections and an associated bias towards the development of an adaptive immune response dominated by Th2 cytokines, a pre-existing filarial infection has the potential to alter the immune response towards incoming malarial parasites, clearance of which are considered to be dependent on a robust Th1 response. Conversely, immune responses to filarial parasites may be modulated in the presence of malarial parasites. The goal of this study is to determine the effect of concurrent infections with malarial and filarial parasites on innate and adaptive immune responses to homologous and heterologous antigens. We will characterize the responses of peripheral blood mononuclear cells to antigens derived from both filarial (Wuchereria bancrofti) and malarial (Plasmodium falciparum) parasites in groups of individuals with or without filarial infections and follow them through a malaria transmission season, when they are repeatedly exposed to malarial parasites, to determine how co-infection with the filarial parasite affects the cellular and humoral responses to malarial and filarial antigens. These studies may provide the basis for modifying treatment strategies of mass treatment of malaria in regions co-endemic for lymphatic filariasis.

  Eligibility
Ages Eligible for Study:   1 Year to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria
  • INCLUSION CRITERIA:

Age 1-8 years or age 18-65 years.

Either resident of N'Tessoni (for active cohort) or resident of Bamako (for control cohort).

EXCLUSION CRITERIA:

Pregnancy (for the adult cohort).

Hemoglobin less than or equal to 8g/dl.

Symptoms of malaria with any level of parasitemia.

Recent history or clinical evidence of prostration, bleeding, respiratory distress, seizures, coma or obtundation, jaundice, inability to drink, persistent vomiting.

History of allergy to sulfa or pyrimethamine-sulfadoxine.

Plans to relocate outside the immediate village vicinity during the study period.

Clinical evidence of severe and/or chronic illness as determined by the examining physician.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00341666

Locations
Mali
University of Bamako, Faculty Med Pharmacy & Dentistry    
      Bamako, Mali

Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information


Publications:
Breman JG, Egan A, Keusch GT. The intolerable burden of malaria: a new look at the numbers. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):iv-vii. No abstract available.
 
Gupta S, Snow RW, Donnelly CA, Marsh K, Newbold C. Immunity to non-cerebral severe malaria is acquired after one or two infections. Nat Med. 1999 Mar;5(3):340-3.
 
World Health Organization. Sixth meeting of the Technical Advisory Group on the Global Elimination of Lymphatic Filariasis, Geneva, Switzerland, 20-23 September 2005. Wkly Epidemiol Rec. 2005 Nov 18;80(46):401-8. English, French. No abstract available.
 

Study ID Numbers:   999906135, 06-I-N135
First Received:   June 19, 2006
Last Updated:   September 19, 2008
ClinicalTrials.gov Identifier:   NCT00341666
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immune Regulation  
Co-Infection  
Filariasis  
Immunology  
Filarial Infection  

Study placed in the following topic categories:
Filariasis
Malaria

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 15, 2008

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