Immune Response Regulation in People Infected Concurrently With Malarial and Filarial Parasites
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||July 16, 2011|
|Start Date ICMJE||April 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00341666 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Immune Response Regulation in People Infected Concurrently With Malarial and Filarial Parasites|
|Official Title ICMJE||Regulation of Innate and Adaptive Immune Responses in Individuals Infected Concurrently With Malarial and Filarial Parasites|
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:
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||360|
|Completion Date||July 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age 1-8 years or age 18-65 years.
Either resident of N'Tessoni (for active cohort) or resident of Bamako (for control cohort).
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.
|Ages||1 Year to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Mali|
|NCT Number ICMJE||NCT00341666|
|Other Study ID Numbers ICMJE||999906135, 06-I-N135|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP