MalariaNCT00341666
Immune Response Regulation in People Infected Concurrently With Malarial and Filarial Parasites
An observational study of Malaria and Filarial Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Malaria, Filarial Infection
- How many people
- 360 participants
- Where
- 1 siteMali
- Study dates
- 3 Apr 2006to 15 Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 1-8 years or age 18-65 years.
- Either resident of N'Tessoni (for active cohort) or resident of Bamako (for control cohort).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mali1 site
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako
About this study
Official title: 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.
Read more
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 collec...
Read the 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.
- Conditions
- Malaria, Filarial Infection
- Keywords
- Immune Regulation, Co-Infection, Filariasis, Immunology, Filarial Infection
- Medical subject headings
- Malaria, Coinfection, Filariasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start3 Apr 2006
- Study completion15 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341666
- Sponsor's protocol ID
- 999906135
- Other IDs
- 06-I-N135
- Status last verified
- 15 Jul 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
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. doi: 10.4269/ajtmh.2001.64.iv. No abstract available.
PubMed 11425185Gupta 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. doi: 10.1038/6560.
PubMed 10086393World 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. No abstract available. English, French.
PubMed 16316047
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Innate and Adaptive Immune Responses in Individuals Infected Concurrently With Malarial and Filarial Parasites
- ClinicalTrials.gov ID
- NCT00341666
- Acronym / sponsor ID
- 999906135
- Conditions
- Malaria, Filarial Infection
- Keywords
- Immune Regulation, Co-Infection, Filariasis, Immunology, Filarial Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 3 Apr 2006
- Study completion
- 15 Jul 2011
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 collec...
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.
Study design
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 1-8 years or age 18-65 years.
- Either resident of N'Tessoni (for active cohort) or resident of Bamako (for control cohort).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11425185Breman 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. doi: 10.4269/ajtmh.2001.64.iv. No abstract available.
- Background: PubMed 10086393Gupta 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. doi: 10.1038/6560.
- Background: PubMed 16316047World 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. No abstract available. English, French.
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Filarial Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341666, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.