Markers of T Cell Suppression: Associations With Malaria Infection and Antimalarial Treatment in Malian Children

NCT02504918 | Completed

• 2 other identifiers: 99991516315-I-N163
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The disease malaria can cause very serious health problems. Researchers want to see if malaria affects the way T cells and vaccines work in the body. If it does, they may need to give malaria treatments before vaccines. They want to check the T cells in children who do or do not get antimalarial treatment. Objectives: \- To study the effect of blood stage malaria on T cell suppression and vaccine responses. To describe markers of T cell suppression in children who do or do not receive antimalarial treatment. Eligibility: \- Children ages 12 59 months living near Ouelessebougou in Mali. They must have no serious illness. Design:

• Participants will be screened with medical history and physical exam.
• Some participants will get a course of antimalarial tablets. Some will not. This will be decided at random.
• Participants will have monthly visits for up to a year. They will have blood tests at each visit.

Conditions

Malaria

Keywords

Plasmodium Falciparum; Regulatory; Chemoprevention; Coartem; Parasitemia

Outcome Measures

Primary Outcomes (2)

• To investigate the association of recent malaria infection and percentage of PD1+ CD4 T cells in children that have not received SMC during the rainy season.

  Approximately 3-6 months

• To compare the percentage of PD1 +CD4 T cells in children who do or do not receive antimalarial treatment, in both rainy season and drythedry season.

  Approximately 3-6 months

Secondary Outcomes (3)

• To compare and describe levels of regulatory T cells in children who do or do not receive antimalarial treatment, in both rainy season and dry season. To compare and describe T cell stimulation responses in children who do or do not receive anti...

  Approximately 3-6 months

• To determine and investigate phenotypic differences in T cell subsets in infected and uninfected subjects at baseline.

  Approximately 3-6 months

• To confirm that blood stage parasite burden is markedly reduced throughout the dry season by a single treatment with artemether-lumefantrine at enrollment; and to examine the association of parasite clearance during the dry season on malaria ris...

  Approximately 3-6 months

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• A study participant must satisfy the following criteria to be enrolled in this study:
• A child between 12-59 months
• Parent/guardian able to provide consent
• Resident of the health district of Ouelessebougou or neighboring district for at least a year

You may not qualify if:

• Clinically symptomatic or apparent severe anemia or any other condition that may be worsened by 5 mL phlebotomy or any other study procedure
• Chronic or debilitating condition that precludes attendance for monthly visits
• Known or clinically apparent condition of immunosuppression or chronic infection.
• Known allergies to study treatments (SP; amodiaquine; artemether-lumefantrine)
• Use of cotrimaxozale on a routine basis for prophylaxis
• Conditions that in the judgment of the investigator could increase the risk to the volunteer.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ouelessebougou Clinical Research Center MRTC/ FMPOS

Wolossébougou, Mali

Location

Related Publications (4)

• Cunnington AJ, Riley EM. Suppression of vaccine responses by malaria: insignificant or overlooked? Expert Rev Vaccines. 2010 Apr;9(4):409-29. doi: 10.1586/erv.10.16.

  PMID: 20370551 BACKGROUND

• Dicko A, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Diawara H, Conare T, Djimde A, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Mali: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000407. doi: 10.1371/journal.pmed.1000407.

  PMID: 21304923 BACKGROUND

• Wilson AL; IPTc Taskforce. A systematic review and meta-analysis of the efficacy and safety of intermittent preventive treatment of malaria in children (IPTc). PLoS One. 2011 Feb 14;6(2):e16976. doi: 10.1371/journal.pone.0016976.

  PMID: 21340029 BACKGROUND

• Attaher O, Zaidi I, Kwan JL, Issiaka D, Samassekou MB, Cisse KB, Coulibaly B, Keita S, Sissoko S, Traore T, Diarra K, Diarra BS, Dembele A, Kanoute MB, Mahamar A, Barry A, Fried M, Dicko A, Duffy PE. Effect of Seasonal Malaria Chemoprevention on Immune Markers of Exhaustion and Regulation. J Infect Dis. 2020 Jan 1;221(1):138-145. doi: 10.1093/infdis/jiz415.

  PMID: 31584094 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Parasitemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michal Fried, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: July 21, 2015
• Primary Completion: December 31, 2016
• Study Completion: June 12, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06-12

Locations

MA (1)