Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults

NCT02544048 | Completed

• 2 other identifiers: 99991519715-I-N197
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Background: People with malaria often show altered immune responses to many illnesses and vaccines. This means that the malaria might cause immune suppression. It is not clear how or which vaccines are impacted by malaria. It is also not clear if the impacts are such that people should be preemptively treated before they get vaccinations. Researchers want to see if there is a link between taking an antimalaria drug prior to getting vaccines and the immune response to those vaccines. To do this, they will study people who are taking part in certain NIAID studies. Objectives: To compare the proportion of PD1+ CD4 T cells among all T cells in vaccine immune responses in adults who have or have not received antimalarials prior to getting a Menactra vaccine. Eligibility: Healthy Malian adults who: Were previously enrolled in NIAID Protocol 13-I-N109 or 15-I-0044 Reside in Bancoumana and neighboring villages Are not pregnant Design: Participants will be screened with a physical exam. Participants will get the vaccines listed below as part of Protocol 13-I-N109 or 15-I-0044. This study will follow their schedule. At each visit, participants will give a blood sample. They will also have a physical exam. Each visit will last 1 to 2 hours. At visit 1, participants will get a hepatitis vaccine. Two weeks later, participants may get the antimalarial drug Coartem . They will be chosen at random. Two weeks later, participants will get Menactra . Participants will have 5 follow-up visits after they get Menactra . The study will last up to 4 months. ...

Conditions

Malaria

Keywords

Immune; Parasitemia; Menactra; Polymerase Chain Reaction (PCR); Coartem

Outcome Measures

Primary Outcomes (1)

• Proportion of T cells expressing PD-1 among all T cells on Study Day 42

  Study Day 42

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Known to be pregnant (by history)
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, psychiatric, or renal disease by history and/or physical examination
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
• Prior to Study Day 0, receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks
• Use of chronic (greater than or equal to 14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (eg, prednisone \> 10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0
• Known allergies or contraindications to study treatment (Coartem \[artemether//lumefantrine\]) or vaccines (Euvax B or TWINRIX and Menactra )
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol

Sponsors & Collaborators

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

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

• Williamson WA, Greenwood BM. Impairment of the immune response to vaccination after acute malaria. Lancet. 1978 Jun 24;1(8078):1328-9. doi: 10.1016/s0140-6736(78)92403-0.

  PMID: 78096 BACKGROUND

• 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

• Greenwood BM, Bradley-Moore AM, Bryceson AD, Palit A. Immunosuppression in children with malaria. Lancet. 1972 Jan 22;1(7743):169-72. doi: 10.1016/s0140-6736(72)90569-7. No abstract available.

  PMID: 4109547 BACKGROUND

MeSH Terms

Conditions

Malaria; 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

• Sara A Healy, M.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: September 5, 2015
• First Posted: September 9, 2015
• Study Start: September 4, 2015
• Primary Completion: September 4, 2015
• Study Completion: August 11, 2017
• Last Updated: December 17, 2019

Record last verified: 2017-08-11

Locations

MA (1)