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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02544048
• Date of registration: 05/09/2015
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
• Scientific title: Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
• Date of first enrolment: September 4, 2015
• Target sample size: 49
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02544048
• Study type: Observational

Countries of recruitment

Mali

Contacts

• Name: Sara A Healy, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion criteria

- INCLUSION

- Enrolled, completed unblinding, and have opted to receive the comparator vaccines in
either NIAID Protocol 13-I-N109 or 15-I-0044

- In good general health and without any clinically significant medical history

- Willing to have blood samples stored for future research

- Known resident of Bancoumana or surrounding area

EXCLUSION

- 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Primary Outcome(s)

Proportion of T cells expressing PD-1 among all T cells on Study Day 42 [Time Frame: Study Day 42]

Secondary ID(s)

999915197

15-I-N197

Source(s) of Monetary Support

Please refer to primary and secondary sponsors