Malaria Clinical Trial
Official title:
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Verified date | August 11, 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
...
Status | Completed |
Enrollment | 49 |
Est. completion date | August 11, 2017 |
Est. primary completion date | September 4, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
- 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 |
Country | Name | City | State |
---|---|---|---|
Mali | Malaria Research and Training Center | Bamako |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
Mali,
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. Review. — View Citation
Greenwood BM, Bradley-Moore AM, Bryceson AD, Palit A. Immunosuppression in children with malaria. Lancet. 1972 Jan 22;1(7743):169-72. — View Citation
Williamson WA, Greenwood BM. Impairment of the immune response to vaccination after acute malaria. Lancet. 1978 Jun 24;1(8078):1328-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of T cells expressing PD-1 among all T cells on Study Day 42 | Study Day 42 |
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