NCT02544048

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

Completed Last updated 17 December 2019

What this trial tests

trial in Malaria in 49 participants. Completed in 11 August 2017.

Timeline

4 September 2015

Primary endpoint
4 September 2015

11 August 2017

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	49
Start date	4 September 2015
Primary completion	4 September 2015
Estimated completion	11 August 2017
Sites	1 location across Mali

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 50, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

...

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.