drugset / Trial / NCT03175380

Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US

NCT03175380

Phase 0 Completed 15 enrolled Aeras
NaSingle-groupOpen-labelBasic science

Summary

This protocol will use leukapheresis to collect lymphocytes to study immune responses following vaccination with BCG in BCG-naïve participants. These studies will include, but not necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses, anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses will provide a detailed framework characterizing the immune responses that are induced and responses that are not induced in humans by BCG, a partially protective TB vaccine. This framework will allow new hypotheses to be formulated and tested regarding what new and more effective TB vaccines should target for optimal protective immunity.

Timeline

Start
2017-08-08
Primary completion
2019-01-10
Completion
2019-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bacillus Calmette-Guérin Vaccine Intramuscular

Indications