NCT03175380

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

Collection and Storage of Biological Samples Obtained by Leukapheresis for the Future Study of Immune Responses Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US (A-051)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label protocol in up to 15 healthy adults who are BCG-naïve. All participants will receive a total of two doses of BCG, by intradermal injection, approximately 6 months apart. Participants will be followed by a combination of visits and telephone contacts through Study Day 264. Participants will undergo TST testing 3 months after the second BCG vaccination and QuantiFERON TB Gold in-Tube (QTBGT), or the equivalent, if necessary. Two BCG vaccinations given 6 months apart were chosen for this study to give optimal T cell and antibody responses for future study. Leukapheresis will be conducted prior to the first BCG vaccination and at 56 days after the second BCG vaccination (Hoft, 2002; Brown, 2003; de Valliere, 2005). The final leukapheresis timing was selected based on results from functional biological assays, which suggest analysis of samples at this time point may provide insight into the protective immune responses elicited by BCG, and on results of prior clinical trials describing the peak immune responses to BCG (Hoft, 2002; Brown, 2003; de Valliere, 2005). The study will be conducted at a single site in the US (Saint Louis University \[SLU\]).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	bacillus Calmette-Guérin	BCG injection for prevention of tuberculosis

Timeline

• Start date: 2017-08-08
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2017-06-05
• Last updated: 2019-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study