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Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US

NCT02413502 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-10-09

No results posted yet for this study

Summary

The objective of this protocol is to obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after one dose of BCG in BCG-naïve healthy adults.

Conditions

Interventions

BIOLOGICAL

BCG

BCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10\^8 CFUs.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Aeras

    lead OTHER

Principal Investigators

  • Ann M. Ginsberg, MD, PhD · Aeras

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-09-30
Completion
2015-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02413502 on ClinicalTrials.gov