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

NCT02413502 | Completed Early Phase 1

• 1 other identifier: A-046
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Immune response measured by Intracellular cytokine staining (ICS)

  ICS used to characterize the response to BCG.

  Day 56 of the study

Study Arms (1)

Bacillus Calmette-Guérin (BCG)

EXPERIMENTAL

Tice brand BCG used to vaccinate BCG-Naïve adults.

Biological: BCG

Interventions

BCG BIOLOGICAL

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

Also known as: TICE BCG

Bacillus Calmette-Guérin (BCG)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has completed the written informed consent process.
• Is age ≥18 years and ≤55 years on Study Day 0.
• Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
• Agrees to avoid elective surgery during the study.
• Willingness to receive HIV test results.
• For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study.
• Has general good health, confirmed by medical history and physical examination.
• Has not received vaccination or immunotherapy with a BCG product at any time prior to Study Day 0.

You may not qualify if:

• Acute illness on Study Day 0.
• HIV-1/2 positive
• Oral temperature ≥37.5°C on Study Day 0.
• Abnormal laboratory values per local laboratory parameters from most recent blood collection prior to Study Day 0 for specific parameters listed in the protocol.
• Evidence of significant active infection.
• Evidence of central nervous system tuberculosis or pleural tuberculosis.
• Screening TST reaction \>5 mm.
• History of treatment for active or latent tuberculosis infection.
• History or evidence of active tuberculosis.
• Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis.
• History of occupational exposure to an individual with active tuberculosis in a health care setting.
• History of autoimmune disease or immunosuppression.
• Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted).
• Received immunoglobulin or blood products within 42 days before Study Day 0.
• Received any investigational drug or investigational vaccine within 182 days before Study Day 0, or planned participation in any other interventional study during the study period.

Sponsors & Collaborators

• Aeras: lead
• University of Rochester: collaborator

MeSH Terms

Conditions

Tuberculosis

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ann M. Ginsberg, MD, PhD

  Aeras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: April 10, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: October 9, 2015

Record last verified: 2015-10