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Brief Title: Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections

Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers

INTRODUCTION

  • Org Study ID: IRB00256425
  • Secondary ID: N/A
  • NCT ID: NCT04884308
  • Sponsor: Johns Hopkins University

BRIEF SUMMARY

This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.

DETAILED DESCRIPTION

This single-site, open-label clinical trial to investigate the immune effects of BCG vaccination in adults with cystic fibrosis, non-cystic fibrosis bronchiectasis and healthy volunteers by measuring pre and post vaccination immune responses, BCG uptake and protection against infections, including nontuberculous mycobacteria (NTM). This study will also gather data on study feasibility, tolerability, and safety.

  • Overall Status
    Recruiting
  • Start Date
    April 28, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Cystic Fibrosis
  • Bronchiectasis Adult
  • Non-Tuberculous Mycobacteria

ELIGIBILITY

Inclusion Criteria (CF and non-CF bronchiectasis):
* Confirmed diagnosis of either CF or non-CF bronchiectasis

- * Forced expiratory volume over one second (FEV1) > 40%

- * Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.

- * Available for the study duration, including all planned follow-up visits
Inclusion Criteria (Healthy Volunteers):
* Negative HIV enzyme-linked immunosorbent assay (ELISA) and confirmatory test at screening.

- * Willingness to participate in the study after all aspects of the protocol have been explained and written informed obtained.

- * Available for the study duration, including all planned follow-up visits
Exclusion Criteria (All arms):
* Current or prior history of active or latent tuberculosis (TB) (per report, not formally tested) or NTM infection

- * Prior BCG vaccination

- * Previous vaccine in the past 4 weeks

- * History of severe anaphylaxis to any vaccine or vaccine components

- * History of organ/bone marrow transplantation or other immunosuppressing condition, including HIV

- * Immunosuppressing drugs (including oral corticosteroids equivalent to >10mg of prednisone for 5 days) in the 30 days prior to study enrollment

- * Cirrhosis or portal hypertension

- * Pregnant or breastfeeding

- * Receipt of another investigational product in the last 28 days or planned receipt during this study

- * Has any other condition that, in the opinion of the principal investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Noah Lecthzin, MD, MHS

Role: Principal Investigator

Affiliation: Johns Hopkins University

Overall Contact

Name: Noah Lecthzin, MD, MHS

Phone: 410-502-7043

Email: nlechtz@jhmi.edu

LOCATION

Facility Status Contact

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