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

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Non-Tuberculous Mycobacteria; Bronchiectasis Adult; Cystic Fibrosis

Treatments: Biological: BCG TICE Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT04884308

IRB00256425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Cystic Fibrosis

Experimental group

Description:

Participants with Cystic Fibrosis.

Treatment:

Biological: BCG TICE Vaccine

Non Cystic Fibrosis Bronchiectasis

Experimental group

Description:

Participants with Non Cystic Fibrosis Bronchiectasis.

Treatment:

Biological: BCG TICE Vaccine

Healthy Volunteer

Active Comparator group

Description:

Participants with no condition (healthy volunteers).

Treatment:

Biological: BCG TICE Vaccine