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

NCT ID: NCT04884308

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2023-12-30

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.

Conditions

Cystic Fibrosis; Bronchiectasis Adult; Non-Tuberculous Mycobacteria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cystic Fibrosis

Participants with Cystic Fibrosis.

Group Type: EXPERIMENTAL

BCG TICE Vaccine

Intervention Type: BIOLOGICAL

Intradermal vaccination with BCG TICE

Non Cystic Fibrosis Bronchiectasis

Participants with Non Cystic Fibrosis Bronchiectasis.

Group Type: EXPERIMENTAL

BCG TICE Vaccine

Intervention Type: BIOLOGICAL

Intradermal vaccination with BCG TICE

Healthy Volunteer

Participants with no condition (healthy volunteers).

Group Type: ACTIVE_COMPARATOR

BCG TICE Vaccine

Intervention Type: BIOLOGICAL

Intradermal vaccination with BCG TICE

Interventions

BCG TICE Vaccine

Intradermal vaccination with BCG TICE

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noah Lecthzin, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00256425

Identifier Type: -

Identifier Source: org_study_id