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Cancer Vaccine

BCG Vaccine for Cystic Fibrosis

Phase 2
Waitlist Available
Led By Keira Cohen, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is testing whether or not the BCG vaccine can help adults with cystic fibrosis or non-cystic fibrosis bronchiectasis by boosting their immunity.

Who is the study for?
Adults with cystic fibrosis or non-CF bronchiectasis can join this trial if they have a lung function (FEV1) over 40% and can commit to the study duration. They must not have had TB, NTM infections, prior BCG vaccination, recent vaccines, severe vaccine allergies, immunosuppression conditions like HIV, recent use of strong immune system drugs, liver issues like cirrhosis, be pregnant/breastfeeding or participating in another study.Check my eligibility
What is being tested?
The trial is testing the effects of the BCG TICE Vaccine given through the skin on adults with cystic fibrosis and non-CF bronchiectasis compared to healthy volunteers. It aims to understand how well it boosts their immune systems against infections.See study design
What are the potential side effects?
Possible side effects from the BCG vaccine may include redness or soreness at injection site, mild fever and flu-like symptoms. Rarely more serious reactions such as an abscess at injection site or swollen glands could occur.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BCG Uptake

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Non Cystic Fibrosis BronchiectasisExperimental Treatment1 Intervention
Participants with Non Cystic Fibrosis Bronchiectasis.
Group II: Cystic FibrosisExperimental Treatment1 Intervention
Participants with Cystic Fibrosis.
Group III: Healthy VolunteerActive Control1 Intervention
Participants with no condition (healthy volunteers).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BCG TICE Vaccine
2021
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,751 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
7,165 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
189 Previous Clinical Trials
37,181 Total Patients Enrolled
182 Trials studying Cystic Fibrosis
34,244 Patients Enrolled for Cystic Fibrosis
Keira Cohen, MDPrincipal InvestigatorJohns Hopkins University

Media Library

BCG TICE Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04884308 — Phase 2
Cystic Fibrosis Research Study Groups: Cystic Fibrosis, Non Cystic Fibrosis Bronchiectasis, Healthy Volunteer
Cystic Fibrosis Clinical Trial 2023: BCG TICE Vaccine Highlights & Side Effects. Trial Name: NCT04884308 — Phase 2
BCG TICE Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04884308 — Phase 2
Cystic Fibrosis Patient Testimony for trial: Trial Name: NCT04884308 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what condition is the BCG TICE Vaccine typically employed?

"BCG TICE Vaccine can be used to address the presence of tuberculosis, urothelial carcinoma recurrently, and high-grade intraepithelial neoplasia in the bladder."

Answered by AI

How many participants have been recruited for this experiment?

"Affirmative, clinicaltrials.gov indicates that this medical trial is currently recruiting participants. This study was initially posted on April 28th 2021 and recently updated on January 26th 2022. A total of 180 patients are sought from 2 distinct sites."

Answered by AI

Are there any opportunities for enrollment in this experiment currently?

"At this time, the information posted on clinicaltrials.gov shows that recruitment for this medical trial is in effect. This study was first announced at the end of April 2021 and has been revised as recently as January 2022."

Answered by AI

Does this investigation accept participants of an advanced age?

"This medical trial requires participants to be in the 18-65 age range. There are 99 clinical trials available for minors and 427 studies dedicated to those over 65 years old."

Answered by AI

What potential risks are associated with the BCG TICE Vaccine?

"Although there are no efficacy studies available, our team at Power have rated the safety of BCG TICE Vaccine as a 2 due to preliminary Phase 2 data supporting its use."

Answered by AI

Are there any prior research endeavors that employed the BCG TICE Vaccine?

"As of now, there are 21 trials related to the BCG TICE Vaccine taking place, with 7 in their final Phase 3. Nashville, Tennessee is at the epicentre for this research; however 60 other locations have initiated clinical trials involving BCG TICE Vaccine."

Answered by AI

Is this an unprecedented research endeavor?

"Currently, 21 distinct experiments with BCG TICE Vaccine are running in 14 countries and 26 cities. The first such trial began in 2007 under Kael-GemVax Co., Ltd's auspices and recruited 54 participants for its Phase 2 drug approval. Subsequent to the inaugural research endeavor, a further 51 investigations have been conducted on this topic."

Answered by AI

Do I fulfill the prerequisites for enrollment in this medical trial?

"This medical study seeks 180 cystic fibrosis patients aged 18-65. All willing participants must meet the following conditions: Acknowledgement of the protocol and its components, Diagnosis of either CF or non-CF bronchiectasis, FEV1 greater than 40%, Ability to attend all follow up appointments, HIV negative test results at screening, Agreement to participate with written informed consent."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What site did they apply to?
Johns Hopkins
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I try antibiotics that you inhale but couldn’t do it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
2021. "Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04884308.
~7 spots leftby Apr 2025
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