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BCG Vaccine for Tuberculosis Prevention (TIPI Trial)
TIPI Trial Summary
This trial is investigating whether the BCG vaccine can help prevent tuberculosis infection in adults travelling to countries with high rates of TB.
TIPI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTIPI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TIPI Trial Design
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Who is running the clinical trial?
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- I have had radiation or chemotherapy in the past 6 months.I am currently on treatments that weaken my immune system.I have had 2 or more live vaccines in the last 30 days before getting the BCG/placebo vaccine.You have a known or suspected allergy to the BCG vaccine or similar products.I am in good health as confirmed by recent medical exams.I was likely exposed to TB from someone infectious 8-10 weeks ago.I am between 18 and 65 years old.I agree not to have any TB skin tests for 6 months after getting the BCG/placebo vaccine.I have never had a tuberculosis infection.I am willing to wait 7 days after my COVID-19 vaccine before getting the BCG/placebo vaccine.I got a COVID-19 vaccine less than a week before the BCG/placebo vaccine.I am willing and able to attend all study visits and can be contacted by phone or email.You have experienced a very serious reaction after getting a vaccine in the past.I have been using oral steroids for over a month or had IV steroids in the last 3 months.I have received BCG treatment for my bladder cancer.I cannot receive the BCG vaccine due to a condition like HIV.I have had a nontuberculous mycobacterial infection before.I am currently pregnant, planning to become pregnant soon, or am breastfeeding.I have never received a BCG vaccine or been part of a tuberculosis vaccine trial.I plan to travel or work in a high TB risk area for a specific time.
- Group 1: BCG vaccine
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are geriatric patients being accepted into the trial?
"In order to take part in this trial, potential patients must meet the age requirement of being between 18-65. Out of the 1,036 total clinical trials, this age group represents 261 of them."
Are there any patients needed for this experiment currently?
"Correct, according to the clinicaltrials.gov website, this study is still recruiting patients. This trial was first posted on December 1st, 2021 and was most recently updated on September 2nd, 2022. They are looking for a total of 2000 participants from 7 different locations."
Does this research build off of other similar investigations?
"Kael-GemVax Co., Ltd. conducted the first study on BCG (Tokyo 172) vaccine in 2007 with 54 participants. The success of this initial study allowed the vaccine to move onto Phase 2 clinical trials and receive drug approval. There are currently 22 active studies involving BCG (Tokyo 172) taking place in 27 cities and 14 countries."
How is BCG (Tokyo 172) vaccine most often used?
"BCG (Tokyo 172) vaccine can help patients suffering from tuberculosis (tb), urothelial carcinoma recurrent, and carcinoma in situ of urinary bladder."
Is the BCG (Tokyo 172) vaccine unique in its clinical trial history?
"BCG (Tokyo 172) was first studied in 2007 at Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office. With a total of 18282 completed trials, this vaccine is currently being trialed in 22 different locations, most of which are based in New Haven, Connecticut."
Could you please provide data regarding the safety of BCG (Tokyo 172) vaccine?
"There is existing efficacy and safety data for BCG (Tokyo 172) vaccine, so it was given a score of 3."
Are the trial sites for this investigation geographically dispersed?
"In addition to Yale University and Baylor College of Medicine, this study is also being conducted out of JBR Clinical Research and 7 other locations."
Could you please provide an estimate for the total trial enrolment?
"That is correct. The clinical trial in question, which was initially posted on December 1st, 2021, is still recruiting patients as of September 2nd, 2022. The trial has a total goal of 2000 participants, which it hopes to enroll at 7 different sites."
Could I possibly be a candidate for this clinical experiment?
"This study is looking for 2000 patients, between the ages of 18 and 65, who currently have tuberculosis. Additionally, it is important that participants meet the following criteria: They are willing to participate in the study and provide informed consent, They are willing to complete all required study visits, They are male or female and of age, They are in good general health, They have no known history of Mtb infection, They have no prior history of BCG vaccination or previous receipt of an investigational Mtb vaccine, They are assessed to be at risk for TB exposure during planned travel, They are willing to forego any periodic tubercul"
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