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Vaccine
BCG Vaccine + TB Drugs for Tuberculosis
Phase 1
Waitlist Available
Led By James Kublin, MD, MPH
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
Study Summary
This trial will assess the effectiveness of TB drugs and vaccines to fight mycobacterial infection in humans. It will also test new, innovative study designs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BCG Vaccine
Secondary outcome measures
Antibodies, Bacterial
Quantification of IgA in the blood after BCG immunization and INH or RIF dosing.
Quantification of IgG in the blood after BCG immunization and INH or RIF dosing.
+1 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: BCG Challenged-RIF TreatedActive Control2 Interventions
Will receive RIF in the dose of 600 mg for seven days post BCG injection.
Group II: BCG Challenged-Isoniazid TreatedActive Control2 Interventions
Will receive INH in the dose of 300 mg for three days post BCG injection.
Group III: BCG Challenged-Isoniazid UntreatedPlacebo Group1 Intervention
Will not receive any INH or RIF dose.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,533 Total Patients Enrolled
8 Trials studying Tuberculosis
3,154 Patients Enrolled for Tuberculosis
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,248 Total Patients Enrolled
2 Trials studying Tuberculosis
2,957 Patients Enrolled for Tuberculosis
James Kublin, MD, MPHPrincipal InvestigatorFred Hutchinson Cancer Center
2 Previous Clinical Trials
1,051 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested negative for HIV-1.You have a past record of seizures, except those caused by a fever during childhood.You have received immunotherapy within the past year before receiving Tice® BCG treatment.You cannot get any killed or inactivated vaccines 2 weeks before or after receiving Tice® BCG.You currently have any type of cancer that is actively growing.You do not have hepatitis B or hepatitis C.You have received or plan to receive a weakened live vaccine within 4 weeks of getting the Tice® BCG treatment.You have a past medical history of a disorder that causes bleeding.If you have experienced any of the following symptoms within 72 hours before receiving Tice® BCG treatment - fever, chills, malaise, fatigue, headache, night sweats, weight loss, nausea, vomiting, bleeding, diarrhea, abdominal pain, runny nose, cough, wheezing, or difficulty breathing - or if you have swollen lymph nodes, enlarged liver or spleen, or lung disease on the day of the treatment, you will not be eligible for the clinical trial.You live with or work closely with someone who has a weakened immune system due to certain medical conditions, age or pregnancy.You tested negative for tuberculosis using the QuantiFERON-TB Gold test.Your blood test results show a very low response to the tuberculosis (TB) antigen, and the response to the TB antigen is less than 25% of the response to a non-specific antigen. However, your response to the mitogen antigen is relatively high.The protein level in your urine should be less than 1, according to a urine dipstick test.You need to give your written agreement before the study can begin.Women who can become pregnant and are sexually active with men must use a reliable form of birth control from 30 days before until 3 months after receiving Tice® BCG. If you have had permanent sterilization procedures like tubal ligation, bilateral oophorectomy, or hysterectomy, or have had a successful device placement with radiological confirmation test at least 90 days after the procedure, you do not need to use contraception. Acceptable birth control methods include sexual abstinence, using condoms, diaphragms with spermicide or foam, intrauterine devices, NuvaRing®, and hormonal methods such as implants, injectables or oral contraceptives ("the pill").If you are a woman who could become pregnant, you will need to take a pregnancy test before enrolling in the study and again just before receiving the Tice® BCG treatment.You have struggled with alcohol or drug addiction within the past 5 years.You have a body mass index (BMI) greater than 35.You are in overall good health according to a physical exam, medical history, and basic vital sign measurements like temperature, pulse, and blood pressure.You are a man or a woman who is not pregnant and between the ages of 18 and 45.You have a pacemaker, prosthetic valve, or any other implanted heart device.You cannot have taken or plan to take any experimental drugs, vaccines, biologics, or devices within 30 days before or 90 days after receiving Tice® BCG.Your heart beats too slowly (less than 50 beats per minute) or too fast (more than 100 beats per minute).
Research Study Groups:
This trial has the following groups:- Group 1: BCG Challenged-RIF Treated
- Group 2: BCG Challenged-Isoniazid Treated
- Group 3: BCG Challenged-Isoniazid Untreated
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the BCG Challenged-Isoniazid Treated regimen been given regulatory acceptance?
"The safety rating assigned to BCG Challenged-Isoniazid Treated was 1, as this is a Phase 1 trial and the available data supporting efficacy and safety are limited."
Answered by AI
Who is eligible to partake in this clinical investigation?
"Eligibility to this trial is dependent on having an active tuberculosis diagnosis and being between 18-45 years old. Currently, there are 10 spots available for interested patients."
Answered by AI
How many volunteers are taking part in this experiment?
"Affirmative. According to data from clinicaltrials.gov, this medical trial is actively seeking out participants with the study first being posted on October 7th 2022 and updated as recently as October 19th 2022. The team needs 10 patients at 1 research centre."
Answered by AI
Has recruitment for this trial commenced?
"According to its page on clinicaltrials.gov, this investigation has been active since October 7th 2022 and is currently seeking volunteers. The trial was last amended on the 19th of October 2022."
Answered by AI
Is this research program open to participants who are forty or older?
"Patients aged between 18 to 45 are eligible for this medical trial. Separately, 50 studies exist that cater exclusively to minors and 137 trials focus on patients over 65 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Washington
How old are they?
18 - 65
What site did they apply to?
Fred Hutchinson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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