Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against… (NCT05547464) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
Mozambique, South Africa497 participantsStarted 2023-07-31
Plain-language summary
This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule.
This study includes: Part A (Phase Ib) and Part B (Phase IIa).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Cardiovascular diseases, e.g., myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmias, myocarditis, or pericarditis.
. Hypertension
. Diabetes mellitus type 1 or type 2 cases requiring medication.
. Thyroidectomy, or thyroid disease requiring medication during the last 12 months.
. Malignancy within 5 years of Visit 0, excluding localized basal or squamous cell cancer.
. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), or (in Part B only) are on a medication determined by the investigator to increase the risk of bleeding.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each dose
Timeframe: Up to 7 days after each dose
2
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle pain & joint pain, chills, and fever) up to 7 days after each dose
Timeframe: Up to 7 days after each dose
3
Proportion of participants with at least one adverse event (AE) occurring from each dose to 28 days after each dose
Timeframe: From each dose up to 28 days after each dose
4
Proportion of participants with at least one unsolicited AE occurring from Dose 1 to 28 days post-Dose 3
Timeframe: From Dose 1 up to 28 days post-Dose 3
5
Proportion of participants with at least one serious AE or AE of special interest occurring from Dose 1 up to 168 days post-Dose 3
Timeframe: From Dose 1 up to 168 days post-Dose 3
6
Number of unsolicited AEs from Dose 1 to 28 days post-Dose 3
. Seizure disorder: History of seizure(s) within past 3 years. Also exclude if participant has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
. An abnormal screening or Visit 1 ECG (i.e., showing the corrected QT interval by Fridericia (QTcF) \>450 ms; significant ST-T wave changes suggestive of myocardial ischemia or of an acute or indeterminate-age myocardial infarction; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions; complete right or left bundle branch block \[QRS \>120 ms\]; second- or third-degree atrioventricular block); or other clinically significant abnormalities on the ECG at the investigator's discretion.