Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
120actual
Sites
3
Country
Germany
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-04-18 | actual | When the study began enrolling |
| Primary completion | 2025-06-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-08 | actual | The whole study's end, after follow-up |
| First posted | 2022-09-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-22 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Tuberculosis
Interventions
- Biological: BNT164a1
- Biological: BNT164b1
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFFrequency of solicited local reactions (pain, erythema/redness, induration/swelling) at the injection site up to 7 days after each dose
measured Up to 7 days after each dose
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle pain and joint pain, chills, and fever) up to 7 days after each dose
measured Up to 7 days after each dose
Proportion of participants with at least one adverse event (AE) occurring from each dose to 28 days after each dose
measured From Day 1 until Day 197
Proportion of participants with at least one AE occurring from Dose 1 to 28 days post-Dose 3
measured From Day 1 until Day 197
Proportion of participants with at least one serious adverse event (SAE) or medically attended adverse event (MAAE) occurring from Dose 1 up to 168 days post-Dose 3
measured From Day 1 until Day 337
Number of AEs from Dose 1 to 28 days post-Dose 3
measured From Day 1 until Day 197
Publications
- PMID 42286358 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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