Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
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Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Prevention
Enrollment
497actual
Sites
8
Countries
Mozambique, South Africa
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 | 2023-07-31 | actual | When the study began enrolling |
| Primary completion | 2026-03-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-18 | 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 & 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 each dose up to 28 days after each dose
Proportion of participants with at least one unsolicited AE occurring from Dose 1 to 28 days post-Dose 3
measured From Dose 1 up to 28 days post-Dose 3
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
measured From Dose 1 up to 168 days post-Dose 3
Number of unsolicited AEs from Dose 1 to 28 days post-Dose 3
measured From Dose 1 up to 28 days post-Dose 3
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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