A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
← catalyst calendarNCT07698600 · readout ≤ 530 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
126estimated
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 | Jul 2026 | estimated | When the study began enrolling |
| Primary completion | Jan 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV -1 Infection
Interventions
- Biological: BNT168
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFOccurrence of at least one adverse event
measured From dosing through 28 days after each IMP dose
Occurrence of at least one serious adverse event
measured From Dose 1 through the end of study (up to 12 months)
Occurrence of at least one adverse event of special interest
measured From Dose 1 through the end of study (up to 12 months)
Occurrence of at least one solicited local reaction (pain, erythema/redness, swelling) at the IMP injection site
measured Up to 7 days after each IMP dose
Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/tiredness, myalgia/muscle pain, fever)
measured Up to 7 days after each IMP dose
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