A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
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Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
163actual
Sites
5
Country
United States
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 | 2023-11-13 | actual | When the study began enrolling |
| Primary completion | 2025-05-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-03-20 | actual | The whole study's end, after follow-up |
| First posted | 2023-10-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Malaria
Interventions
- Biological: BNT165e
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFFrequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded 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/joint pain, and fever) recorded up to 7 d after each dose
measured Up to 7 days after each dose
Frequency of participants with at least one adverse event occurring until 28 days after each dose
measured Up to 28 days after each dose
Frequency of participants with at least one medically attended adverse event occurring until 24 weeks after last received IMP dose
measured Up to 24 weeks after last received IMP dose
Frequency of participants in each cohort with at least one serious adverse event occurring until 24 weeks after last received IMP dose
measured Up to 24 weeks after last received IMP dose
Publications
- PMID 40245769 — 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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