drugset / Trial / NCT05370040
THEMBA II T-Cell Vaccine: Vaccination With saRNA COVID-19 Vaccines
RandomizedSequentialTriple-blindTreatment
Summary
This is a phase 1/2 open-label study assessing the safety, reactogenicity, and immunogenicity of saRNA COVID-19 boost vaccines in participants that have been previously vaccinated against or previously infected with COVID-19.
Timeline
- Start
- 2022-05-05
- Primary completion
- 2024-03-11
- Completion
- 2024-03-11
Outcome
Outcome not reported
Stopped (Enrollment): “Discontinued prior to enroll in Phase 2”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AAHI-SC2 | Small activating RNA (saRNA) | 25 ug | Intramuscular |
| Subject | AAHI-SC2 | Small activating RNA (saRNA) | 50 ug | Intramuscular |
| Subject | AAHI-SC2 | Small activating RNA (saRNA) | 70 ug | Intramuscular |
| Subject | AAHI-SC3 | Small activating RNA (saRNA) | 25 ug | Intramuscular |
| Subject | AAHI-SC3 | Small activating RNA (saRNA) | 50 ug | Intramuscular |
| Subject | AAHI-SC3 | Small activating RNA (saRNA) | 85 ug | Intramuscular |