drugset / Trial / NCT05029856
Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).
Timeline
- Start
- 2022-02-04
- Primary completion
- 2022-08
- Completion
- 2022-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SII B.1.351 | Vaccine | 3 ug | Intramuscular |
| Subject | SII B.1.351 | Vaccine | 5 ug | Intramuscular |
| Subject | SII B.1.617.2 | Vaccine | 5 ug | Intramuscular |
| Subject | SII Bivalent | Vaccine | 6 ug | Intramuscular |
| Subject | SII Bivalent | Vaccine | 10 ug | Intramuscular |
| Background | Matrix-M1 | Other / unclassified | 50 ug | Intramuscular |