drugset / Trial / NCT05925127
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
RandomizedCrossoverDouble-blindPrevention
Summary
This is a Phase 2/3, randomized, double-blind study to evaluate the safety and immunogenicity of different booster dose levels of the monovalent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle (SARS-CoV-2 rS) vaccines with Matrix-M™ adjuvant (NVX-CoV2373 \[prototype Wuhan vaccine with Matrix-M adjuvant\] or NVX-CoV2601 \[Omicron XBB.1.5 subvariant vaccine with Matrix-M adjuvant\]).
Timeline
- Start
- 2023-10-16
- Primary completion
- 2024-05-21
- Completion
- 2024-05-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bivalent BA.4/5 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | MIVALSECOVATEIN | Vaccine | 5 ug | Intramuscular |
| Subject | MIVALSECOVATEIN | Vaccine | 35 ug | Intramuscular |
| Subject | MIVALSECOVATEIN | Vaccine | 50 ug | Intramuscular |
| Subject | NVX-CoV2373 | Vaccine | 5 ug | — |