Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines
Summary
This is a Multi-Part, Phase 3, randomized, observer-blinded study to evaluate the safety and immunogenicity of booster doses of Omicron subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines (SARS-CoV-2 rS) adjuvanted with Matrix-M™ adjuvant (NVX-CoV2515 \[BA.1\] and NVX-CoV2540 \[BA.5\]) and bivalent (NVX-CoV2373 \[prototype\] + Omicron subvariant) SARS-CoV-2 rS vaccines (NVX-CoV2373 + NVX CoV2515 and NVX CoV2373 + NVX CoV2540) in previously vaccinated adults 18 years of age and older.
Timeline
- Start
- 2022-05-25
- Primary completion
- 2022-07-17
- Completion
- 2024-04-07
Outcome
Met primary endpoint
paper All three coprimary endpoints were met in part 2 of the ongoing 2019nCoV-311 study. PMID 38460525 ↗
release “Announced topline results from Phase 3 COVID-19 Omicron BA.1 vaccine candidate, achieving the primary strain-change endpoint” novavax.com ↗
release “Phase 3 Boosting Trial for the SARS-CoV-2 rS Variant Vaccines (COVID-19) showing that the Company's BA.1 vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint.” novavax.com ↗
Publications
- Bennett C, Rivers EJ, Woo W, Bloch M, Cheung K, Griffin P, Mohan R, Deshmukh S, Arya M, Cumming O, Neville AM, Pardey TM, Plested JS, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Buchanan A, Marcheschi A, Swan J, Smith G, Cho I, Glenn GM, Walker R, Mallory RM. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial. J Infect Dis. 2024 Jul 25;230(1):e4-e16. doi: 10.1093/infdis/jiad508.
- Bennett C, Woo W, Bloch M, Cheung K, Griffin P, Mohan R, Deshmukh S, Arya M, Cumming O, Neville AM, McCallum Pardey TG, Plested JS, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Marcheschi A, Swan J, Smith G, Cho I, Glenn GM, Walker R, Mallory RM; Novavax 2019nCoV-311 Study Group. Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial. Lancet Infect Dis. 2024 Jun;24(6):581-593. doi: 10.1016/S1473-3099(24)00077-X. Epub 2024 Mar 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NVX-CoV2373 | Vaccine | 0.5 ml | Intramuscular |
| Subject | NVX-CoV2373 + NVX-CoV2515 | Unknown | 5 ug | Intramuscular |
| Subject | NVX-CoV2373 + NVX-CoV2515 | Unknown | 50 ug | Intramuscular |
| Subject | NVX-CoV2373 + NVX-CoV2540 | Unknown | 5 ug | Intramuscular |
| Subject | NVX-CoV2373 + NVX-CoV2540 | Unknown | 50 ug | Intramuscular |
| Subject | NVX-CoV2515 | Vaccine | 0.5 ml | Intramuscular |
| Subject | NVX-CoV2540 | Vaccine | 0.5 ml | Intramuscular |