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Also known as XBB.1.5 Vaccine (Booster)
XBB.1.5 Vaccine · 1 trial · 1 indication
Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.
SRRs (proportion of seroconverted participants) in ID 50 titers to the NVXCoV2601 vaccine assessed at Day 28 following the study vaccination.
SRRs (proportion of seroconverted participants) in ID 50 titers to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.
ID 50 GMTs to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.
| Arm | Type | Description |
|---|---|---|
| Group-A XBB.1.5 Vaccine (Booster) | EXPERIMENTAL | The Monovalent \[5 μg/50 μg\] NVX-CoV2601 XBB.1.5 Vaccine (Booster) |
| Group-B The monovalent XBB.1.5 Vaccine (Single Dose). | ACTIVE_COMPARATOR | Group-B The monovalent \[5 μg/50 μg\] NVX-CoV2601 XBB.1.5 Vaccine (Single Dose). |
| Name | Type | Description |
|---|---|---|
| XBB.1.5 Vaccine (Booster) | BIOLOGICAL | Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine (Booster) |
| XBB.1.5 Vaccine (single dose) | BIOLOGICAL | Omicron sub variant XBB.1.5 SARS-CoV-2 rS /Matrix-M Adjuvant the monovalent \[5 μg/50 μg\] NVX-CoV2601) XBB.1.5 Vaccine ( single dose) |
Inclusion Criteria: 1. Adults ≥ 18 years of age at time of study vaccination. 2. Part 1: Previously vaccinated with ≥ 3 doses of the Moderna and/or Pfizer /BioNTech prototype monovalent and/or BA.4/5 containing bivalent COVID-19 vaccines with the last dose administered ≥ 90 days prior to study vacc...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
The XBB.1.5 Vaccine is an investigational COVID-19 booster vaccine developed by Novavax, Inc. It is designed to boost immune response against the Omicron XBB.1.5 subvariant of SARS-CoV-2 in people who have already been vaccinated as well as in unvaccinated individuals.
The XBB.1.5 Vaccine is being studied for use as a COVID-19 booster dose. Its purpose is to evaluate safety and immune response against the Omicron XBB.1.5 subvariant in adults who were previously vaccinated and in those who were not previously vaccinated.
The XBB.1.5 Vaccine is developed by Novavax, Inc., which trades on the Nasdaq under the ticker symbol NVAX. Novavax is the sponsor of the clinical program evaluating this COVID-19 booster candidate.
The XBB.1.5 Vaccine is in Phase 2 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA. The Phase 2 study evaluating it has been completed.
The XBB.1.5 Vaccine was evaluated in one Phase 2 trial, NCT05975060, titled a study to evaluate the safety and immunogenicity of an Omicron subvariant COVID-19 vaccine booster dose. That trial enrolled 660 participants in the United States and is completed.
Yes. The XBB.1.5 Vaccine Booster is another name for the XBB.1.5 Vaccine developed by Novavax. Both names refer to the same investigational COVID-19 booster candidate studied in the Phase 2 trial NCT05975060.