Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVX-CoV2515 · 1 trial · 2 indications
Microneutralization \[MN\] geometric mean titers (GMTs) with an inhibitory concentration of 50% (MN50) to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
Seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline \[Day 0\]) in MN50 titer concentrations to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
Neutralizing antibody (NAb) GMTs to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination.
SRRs in NAb titer concentrations to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination
NAb GMTs to the ancestral (Wuhan) strain, assessed at Day 28 following initial study vaccination.
| Arm | Type | Description |
|---|---|---|
| Group A (NVX-CoV2515 ) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0. |
| Group B (NVX-CoV2373 ) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0. |
| Group C (NVX-CoV2515 ) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0. |
| Group D (NVX-CoV2373) | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0. |
| Group E (BA.1 Bivalent Vaccine) | EXPERIMENTAL | 1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0. |
| Group F (NVX-CoV2540) | EXPERIMENTAL | 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90. |
| Group G (NVX-CoV2373) | EXPERIMENTAL | 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90. |
| Group H (NVX-CoV2373 + NVX-CoV2540) | EXPERIMENTAL | 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90. |
| Name | Type | Description |
|---|---|---|
| NVX-CoV2515 | DRUG | Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL). |
| NVX-Cov2373 | DRUG | Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). |
| NVX-CoV2373 + NVX-CoV2515 | DRUG | Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant. |
| NVX-CoV2540 | DRUG | Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). |
| NVX-CoV2373 + NVX-CoV2540 | DRUG | Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant. |
Part 1 Inclusion Criteria: To be included in this study, each individual must satisfy all the following criteria: 1. Adults ≥ 18 and ≤ 64 years of age at screening. 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. Female participants o...
NVX-CoV2515 is an investigational vaccine being studied for COVID-19, specifically for use as a booster against SARS-CoV-2 infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
NVX-CoV2515 is being developed by Novavax, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol NVAX. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
NVX-CoV2515 is in Phase 3 clinical development. A Phase 3 boosting study has been completed, evaluating the vaccine as a booster against SARS-CoV-2 variants. The vaccine remains investigational and is not yet approved for public use.
NVX-CoV2515 has been studied in a Phase 3 clinical trial registered as NCT05372588, titled 'Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines.' This completed trial enrolled 1,340 participants aged 18 years and older in Australia.
Yes, NVX-CoV2515 is classified as a small molecule modality. It is being developed as a vaccine candidate for COVID-19, with the completed Phase 3 trial focusing on its use as a booster against SARS-CoV-2 infection.