Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NVX-CoV2373 · 5 trials · 3 indications
Comparative IgG antibody responses on Day 14, summarized in terms of the ratio of IgG GMTs and difference in seroconversion rates (SCR; defined as ≥ 4-fold increase from baseline booster dose) between the vaccines. Non-inferiority will be demonstrated if: * The lower bound of the two-sided 95% CI on the ratio of the GMTS (GMTNVX-CoV2373/GMTBBIBP-CorV) is ≥ 0.6667, AND * The lower bound of the two-sided 95% CI on the difference between the SCRs (SCRNVX-CoV2373 - SCR BBIBP-CorV) is ≥ 10%.
All safety analyses will be summarized descriptively by vaccine group using the Safety Analysis Set. To compare the overall safety, the two-sided 95% CIs for the difference of incidence of solicited AEs for 7 days following each vaccination. Recording of solicited and unsolicited AEs may be conducted by electronic data capture (EDC)/reporting. All AEs will be followed until resolution or until clinically stable.
All safety analyses will be summarized descriptively by vaccine group using the Safety Analysis Set. 1085BUnsolicited AEs will be coded by preferred term and system organ class using MedDRA and summarized by vaccine group as well as by severity and relationship to booster vaccine. Unsolicited AEs through 28 days after the booster vaccination. Recording of solicited and unsolicited AEs may be conducted by electronic data capture (EDC)/reporting. All AEs will be followed until resolution or until clinically stable.
To compare the overall safety of a single booster injection of NVX-CoV2373 with Matrix-M adjuvant with a single booster injection of BBIBP-CorV in participants previously vaccinated with a primary two-dose series of the BBIBP-CorV vaccine. Recording of solicited and unsolicited AEs may be conducted by electronic data capture (EDC)/reporting. All AEs will be followed until resolution or until clinically stable.
Neutralizing Antibody responses to ancestral strain Novavax vaccine (NVX-CoV2373) for the participants in the ancestral strain NVX-2373 group and NVX-CoV2540 group at Day 29
Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.
Neutralizing antibody To determine if the combination of antigen and adjuvant levels of NVX-CoV2601 GMTR against the Omicron subvariant XBB.1.5 superior(LB of the 95% CI for GMTR \> 1.0) to that elicited by NVX-CoV2373
Neutralizing antibody SRR against the Omicron XBB.1.5 subvariant elicited by NVXCoV2601 is non-inferior (NI)to the SRR elicited by NVX-CoV2373in participants ≥ 50 years of age previously vaccinated with ≥ 3 doses of a COVID-19 prototype or bivalent licensed mRNA vaccine.
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Number of HIV-Negative participants with unsolicited AEs.
Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.
Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.
Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.
Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.
Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.
Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.
Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.
Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.
Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.
| Arm | Type | Description |
|---|---|---|
| NVX-CoV2373 | EXPERIMENTAL | NVX-CoV2373 (5 μg): Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg antigen and 100 μg adjuvant per mL. The vaccination regimen will comprise of 1 intramuscular (IM) injection on Day 0 of 0.5 mL injection volume at a dose of 5 μg of antigen with 50 μg Matrix-M adjuvant. |
| BBIBP CorV | ACTIVE_COMPARATOR | Sinopharm BBIBP-CorV vaccine administered per manufacturer instructions as a single intramuscular injection. |
| NVX CoV2373 (Ancestral strain) | EXPERIMENTAL | 1dose of NVX-COV2373 on Day 1 |
| Updated COVID-19 Vaccine | EXPERIMENTAL | 1dose of updated COVID-19 vaccine on Day 1 |
| Lot 1 | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. |
| Lot 2 | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. |
| Lot 3 | EXPERIMENTAL | 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1. |
| Group-A Monovalent NVX-CoV2373 (5 μg) | EXPERIMENTAL | The Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant |
| Group-B Monovalent NVX-CoV2601 (5 μg) | EXPERIMENTAL | Monovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant) |
| Group-C Monovalent NVX-CoV2601 (5 μg) | EXPERIMENTAL | Monovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant) |
| Group-D Monovalent NVX-CoV2601 (35 μg) | EXPERIMENTAL | Monovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant) |
| Group-E Monovalent NVX-CoV2601(35) | EXPERIMENTAL | Monovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant) |
| Group-F Monovalent NVX-CoV2601 (50 μg) | EXPERIMENTAL | Monovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant) |
| Group-G Bivalent XBB.1.5 | EXPERIMENTAL | Bivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine |
| Group 1 PLWH | EXPERIMENTAL | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. |
| Group 2 PLWH | EXPERIMENTAL | Three doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0, Day 21, and Day 70. |
| Group 3 PLWH | EXPERIMENTAL | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. |
| Group 4 HIV-Negative Participants | EXPERIMENTAL | 2 doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70. |
| Group 5 HIV-Negative Participants | EXPERIMENTAL | Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21. |
| Name | Type | Description |
|---|---|---|
| NVX-CoV2373 | BIOLOGICAL | A single booster injection of NVX-CoV2373 with Matrix-M adjuvant. 0.5 mL injection volume at a dose of 5μg of antigen with 50 μg Matrix-M adjuvant |
| BBIBP-CorV vaccine | BIOLOGICAL | BBIBP-CorV vaccine administered per manufacturer instructions. |
| SARS-CoV-2 rS antigen/Matrix-M Adjuvant | BIOLOGICAL | 1 intramuscular (IM) injection of 5 µg SARS-CoV-2 rS antigen+ 50 µg Matrix-M1 adjuvant (0.5 mL) given on Day 1 |
| NVX-CoV2373 (5μg) | BIOLOGICAL | Coformulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant: supplied as a solution for preparation for injection, at a concentration of 10 μg/mL and 100 μg adjuvant per mL, respectively |
| NVX-CoV2601 (5μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 50 µg Matrix-M adjuvant. |
| NVX-CoV2601(5μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 5 µg of antigen with 75 µg Matrix-M adjuvant. |
| NVX-CoV2601 (35μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 50 µg Matrix-M adjuvant. |
| NVX-CoV2601(35μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 35 µg of antigen with 75 µg Matrix-M adjuvant. |
| NVX-CoV2601(50μg) | BIOLOGICAL | The vaccination regimen will comprise one IM injection on Day 0 at a dose of 50 µg of antigen with 100 µg Matrix-M adjuvant |
| Bivalent BA.4/5 | BIOLOGICAL | The bivalent BA.4/5 (or recommended mRNA vaccine at the time of the conduct of this study) Omicron subvariant/prototype licensed mRNA vaccine will be procured and stored per the manufacturer's instructions. For this vaccine group, treatment will be administered open label as a single IM injection |
Inclusion Criteria: 1. Adults ≥ 18 years of age, inclusive, at screening. 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. Females of childbearing potential (defined as any female who has experienced menarche) who is NOT surgically steri...
NVX-CoV2373 is a vaccine being studied for the prevention of COVID-19, including SARS-CoV-2 infection and severe acute respiratory syndrome coronavirus 2. It is intended for use in adults, including those living with HIV and healthy volunteers, as a primary or booster vaccination.
NVX-CoV2373 is a recombinant protein vaccine that targets the SARS-CoV-2 spike protein. It is designed to elicit an immune response against the virus that causes COVID-19, potentially providing protection against infection and severe disease.
NVX-CoV2373 is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The company has conducted multiple clinical trials to evaluate the vaccine's safety and immunogenicity.
NVX-CoV2373 is in Phase 3 clinical development. It has completed Phase 3 trials, including a boosting study and a study of the vaccine as a booster after mRNA vaccines. It remains investigational and is not yet approved for public use.
NVX-CoV2373 has been studied in several completed trials, including NCT05112848 in people living with HIV, NCT05249816 as a Phase 3 booster, NCT05875701 as a booster after mRNA vaccines, and NCT05925127 as a heterologous booster with different dose levels.
NVX-CoV2373 is a COVID-19 vaccine candidate developed by Novavax. It is designed to prevent COVID-19 and has been evaluated in clinical trials for safety and immunogenicity. It is not the same as other COVID-19 vaccines, as it uses a protein-based technology.