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NVX-CoV2373

Phase 3

COVID-19 | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Apr 17, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials3
Total Enrollment2,052

FDA Designations

No designations recorded

Clinical trial landscape

NVX-CoV2373 · 5 trials · 3 indications

Phase 3 3Phase 2 2
NCT05249816Phase 3 Boosting Study for the SARS-CoV-2 rS VaccineSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
COMPLETED1,000 Analytics
NCT05875701Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA VaccinesCOVID-19
COMPLETED147 Analytics
NCT05463068Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in AdultsCOVID-19
COMPLETED911 Analytics
PHASE3COMPLETED
Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)Unlock trial analytics
PHASE3COMPLETED
Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines
COVID-19Unlock trial analytics
PHASE3COMPLETED
Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
COVID-19Unlock trial analytics

Study Endpoints

Primary Endpoints

Utilizing ratio of IgG GMTs and difference in seroconversion rates to compare IgG antibody responses between the vaccines.
On Day 14.

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%.

Utilizing Case Report Forms and safety follow up via telephone to measure and assess incidence, duration, and severity of solicited local and systemic adverse events (AEs)
For 7 days following each vaccination.

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.

Utilizing Case Report Forms to measure and assess Incidence, duration, severity, and relationship of unsolicited AEs
Through 28 days after the last vaccination.

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.

Utilizing Case Report Forms to measure incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study.
Throughout the study. Note: Beginning on Day 29, only MAAEs related to the vaccine will be recorded.

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 (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Geometric Mean Titers (GMT)
Day 28

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) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs]
Baseline (Day 1) and 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.

Immunogenicity index-Neutralizing antibody expressed as geometric mean titer ratio[GMTR ]against the Omicron subvariant XBB.1.5
Day 28

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

Immunogenicity index-Neutralizing antibody expressed as seroresponse rates (SRRs)against the Omicron subvariant XBB.1.5
Day 28

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 adverse events (AEs)
Day 84

Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

Number of HIV-Negative participants with unsolicited AEs
Day 84

Number of HIV-Negative participants with unsolicited AEs.

Number of PLWH with unsolicited AEs
Day 120

Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

Number of PLWH with solicited systemic AEs
Day 0

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
Day 0

Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

Number of PLWH with solicited local AEs
Day 0

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
Day 0

Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)
Day 21

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 expressed as geometric mean fold rise (GMFR)
Day 21

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 expressed as seroconversion rate (SCR)
Day 21

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.

Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)
Day 21

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.

hACE2 receptor binding inhibition assay expressed as GMFR
Day 21

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.

hACE2 receptor binding inhibition assay expressed as SCR
Day 21

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.

Neutralizing antibody activity expressed as GMT
Day 35

Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.

Neutralizing antibody activity expressed as SCR
Day 35

Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.

Neutralizing antibody activity expressed as GMFR
Day 35

Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.

Secondary Endpoints

Utilizing Plaque Reduction Neutralization Tests (PRNT) to compare neutralizing antibody responses
• PRNT GMTs to the SARS-CoV-2 S protein at Days 0, 14, 28, and 180. • GMFRPost/Pre, defined as the ratio of post-vaccination to pre-vaccination (Day 0) PRNT GMTs within the same treatment arm at Days 14, 28, and 180.
Neutralizing Antibody (Nab) for SARS-CoV-2 Wildtype Virus (Wuhan) Responses Expressed as Seroconversion Rate (SCR)
Day 28
Serum Immunoglobulin G (IgG) ELISA Units to SARS-CoV-2 Spike Protein (Wuhan) Expressed as Geometric Mean ELISA Unit (GMEU)
Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
NVX-CoV2373EXPERIMENTALNVX-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 CorVACTIVE_COMPARATORSinopharm BBIBP-CorV vaccine administered per manufacturer instructions as a single intramuscular injection.
NVX CoV2373 (Ancestral strain)EXPERIMENTAL1dose of NVX-COV2373 on Day 1
Updated COVID-19 VaccineEXPERIMENTAL1dose of updated COVID-19 vaccine on Day 1
Lot 1EXPERIMENTAL1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
Lot 2EXPERIMENTAL1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
Lot 3EXPERIMENTAL1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
Group-A Monovalent NVX-CoV2373 (5 μg)EXPERIMENTALThe Monovalent NVX-CoV2601 of 5 μg of antigen with 50 μg of Matrix-M adjuvant
Group-B Monovalent NVX-CoV2601 (5 μg)EXPERIMENTALMonovalent NVX-CoV2601 (5 μg of antigen with 50 μg of Matrix-M adjuvant)
Group-C Monovalent NVX-CoV2601 (5 μg)EXPERIMENTALMonovalent NVX-CoV2601 (5 μg of antigen with 75 μg of Matrix-M adjuvant)
Group-D Monovalent NVX-CoV2601 (35 μg)EXPERIMENTALMonovalent NVX-CoV2373 (35 μg of antigen with 50 μg of Matrix-M adjuvant)
Group-E Monovalent NVX-CoV2601(35)EXPERIMENTALMonovalent NVX-CoV2601 (35 μg of each antigen with a 75 μg of Matrix-M adjuvant)
Group-F Monovalent NVX-CoV2601 (50 μg)EXPERIMENTALMonovalent NVX-CoV2601 (50 μg of each antigen with a 100 μg of Matrix-M adjuvant)
Group-G Bivalent XBB.1.5EXPERIMENTALBivalent XBB.1.5 Omicron subvariant/prototype COVID-19 licensed mRNA vaccine
Group 1 PLWHEXPERIMENTALTwo 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 PLWHEXPERIMENTALThree doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0, Day 21, and Day 70.
Group 3 PLWHEXPERIMENTALTwo 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 ParticipantsEXPERIMENTAL2 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 ParticipantsEXPERIMENTALTwo 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.

Interventions

NameTypeDescription
NVX-CoV2373BIOLOGICALA 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 vaccineBIOLOGICALBBIBP-CorV vaccine administered per manufacturer instructions.
SARS-CoV-2 rS antigen/Matrix-M AdjuvantBIOLOGICAL1 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)BIOLOGICALCoformulated 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)BIOLOGICALThe 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)BIOLOGICALThe 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)BIOLOGICALThe 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)BIOLOGICALThe 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)BIOLOGICALThe 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.4/5BIOLOGICALThe 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

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...

Countries:United Arab EmiratesUnited StatesSouth Africa
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Frequently asked questions about NVX-CoV2373

What is NVX-CoV2373 used for?

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.

What does NVX-CoV2373 target?

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.

Who makes NVX-CoV2373?

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.

What phase is NVX-CoV2373 in?

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.

What clinical trials is NVX-CoV2373 in?

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.

Is NVX-CoV2373 the same as a COVID-19 vaccine?

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.