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NVX-CoV2372

Phase 2

Immunosuppression | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Oct 20, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

NVX-CoV2372 · 1 trial · 2 indications

Phase 2 1
NCT06027229Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed PopulationsImmunosuppression
COMPLETED21 Analytics
PHASE2COMPLETED
Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations
ImmunosuppressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2)
baseline and 1 month

Antibody concentrations 1 month after the recombinant vaccine booster (V2) in patients with IBD and solid organ transplant recipients compared to their baseline visit (V1).

Secondary Endpoints

Seropositivity Rates
baseline, 1 month, 6 months
Percent of Participants Seronegative at Baseline and Subsequently Seropositive
baseline, 1 month, 6 months
Change in Interferon Gamma Responses at 1 Month Compared to Baseline
baseline and 1 month
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Participants who have had Solid Organ TransplantsEXPERIMENTALMale and females aged 18 to 85 who are solid organ transplant recipients and receive the study intervention.
Participants with IBDEXPERIMENTALMale and females aged 18 to 85 who have IBD and receive the study intervention.

Interventions

NameTypeDescription
NVX-CoV2372BIOLOGICALNovavax COVID-19 Vaccine Booster for Omicron XBB.1.5
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: • Patient has a history of ulcerative colitis (UC), Crohn's disease, pouchitis, or indeterminate colitis diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria. And / or patient is a solid organ transplant recipient (e.g. lung, kidney, liver) * ...

Countries:United States
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Frequently asked questions about NVX-CoV2372

What is NVX-CoV2372 used for in immunosuppression?

NVX-CoV2372 is an investigational monoclonal antibody being studied for use in immunosuppressed populations, specifically to evaluate humoral and cell-mediated immunogenicity related to COVID-19. It is being developed as a potential intervention for individuals with immunosuppression, a condition that can weaken the body's immune response to infections.

Who makes NVX-CoV2372?

NVX-CoV2372 is developed by Novavax, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol NVAX. The company is conducting clinical research on this investigational monoclonal antibody for use in immunosuppressed populations.

What phase is NVX-CoV2372 in?

NVX-CoV2372 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in immunosuppressed populations.

What clinical trials is NVX-CoV2372 in?

NVX-CoV2372 has one completed clinical trial, identified as NCT06027229, titled "Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations." This Phase 2 study enrolled 21 participants in the United States and evaluated the drug's immunogenicity in immunosuppressed individuals.

Is NVX-CoV2372 the same as a COVID-19 vaccine?

NVX-CoV2372 is a monoclonal antibody, not a vaccine. It is being studied for its ability to generate humoral and cell-mediated immune responses in immunosuppressed populations, potentially offering a different approach to addressing COVID-19 in individuals with weakened immune systems.