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NVX-CoV2372

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06027229Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed PopulationsPHASE2 COMPLETED 21Nov 20, 2023Sep 9, 2024Oct 20, 20251 United States
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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 — 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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