Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations

NCT06027229 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: 2023-1208Protocol Version 10/5/2024SMPH/MEDICINE/GASTROENTA534250
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether providing a recombinant booster COVID-19 vaccine improves sustained humoral and cell-mediated immunogenicity against SARS-CoV-2 in immunosuppressed patients with Inflammatory Bowel Disease (IBD) and/or solid organ transplant recipients. 120 participants will be enrolled and can expect to be on study for 6 months.

Conditions

Immunosuppression; COVID-19

Keywords

Immunogenicity; IBD; solid organ transplant

Outcome Measures

Primary Outcomes (1)

• Change in Antibody Concentration From Baseline (Visit 1) at 1 Month (Visit 2)

  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).

  baseline and 1 month

Secondary Outcomes (10)

• 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

• Change in Interferon Gamma Responses at 6 Months Compared to 1 Month

  1 month, 6 months

• Solicited Adverse Events (AEs)

  up to 7 days on study

Study Arms (2)

Participants who have had Solid Organ Transplants

EXPERIMENTAL

Male and females aged 18 to 85 who are solid organ transplant recipients and receive the study intervention.

Biological: NVX-CoV2372

Participants with IBD

EXPERIMENTAL

Male and females aged 18 to 85 who have IBD and receive the study intervention.

Biological: NVX-CoV2372

Interventions

NVX-CoV2372 BIOLOGICAL

Novavax COVID-19 Vaccine Booster for Omicron XBB.1.5

Also known as: Novavax COVID-19 Vaccine

Participants who have had Solid Organ Transplants; Participants with IBD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Have received at least three doses of a COVID-19 vaccine.
• Three messenger RNA (mRNA) vaccines, or
• One or two viral vector vaccine and one or two mRNA vaccines.
• Female participant of non-childbearing potential (pre-menarche, current tubal ligation, hysterectomy, oophorectomy or post-menopause) and childbearing potential (if they had: practiced adequate contraception for 1 month prior to vaccination and agreement to use such for an additional 8 weeks after administration of the Novavax COVID-19 vaccine). Non-pregnant females with a negative pregnancy test who are willing to practice adequate contraception 8 weeks after administration of the Novavax COVID-19 vaccine.
• On one of the following treatment regimens
• IBD
• Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
• Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks), or certolizumab (at least monthly)
• Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg.
• Vedolizumab Therapy Group: either vedolizumab monotherapy at least every 8 week dosing or combination therapy Group: on vedolizumab therapy at with azathioprine or methotrexate
• Ustekinumab Therapy Group: either ustekinumab monotherapy or combination therapy with methotrexate or azathioprine.
• Tofacitinib Therapy Group: on tofacitinib at least 5mg orally, twice per day
• Risankizumab Therapy: 360mg at least every 8 weeks

You may not qualify if:

• Allergy to recombinant COVID-19 vaccine or any component of it
• Patient cannot or will not provide written informed consent.
• Unable to provide appropriate informed consent because of illiteracy or impairment in decision-making capacity.
• Active antibody-mediated or cellular rejection within the past six months
• Recent IBD flare requiring initiation of systemic corticosteroids within the past month.
• Previous history of myocarditis or pericarditis ever.
• Patients who are pregnant
• Patients who are lactating
• Patients with an active COVID-19 infection
• Patients with a COVID-19 infection within the past two months

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Novavax: collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Freddy Caldera, DO, PhD, MS
• Organization: UW School of Medicine and Public Health

fcaldera@medicine.wisc.edu

(608) 263-1995

Study Officials

• Freddy Caldera, DO, MS

  UW School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: November 20, 2023
• Primary Completion: April 24, 2024
• Study Completion: September 9, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)