COVID-19 Booster Vaccine for Immunocompromised Individuals

Overseen By Clinical Trials Institute

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must be taking: Thiopurines, Anti-TNFs, Vedolizumab, others

Disqualifiers: Pregnancy, Lactation, Active COVID-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Freddy Caldera, DO, MS

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

This trial is for people with Inflammatory Bowel Disease or those who've had an organ transplant and have already received a COVID-19 vaccine. They should be on specific treatments for their condition but can't join if they've had recent organ rejection, allergies to the vaccine, are pregnant/breastfeeding, recently used steroids for IBD flare-ups, or currently have COVID-19.

Inclusion Criteria

I am either not able to have children or have been using effective birth control.

I have received a solid organ transplant.

I am currently on a specific treatment for IBD or I am a solid organ transplant recipient.

Exclusion Criteria

Allergy to recombinant COVID-19 vaccine or any component of it

Patient cannot or will not provide written informed consent

I have had an immune system rejection in the last 6 months.

Treatment Details

Interventions

• NVX-CoV2372

Trial Overview The study tests if a recombinant booster shot (NVX-CoV2372) enhances immune response against COVID-19 in immunosuppressed patients over six months. It involves 120 participants with either IBD or solid organ transplants to see how well their bodies can fight off the virus after getting this extra dose.

Participant Groups

Group I: Participants with IBD Experimental Treatment 1 Intervention

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

Group II: Participants who have had Solid Organ Transplants Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Novavax

Industry Sponsor

Trials

51

Recruited

111,000+