21 Participants Needed

COVID-19 Booster Vaccine for Immunocompromised Individuals

CT
Overseen ByClinical Trials Institute
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Wisconsin, Madison
Must be taking: Thiopurines, Anti-TNFs, Vedolizumab, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

FC

Freddy Caldera, DO, MS

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline visit where blood samples are collected before the booster dose

1 day
1 visit (in-person)

Treatment

Participants receive a recombinant COVID-19 vaccine booster dose

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood samples collected at 1 month and 6 months post-booster

6 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Participants with IBDExperimental Treatment1 Intervention
Group II: Participants who have had Solid Organ TransplantsExperimental Treatment1 Intervention

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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