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: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new COVID-19 booster shot (NVX-CoV2372) to determine its effectiveness in boosting the immune response in individuals with weakened immune systems. It targets those with inflammatory bowel disease, such as Crohn's or ulcerative colitis, or those who have undergone a solid organ transplant, like a kidney or liver. Participants should have received at least three doses of a COVID-19 vaccine. Individuals with these conditions who are on specific treatments may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop your current medications. In fact, it specifies that participants should be on certain medications for IBD or as solid organ transplant recipients.

Is there any evidence suggesting that NVX-CoV2372 is likely to be safe for humans?

Research has shown that the NVX-CoV2372 vaccine, also known as the Novavax COVID-19 vaccine, is generally safe. Most recipients did not experience serious side effects. In studies, various groups tolerated the vaccine well. Some individuals reported mild to moderate side effects, such as pain at the injection site, tiredness, and headache, which typically resolved quickly.

For individuals with inflammatory bowel disease (IBD) or those who have undergone organ transplants, specific safety data on NVX-CoV2372 remains limited. However, the vaccine has demonstrated good safety results in other groups. Additionally, its approval for use in other conditions suggests general safety.

Overall, while specific data for people with weakened immune systems is limited, existing research provides some confidence in its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NVX-CoV2372 because it offers a promising new approach for boosting immunity in immunocompromised individuals. Unlike traditional mRNA or viral vector vaccines, NVX-CoV2372 is a protein-based vaccine, which can provide a robust immune response with potentially fewer side effects. This vaccine uses recombinant nanoparticle technology to introduce a stabilized form of the SARS-CoV-2 spike protein, aiming to enhance the immune response specifically in individuals with conditions like solid organ transplants or inflammatory bowel disease (IBD). This unique method could lead to better protection for those who are typically less responsive to standard vaccines.

What evidence suggests that this treatment might be an effective treatment for COVID-19 in immunocompromised individuals?

Research has shown that the NVX-CoV2372 vaccine is safe and generates a strong immune response across various groups. This trial will assess its effectiveness in immunocompromised individuals, specifically those who have undergone solid organ transplants and those with inflammatory bowel disease (IBD). For participants with IBD, evidence indicates that COVID-19 vaccines are generally safe and effective, though specific data for this group remains limited. In contrast, individuals who have had organ transplants may exhibit weaker immune responses, but studies suggest that vaccines like NVX-CoV2372 can bolster their immunity. Overall, current evidence supports the potential of NVX-CoV2372 to enhance immunity in these vulnerable groups. ^{2 5 6 7 8}

Who Is on the Research Team?

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.

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.

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?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X2500074X

Efficacy, immunogenicity, and safety of the Novavax COVID ... Overall, the Novavax COVID-19 vaccine was immunogenic and had a tolerable safety profile across diverse populations of IIC; some outcomes varied ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8441891/

SARS‐CoV‐2 vaccination in patients with inflammatory ... Data regarding the efficacy of available SARS‐CoV‐2 vaccinations in immunosuppressed or immunocompromised patients, including those with IBD, are limited but ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/29/NCT06027229/Prot_SAP_000.pdf

Additional Recombinant COVID-19 Humoral and Cell Adults with established IBD on immunosuppression age 18-85 years and/or solid organ transplant recipients on systemic immunosuppressive therapy.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/17562848231173130

COVID-19 vaccination in adults with inflammatory bowel ... Most patients with IBD are not at increased risk for severe COVID-19 infection and that vaccines are both safe and effective in this population.

5. mdpi.com mdpi.com/2076-393X/11/10/1523

COVID-19 Immunization Rates in Patients with ... The pooled prevalence of COVID-19 vaccine uptake was estimated at 72% (95%CI = 59–83%) for at least one dose, 81% (95%CI = 68–91%) for the complete vaccination ...

6. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-and-Patient-Package-Insert-NUVAXOVID.pdf

Package Insert and Patient Package Insert - NUVAXOVID COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). 76. Safety data accrued in Studies 1, 5, 6, and 7 are relevant to NUVAXOVID because the vaccines. 77.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10895915/

COVID-19 Disease Risk and Vaccine Safety and Efficacy Studies evaluating COVID-19 vaccine safety in this population have overall provided data that vaccination is extremely safe.

8. fda.gov fda.gov/media/168233/download

Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 ... Solid organ transplant patients are immunosuppressed due to the effects of immunosuppressive ... No clinical safety data for Novavax COVID-19 ...