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Virus Therapy

COVID-19 Booster Vaccine for Immunocompromised Individuals

Q: Is my eligibility sufficient to join this research project?

To be eligible for this clinical trial, potential participants must have a confirmed case of <a href="https://www.withpower.com/clinical-trials/covid">COVID</a>-19 and should fall between 18 to 85 years old in age. This research initiative is looking to recruit 120 individuals.

Q: Is the age bracket for this medical study limited to adults under 45 years old?

Per the requirements listed on clinicaltrials.gov, prospective patients must range in age from 18 to 85 years old; however, there is an abundance of studies for those younger/older than this bracket with 105 and 658 respectively.

Q: Are individuals able to apply for this clinical trial at present?

This medical trial, which was initially posted on September 1st 2023 and last modified a day later, is no longer recruiting patients. However, 752 other studies are actively seeking participants at this time.

Q: Is the administration of Solid Organ Transplants to participants sanctioned by the FDA?

Our research team assigned a rating of 2 to the safety profile for patients who have had Solid Organ Transplants, due to the lack of clinical data proving efficacy while there is some evidence supporting their safety.

Phase 2

Recruiting

Led By Freddy Caldera, DO, MS

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month, 6 months

Awards & highlights

Study Summary

This trial tests if a booster COVID-19 vaccine helps immunosuppressed people with IBD and/or organ transplants protect against SARS-CoV-2. 120 people will be enrolled for 6 months.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not specified here, common side effects of vaccines like NVX-CoV2372 may include pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea. Severe allergic reactions are rare but possible.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Antibody Concentration from Baseline (visit 1) at 1 month (visit 2)

Secondary outcome measures

Interferon gamma responses at 1 month compared to baseline

Interferon gamma responses at 6 months compared to 1 month

Number of participants reporting acute rejection of their transplant

+7 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Participants with IBDExperimental Treatment1 Intervention

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

Group II: Participants who have had Solid Organ TransplantsExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,411 Total Patients Enrolled

14 Trials studying COVID-19

1,667,085 Patients Enrolled for COVID-19

NovavaxIndustry Sponsor

46 Previous Clinical Trials

106,444 Total Patients Enrolled

17 Trials studying COVID-19

71,275 Patients Enrolled for COVID-19

Freddy Caldera, DO, MSPrincipal InvestigatorUW School of Medicine and Public Health

3 Previous Clinical Trials

536 Total Patients Enrolled

1 Trials studying COVID-19

222 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my eligibility sufficient to join this research project?

"To be eligible for this clinical trial, potential participants must have a confirmed case of COVID-19 and should fall between 18 to 85 years old in age. This research initiative is looking to recruit 120 individuals."

Answered by AI

Is the age bracket for this medical study limited to adults under 45 years old?

"Per the requirements listed on clinicaltrials.gov, prospective patients must range in age from 18 to 85 years old; however, there is an abundance of studies for those younger/older than this bracket with 105 and 658 respectively."

Answered by AI

Are individuals able to apply for this clinical trial at present?

"This medical trial, which was initially posted on September 1st 2023 and last modified a day later, is no longer recruiting patients. However, 752 other studies are actively seeking participants at this time."

Answered by AI

Is the administration of Solid Organ Transplants to participants sanctioned by the FDA?

"Our research team assigned a rating of 2 to the safety profile for patients who have had Solid Organ Transplants, due to the lack of clinical data proving efficacy while there is some evidence supporting their safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Additional Recombinant COVID-19 Humoral and Cell-Mediated Immunogenicity in Immunosuppressed Populations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027229.

All > Covid 19