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COVID-19 Vaccines for Rheumatic Diseases
Phase 4
Waitlist Available
Research Sponsored by Oregon Health and Science University
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 2 years
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will help to better understand the immunogenicity and safety of the Pfizer-BioNTech and Moderna COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies.
Who is the study for?
Adults in the US needing a COVID-19 booster, with or without active rheumatic disease. Those with rheumatic disease must be on stable doses of specific medications. People not eligible include those currently infected with SARS-CoV-2, severe vaccine allergies, prior adenoviral COVID-19 vaccination, HIV/AIDS, current cancer treatment, recent other vaccines, and significant illnesses reducing life expectancy.
What is being tested?
The trial is testing if people with rheumatic diseases can safely receive a COVID-19 booster alongside Hepatitis A and Diphtheria-Pertussis-Tetanus vaccines. It aims to understand how these vaccines interact and whether immune responses are affected by certain rheumatic disease treatments.
What are the potential side effects?
Potential side effects may include typical reactions to vaccinations such as soreness at injection site, fever, fatigue or allergic reactions. Specific risks related to combining these vaccines will also be monitored.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Upper arm
Upper arm
Upper arm
+20 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Active Control
Group I: Arm 2 (co-administration group)Active Control1 Intervention
Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.
This arm will receive co-administration of hepA vaccination.
Group II: Arm 4 (Inflammatory arthritis patients using DMARDS)Active Control1 Intervention
Individuals with inflammatory arthritis patients using DMARDS, who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.
This arm will only receive the standard of care COVID-19 booster vaccination.
Group III: Arm 3 (co-administration group)Active Control1 Intervention
Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.
This arm will receive co-administration of tdap booster vaccination.
Group IV: Arm 1 (control group, sequential administration)Active Control2 Interventions
Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination.
This arm will receive sequential administration of both tdap booster and hepA vaccinations.
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,843 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I see a rheumatologist but don't need strong medication for my condition.I have not had COVID-19 in the last 14 days.I am scheduled for a COVID-19 booster shot.I am 18 years old or older.I am currently undergoing radiation or chemotherapy for cancer.I have received an adenoviral COVID-19 vaccine.I meet the guidelines for receiving HAVRIX® and BOOSTRIX® vaccines.I have been vaccinated for diphtheria, pertussis, or tetanus in the last 9 years.I have HIV/AIDS.I have had whooping cough, diphtheria, tetanus, or hepatitis A.I do not have any illnesses that would limit my life to less than a year.I haven't had vaccines other than for COVID-19 close to my COVID-19 vaccination dates.I have inflammatory arthritis and am on a stable dose of my medication.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2 (co-administration group)
- Group 2: Arm 4 (Inflammatory arthritis patients using DMARDS)
- Group 3: Arm 3 (co-administration group)
- Group 4: Arm 1 (control group, sequential administration)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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