COVID-19 Vaccines for Rheumatic Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines.Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications if you are in the Rheumatic Disease arm, as long as you are on stable doses of certain medications for at least 30 days before joining. The protocol does not specify for other participants.
Is the COVID-19 vaccine safe for people with rheumatic diseases?
How do COVID-19 vaccines differ from other treatments for rheumatic diseases?
COVID-19 vaccines are unique for rheumatic diseases because they are designed to prevent infection from the coronavirus, rather than directly treating the rheumatic condition itself. They work by stimulating the immune system to recognize and fight the virus, which is different from typical treatments for rheumatic diseases that often focus on reducing inflammation or suppressing the immune system.678910
What data supports the effectiveness of the treatment Diphtheria, pertussis, and tetanus booster vaccine, Hepatitis A vaccine for COVID-19 in patients with rheumatic diseases?
Vaccinations are recommended for patients with rheumatic diseases to reduce the risk of infections, as they are particularly vulnerable. National and international guidelines support the safe and effective use of vaccines in these patients, suggesting that vaccines can help protect them from infections.811121314
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a SARS-CoV-2 booster vaccine, with some receiving co-administration of other vaccines such as tdap and hepA
Follow-up
Participants are monitored for safety and effectiveness after receiving the booster vaccine
What Are the Treatments Tested in This Trial?
Interventions
- Diphtheria, pertussis, and tetanus booster vaccine
- Hepatitis A vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor