COVID-19 Vaccines for Rheumatic Diseases

Recruiting at 12 trial locations

Overseen By David Ridley, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must be taking: TNF antagonists, B-cell depletion

Must not be taking: Chemotherapy, Radiation

Disqualifiers: HIV/AIDS, Active SARS-CoV-2, 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: 1

Duration: 8 days

129 Participants Needed

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?

Research shows that COVID-19 vaccines are generally safe for people with rheumatic diseases, with common side effects like injection site pain, headache, fever, muscle pain, and fatigue. Serious issues like disease flare-ups are rare, occurring in a small percentage of patients. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{8 11 12 13 14}

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

I see a rheumatologist but don't need strong medication for my condition.

Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol

Must live in the United States

Exclusion Criteria

I have not had COVID-19 in the last 14 days.

Patients who have a previous history of pericarditis/myocarditis associated with vaccination

Any other reason that would interfere with required study related evaluations

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a SARS-CoV-2 booster vaccine, with some receiving co-administration of other vaccines such as tdap and hepA

8 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after receiving the booster vaccine

2 years

Periodic visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Diphtheria, pertussis, and tetanus booster vaccine
• Hepatitis A vaccine

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 2 (co-administration group) Active Control 1 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 Control 1 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 Control 1 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 Control 2 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.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study of 30 patients who developed rheumatic diseases (RDs) within 30 days after receiving an anti-COVID-19 vaccine, 80% experienced new onsets of RDs, with inflammatory arthritis being the most common manifestation.

Despite the occurrence of these RDs, the majority of patients (83.3%) responded well to treatment, indicating that while there may be some adverse events associated with vaccination, they are generally mild and manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New onset and flare of rheumatic diseases following COVID-19 vaccination are mild and respond well to treatment: 9-month follow-up data from a single centre cohort. Gasparotto, M., Bindoli, S., Padoan, R., et al.[2023]

The Canadian Rheumatology Association recommends COVID-19 vaccination for patients with autoimmune rheumatic diseases (ARD), emphasizing that the health benefits generally outweigh potential risks, despite low certainty in the evidence.

The panel concluded that patients with ARD should not face additional barriers to vaccination compared to those without ARD, and they provided guidance on medication management and monitoring vaccine uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian Rheumatology Association Recommendation for the Use of COVID-19 Vaccination for Patients With Autoimmune Rheumatic Diseases. Hazlewood, GS., Pardo, JP., Barnabe, C., et al.[2021]

Among 641 patients with rheumatic diseases surveyed, 65% were willing to receive the SARS-CoV-2 vaccine, indicating a significant level of vaccine hesitancy (34.4%) linked to concerns about safety and potential disease flare-ups.

Vaccine acceptance was positively influenced by prior vaccinations and clinician recommendations, suggesting that addressing patient concerns and allowing choice in vaccine options could enhance acceptance rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SARS-COV-2 vaccine acceptance in patients with rheumatic diseases: a cross-sectional study. Ko, T., Dendle, C., Woolley, I., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Infection prophylaxis in antirheumatic therapy: emphasis on vaccination. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[Rheumatic diseases and vaccination]. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Specific Cellular and Humoral Response after the Third Dose of Anti-SARS-CoV-2 RNA Vaccine in Patients with Immune-Mediated Rheumatic Diseases on Immunosuppressive Therapy. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of immunomodulating treatment on the immunogenicity of COVID-19 vaccines in patients with immune-mediated inflammatory rheumatic diseases compared to healthy controls. A Swedish nationwide study (COVID19-REUMA). [2023]

5. England pubmed.ncbi.nlm.nih.gov

Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of tetanus/diphtheria vaccination in patients with rheumatic diseases-a prospective multi-centre cohort study. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Low frequency of disease flare in patients with rheumatic musculoskeletal diseases who received SARS-CoV-2 mRNA vaccine. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Reactogenicity, safety and disease flares following BNT162b2 mRNA COVID-19 vaccine in patients with chronic immune-inflammatory arthritis treated with biological and targeted synthetic disease-modifying anti-rheumatic drugs. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Data on Post Market Safety Profiles of COVID 19 Vaccines in Rheumatic Diseases: Assessments on Various Vaccines in Use, Different Rheumatic Disease Subtypes, and Immunosuppressive Therapies: A Two-Centers Study. [2021]

10. Italy pubmed.ncbi.nlm.nih.gov

New onset and flare of rheumatic diseases following COVID-19 vaccination are mild and respond well to treatment: 9-month follow-up data from a single centre cohort. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Canadian Rheumatology Association Recommendation for the Use of COVID-19 Vaccination for Patients With Autoimmune Rheumatic Diseases. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 4. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 5. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

SARS-COV-2 vaccine acceptance in patients with rheumatic diseases: a cross-sectional study. [2022]