Vaccine Education for Rheumatic Diseases

Overseen By Komel Safdar, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnant, Institutionalized, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

To establish the efficacy of a community-based POL (Popular Opinion Leader) intervention with two different trainings designed to increase COVID-19 vaccine and booster uptake and reduce hesitancy among social networks of Black individuals with rheumatic conditions. The investigators will also determine the structure and composition of the personal and outreach social networks of POLs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the COVID-19 vaccine and booster training treatment for patients with rheumatic diseases?

Research shows that COVID-19 vaccination is effective in protecting patients with rheumatic diseases from severe COVID-19 infection. Despite concerns about disease flare-ups, vaccination is recommended for these patients as they are at high risk for severe infection. ^{1 2 3 4 5}

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 any new or worsening symptoms being mild and manageable. Studies have focused on the safety of these vaccines in patients with conditions like systemic autoimmune rheumatic diseases and systemic vasculitis, and they have been well tolerated. ^{2 5 6 7 8}

How is the vaccine education treatment for rheumatic diseases different from other treatments?

This treatment focuses on educating patients with rheumatic diseases about COVID-19 vaccination, which is crucial as they are at higher risk for severe infection. Unlike other treatments that may involve medication or physical therapy, this approach emphasizes understanding and promoting vaccination as a preventive measure. ^{2 3 7 9 10}

Research Team

Rosalind Ramsey-Goldman, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for Black individuals aged 18-85 with rheumatic diseases who want to help their community understand COVID-19 vaccines better. They must speak English, identify as Black/African American/African descent, and have a social network. Members of this network should be adults not fully vaccinated against COVID.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

POLs receive training on COVID-19 vaccine and booster information, including background, development, and myths

6 months

Group training sessions

Community Outreach

POLs disseminate vaccine-related information to their social networks

6 months

Follow-up

Participants are monitored for changes in vaccine hesitancy and network structure

6 months

Treatment Details

Interventions

• COVID-19 Vaccine and Booster Training

Trial Overview The study tests two types of training given to Popular Opinion Leaders (POLs) in the Black community on the benefits of COVID-19 vaccines and boosters. The goal is to see if these trainings can increase vaccine uptake and reduce hesitancy within their networks.

Participant Groups

Group I: COVID-19 vaccine and booster training with extra undisclosed component Experimental Treatment 1 Intervention

Group training involving COVID-19 vaccine and booster information, including background, development, and myths. Contains extra training component that is undisclosed until the end of the study so as not to introduce bias.

Group II: COVID-19 vaccine and booster training Active Control 1 Intervention

Group training involving COVID-19 vaccine and booster information, including background, development, and myths.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Findings from Research

In a study of 479 children with rheumatic diseases, about 90% received at least one dose of a COVID-19 vaccine, and only 10.72% experienced a flare-up after vaccination, indicating that the vaccine is generally safe for this population.

The use of prednisolone at doses of 10 mg/day or more before vaccination was linked to a higher risk of flare-ups, suggesting that children on higher doses of this medication should be monitored closely after receiving the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes in children with rheumatic diseases following COVID-19 vaccination and infection: data from a large two-center cohort study in Thailand. Lerkvaleekul, B., Charuvanij, S., Sukharomana, M., et al.[2023]

Vaccination against COVID-19 is crucial for controlling the pandemic, especially for patients with rheumatic diseases who are at a higher risk of severe infection.

In 2021, the Chinese Rheumatology Association developed vaccination recommendations for adult patients with rheumatic diseases, integrating current data and international guidelines to prioritize their vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations on SARS-CoV-2 vaccination in adult patients with rheumatic diseases. Shen, M., Dong, L., Li, M., et al.[2022]

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]

The Pfizer/BioNTech (BNT162b2) mRNA vaccine showed lower immunogenicity in patients with systemic autoimmune rheumatic diseases (SARDs), particularly in those treated with immunosuppressants like rituximab, mycophenolate mofetil, and prednisone, with only 69.9% of SARDs patients being seropositive compared to 96.8% in non-immunosuppressed SARDs patients.

Adverse effects such as fever and musculoskeletal symptoms were more common in seropositive patients, suggesting that these reactions may indicate a successful immune response to the vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients. Pri-Paz Basson, Y., Tayer-Shifman, OE., Naser, R., et al.[2023]

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]

Vaccination against SARS-CoV-2 is strongly recommended for people with rheumatic diseases (PRD) and their household contacts, emphasizing the importance of individualizing vaccination plans in consultation with healthcare providers.

For patients on immunomodulatory drugs, including rituximab, specific timing for vaccination is advised to optimize efficacy, such as administering the vaccine during quiescent disease and at least 6 months after the last rituximab dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for COVID-19 vaccination in people with rheumatic disease: Developed by the Singapore Chapter of Rheumatologists. Santosa, A., Xu, C., Arkachaisri, T., et al.[2021]

In a study involving 107 patients with systemic vasculitis and 107 healthy controls, only one patient (0.93%) experienced a disease flare after receiving the first dose of an mRNA anti-SARS-CoV-2 vaccine, indicating a low risk of exacerbation in this population.

There were no significant differences in adverse events between patients with systemic vasculitis and healthy controls after vaccination, and no serious adverse events were reported, suggesting that the vaccine is safe for individuals with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicentre case-control study evaluating the safety of anti-SARS-CoV-2 vaccines in a cohort of patients with systemic vasculitis. Simoncelli, E., Conticini, E., Colafrancesco, S., et al.[2023]

A task force of experts developed 74 consensus statements to guide rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases, despite limited direct evidence.

The guidance includes recommendations on the timing of immunomodulatory therapies in relation to vaccination, aiming to optimize vaccine efficacy and safety for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2. Curtis, JR., Johnson, SR., Anthony, DD., et al.[2022]

A task force of experts developed 74 consensus statements to guide rheumatology providers on the use of COVID-19 vaccines for patients with rheumatic and musculoskeletal diseases, despite limited direct evidence.

The guidance includes recommendations on the timing of immunomodulatory therapies in relation to vaccination, aiming to optimize vaccine efficacy and safety for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Curtis, JR., Johnson, SR., Anthony, DD., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes in children with rheumatic diseases following COVID-19 vaccination and infection: data from a large two-center cohort study in Thailand. [2023]

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

Recommendations on SARS-CoV-2 vaccination in adult patients with rheumatic diseases. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

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

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of the mRNA-based BNT162b2 vaccine in systemic autoimmune rheumatic diseases patients. [2023]

6. 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]

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

Recommendations for COVID-19 vaccination in people with rheumatic disease: Developed by the Singapore Chapter of Rheumatologists. [2021]

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

Multicentre case-control study evaluating the safety of anti-SARS-CoV-2 vaccines in a cohort of patients with systemic vasculitis. [2023]

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

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 2. [2022]

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

American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. [2022]