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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special community-based training can increase COVID-19 vaccine and booster uptake among Black individuals with rheumatic conditions. The trial addresses vaccine hesitancy by training Popular Opinion Leaders (POLs) on vaccine facts, myths, and development. Participants are divided into two groups: one receives standard training, while the other receives an additional undisclosed component. This trial suits Black individuals who have received at least one COVID-19 vaccine dose after August 31, 2022, and their social network members who have not yet received the updated vaccine and remain undecided or unplanned to get it. As an unphased trial, it offers a unique opportunity to contribute to community health by exploring innovative strategies to improve vaccine uptake.

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 prior data suggests that this training is safe for increasing vaccine uptake?

Research shows that COVID-19 vaccines and boosters are generally well-tolerated by most people. Those with rheumatic diseases who have received these vaccines tend to experience better outcomes if they contract COVID-19. Studies have found that the vaccines lower the risk of severe illness in these patients.

Regarding safety, data indicate that side effects are usually mild and temporary, such as a sore arm, fatigue, or a mild fever. Serious side effects are rare. Since the vaccines have already been approved for use, they possess a strong safety record. This provides confidence in the vaccine's safety for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Vaccine Education for Rheumatic Diseases trial because it aims to enhance understanding and acceptance of COVID-19 vaccines among individuals with rheumatic diseases. Unlike standard educational approaches, this trial includes an undisclosed training component that might address specific barriers or misconceptions about vaccines, potentially leading to better vaccine uptake. By providing comprehensive information about the vaccine's development and debunking myths, this trial could empower patients to make informed health decisions, ultimately improving their protection against COVID-19.

What evidence suggests that this trial's treatments could be effective for increasing COVID-19 vaccine uptake among Black individuals with rheumatic conditions?

Research shows that COVID-19 vaccines and boosters reduce illness severity, especially for those with rheumatic diseases. One study found that booster shots greatly protected these individuals from severe COVID-19. Another study showed that the BNT162b2 mRNA vaccine effectively prevented COVID-19 infection in people with inflammatory rheumatic diseases. Vaccines have been proven to prevent nearly two-thirds of hospitalizations and more than half of severe cases. This trial will compare two training approaches: one group will receive COVID-19 vaccine and booster training, while another group will receive the same training with an extra undisclosed component. This evidence suggests that vaccination and boosters can protect people with rheumatic conditions from severe COVID-19. ^{2 6 7 8 9}

Who Is on the Research Team?

Rosalind Ramsey-Goldman, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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