COVID-19 Vaccines for Rheumatic Diseases

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how COVID-19 vaccines function in individuals with rheumatic diseases, particularly those using medications that might weaken immune responses. The researchers aim to determine if these vaccines can be safely and effectively administered alongside routine vaccines, such as those for tetanus (diphtheria, pertussis, and tetanus booster) and hepatitis A. The study seeks to understand the safety and immune response in individuals with conditions like rheumatoid or psoriatic arthritis who are on stable medication doses. Those with rheumatoid arthritis or similar conditions scheduled for a COVID-19 booster may be suitable participants, especially if they have not recently received vaccinations for diphtheria, pertussis, tetanus, or hepatitis A. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for a broader patient population.

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.

What is the safety track record for these treatments?

Research has shown that the booster vaccine for diphtheria, pertussis, and tetanus is generally safe and effective. Side effects may occur but are usually mild, such as soreness at the injection site or a mild fever.

For the hepatitis A vaccine, studies indicate it is safe for individuals with rheumatic diseases and is recommended for those at risk of infection. Although some reports suggest vaccines might trigger or worsen autoimmune conditions, these cases appear rare.

These vaccines are widely used and approved, indicating a strong safety record. However, individuals should discuss potential risks with their healthcare provider, especially if they have existing health conditions. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the COVID-19 booster co-administration with the diphtheria, pertussis, and tetanus (Tdap) booster and Hepatitis A vaccines because it streamlines vaccination processes for individuals with chronic conditions. Unlike the standard sequential administration, this co-administration could enhance convenience, potentially improving vaccination rates by reducing the number of healthcare visits. Additionally, exploring these combinations may provide insights into immune system responses and safety when multiple vaccines are administered together. This could lead to more efficient vaccination strategies, especially for vulnerable populations, without compromising safety or effectiveness.

What evidence suggests that this trial's treatments could be effective for rheumatic diseases?

Research shows that the diphtheria, pertussis, and tetanus (dT) booster vaccine is highly effective. Studies indicate that 99.6% to 100% of healthy adults become immune to diphtheria, and 97.5% to 98.2% become immune to tetanus after vaccination. For pertussis, protection remains strong in children. The hepatitis A vaccine also proves effective, with two doses protecting most patients with rheumatoid arthritis, even if their immune systems are weaker. Long-term studies reveal that 86% of vaccinated individuals maintain protective antibody levels. In this trial, some participants will receive these vaccines alongside a COVID-19 booster, while others will receive them sequentially or only the COVID-19 booster. Both vaccines effectively trigger the body's immune response, even in those with rheumatic diseases. ^{6 7 8 9 10}

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

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 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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X22007605

Long-term persistence of antibodies after diphtheria ... The diphtheria/tetanus (dT) vaccination possesses high effectiveness. Research indicates that 99.6–100% and 97.5–98.2% of healthy adults develop ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5919600/

Prevention of Pertussis, Tetanus, and Diphtheria with ... Vaccination coverage with DTaP in children aged 19–35 months remains consistently high, at 95.0% for ≥3 DTaP doses and 84.6% for ≥4 DTaP doses reported in 2015 ...

3. ard.bmj.com ard.bmj.com/content/80/10/1255

Impact of disease-modifying antirheumatic drugs on ... Disease-modifying antirheumatic drugs may reduce the immunogenicity of common vaccines. We will review here available data regarding the effect of these ...

4. jscimedcentral.com jscimedcentral.com/jounal-article-info/Journal-of-Preventive-Medicine-and-Health-Care/Vaccination-Coverage-in-Children-with-Rheumatic-Diseases-at-a-Tertiary-Pediatric-Center-Challenges-and-Opportunities-12019

Vaccination Coverage in Children with Rheumatic ... Results: The overall vaccination rate was 75% (N = 80). The most commonly missed vaccines were the second doses of MMR (15%) and VAR (11%).

5. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1043707/full

Diphtheria, tetanus, and pertussis immunity among ... IgG against diphtheria was found in 99.5% of pregnant women, tetanus in 91.5%, and pertussis in only 36.5%. According to the results of the ...

6. cdc.gov cdc.gov/vaccine-safety/vaccines/dtap-tdap.html

Diphtheria, Tetanus, and Pertussis Vaccine Safety DTaP and Tdap vaccine are safe and effective at preventing diphtheria, tetanus, and pertussis. Vaccines, like any medicine, can have side effects.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5042271/

Vaccination recommendations for adult patients with ... This review will consider the immunization process followed in rheumatic diseases and also refer to its application.

8. webmd.com webmd.com/vaccines/tdap-vaccine-for-adults

Adult Tetanus, Diphtheria, Pertussis (Td, Tdap) Vaccine Tdap is a common vaccine that protects you against three serious bacterial infections: tetanus, diphtheria, and pertussis (whooping cough).

9. cdc.gov cdc.gov/mmwr/volumes/67/rr/rr6702a1.htm

Prevention of Pertussis, Tetanus, and Diphtheria with ... Data on the safety of two closely spaced doses of tetanus toxoid–containing vaccines were limited to receipt of Td and Tdap or Tdap-IPV vaccine ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30877773/

Safety and immunogenicity of tetanus/diphtheria ... Conclusion: Diphtheria/tetanus booster vaccination was safe. Tetanus vaccination was immunogenic; the diphtheria component was less immunogenic.