Vaccination Perception in Inflammatory Conditions - Flu, Pneumonia and COVID-19

Rheumatoid Arthritis Clinical Trial

— OPINION  

Official title:

Barriers and Facilitators of Flu, Pneumonia and SARS-CoV-2 (COVID-19) Vaccination in Adults With Inflammatory Conditions Treated With Immune-suppressing Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115370
• Other study ID #: 21054
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: October 2021
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

People with inflammatory diseases are often treated with medications that act to suppress the immune-system, increasing the risk of catching infections. Consequently, vaccination with the pneumonia and seasonal flu vaccines is recommended for them. They were also prioritised to receive the COVID-19 vaccines early in the national rollout. However, the uptake of the pneumonia and seasonal flu vaccines among this group is lower than ideal. There may be many reasons why they do or do not seek to be vaccinated for these infections, such as the belief it may cause their disease to flare up or lack of knowledge of vaccines effectiveness. Anecdotally there was a high uptake of COVID-19 vaccines in adults with inflammatory conditions, however, concerns about vaccine-induced disease flare-ups and reports of complications deterred some from being vaccinated. A better understanding of why people do and do not seek vaccination may result in more targeted messaging for patients to help overcome vaccine hesitancy for these infectious diseases. This study aims to explore the drivers and barriers to being vaccinated among adults with common inflammatory conditions and on immune-suppressing medication. They will be invited to participate in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour, and digitally audio-recorded. They will explore participants' understanding of pneumonia, seasonal flu and COVID-19 and the risk they pose to their health, their understanding of vaccinations, beliefs of the benefits and risks of vaccinations for these infections, and reasons for seeking or not seeking vaccination. Findings will inform messaging about being vaccinated for these infections in patient education leaflets, such as those by patient charities regularly provided at speciality clinics. They will also be disseminated to healthcare professionals to help them better understand the drivers and barriers to vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age at-least 18 years,
• Diagnosed with either rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, vasculitis (small or large vessel), or reactive arthritis, and
• At-least one prescription of either methotrexate, azathioprine, 5-mercaptopurine, sulfasalazine, mycophenolate mofetil, leflunomide, ciclosporin, tacrolimus, or sirolimus, biologic agents (such as anti-TNF, anti-CD 20 etc).
• Ability to give informed consent

Exclusion Criteria:

• Age < 18 years
• Dementia: making it impossible to give informed consent and to comply with interview

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Reactive
• Inflammatory Bowel Diseases
• Inflammatory Disease
• Lupus Erythematosus, Systemic
• Pneumonia
• Psoriatic Arthritis
• Reactive Arthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing
• Systemic Lupus Erythematosus
• Vasculitis

Intervention

Other:
• Semi-structured qualitative interview
A single semi-structured qualitative interview conducted face-to-face or by telephone or video-conference call.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' understanding of the flu, pneumonia and Covid-19 respiratory infections and the risks they pose to the health and well-being of people on immune-suppressing treatments	This will be determined through interview	1 day
Primary	Participants' understanding regarding vaccinations for these infections and how they work	This will be determined through interview	1 day
Primary	Participants' views about the perceived benefits and risks of vaccination for these infections	This will be determined through interview	1 day
Primary	The reasons for vaccine uptake versus vaccine hesitancy	This will be determined through interview	1 day
Primary	The impact of the Covid-19 pandemic on perceptions and engagement with routinely administered vaccinations in this population.	This will be determined through interview	1 day