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OpenTrials
Completed

NCT Number: NCT05115370

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

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.

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Key information

Conditions

Inflammatory Disease Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Infectious Arthritis, Psoriatic Arthritis, Reactive Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Cardiovascular Diseases Chronic Disease Connective Tissue Diseases Digestive System Diseases Disease Attributes Gastroenteritis Gastrointestinal Diseases Immune System Diseases Infections Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders Psoriasis Psoriatic Arthritis Reactive Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Systemic Lupus Erythematosus Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nottingham

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semi-structured qualitative interview

Other

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

Primary outcomes

  1. 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

    Time frame: 1 day

    This will be determined through interview

  2. Participants' understanding regarding vaccinations for these infections and how they work

    Time frame: 1 day

    This will be determined through interview

  3. Participants' views about the perceived benefits and risks of vaccination for these infections

    Time frame: 1 day

    This will be determined through interview

  4. The reasons for vaccine uptake versus vaccine hesitancy

    Time frame: 1 day

    This will be determined through interview

  5. The impact of the Covid-19 pandemic on perceptions and engagement with routinely administered vaccinations in this population.

    Time frame: 1 day

    This will be determined through interview

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: OPINION

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2021
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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