Clinical trial NCT05115370: Vaccination Perception in Inflammatory Conditions - Flu, Pneumonia and COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Disease
Rheumatoid Arthritis
Psoriatic Arthritis
Systemic Lupus Erythematosus
Ankylosing Spondylitis
Vasculitis
Reactive Arthritis
Inflammatory Bowel Diseases
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an inflammatory condition and on immune-suppressing medication

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 day
measure: Participants' understanding regarding vaccinations for these infections and how they work
timeFrame: 1 day
measure: Participants' views about the perceived benefits and risks of vaccination for these infections
timeFrame: 1 day
measure: The reasons for vaccine uptake versus vaccine hesitancy
timeFrame: 1 day
measure: The impact of the Covid-19 pandemic on perceptions and engagement with routinely administered vaccinations in this population.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Abhishek Abhishek
role: PRINCIPAL_INVESTIGATOR
References: