Clinical trial NCT05788510: Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy
Official title: Pneumococcal Vaccination in Patients with Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Vaccine
Keywords: Pneumococcal vaccine
Immunosupressed patients
Immunization status
Anti-TNF alpha
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having received anti-TNF alpha treatment between 2020 and 2022 at the NOVO Hospital - Pontoise site

Brief summary: As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital.

The aim of this study is to assess the status of pneumococcal vaccination in patients at the NOVO hospital - Pontoise site, who have received anti-TNF alpha therapy.

Detailed description: Immunosuppressed patients are at risk of infections, sometimes severe with life-threatening consequences. Some of these are vaccine-preventable, notably pneumococcal infections. Specific vaccination recommendations have been published since 2012 by the French High Council for Public Health. However, vaccine coverage is below the desired immunisation objectives for immunosuppressed patients.

As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital, in order to propose, if necessary, measures, in particular a specialised consultation, with the aim of improving the vaccination coverage of this population at risk The aim of this study is to assess the status of pneumococcal vaccination in patients who have received anti-TNF alpha therapy.

Eligibility criteria: Inclusion Criteria :

* Patients treated with anti-TNF alpha between 2020 and 2022 at the NOVO Hospital - Pontoise site

Exclusion Criteria :

* Patients with an indication for pneumococcal vaccination who have received a full vaccination regimen prior to the decision to start anti-TNF alpha

Primary outcomes:
measure: Evaluation of the prescription of a pneumococcal vaccination (Conjugated or Unconjugated Pneumococcal Vaccine) by doctors practising at the NOVO Hospital - Pontoise site, in patients receiving anti-TNF alpha treatment
timeFrame: At the end of the study, an average of one month
Secondary outcomes:
measure: Assessment of the timing of the vaccines (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) in relation to the date of initiation of anti-TNF alpha therapy
timeFrame: At the end of the study, an average of one month
measure: Assessment of the number of injections prescribed and/or performed (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) for each patient
timeFrame: At the end of the study, an average of one month
measure: Evaluation of the prescription or completion of the vaccination according to the characteristics of the patients and their comorbidities.
timeFrame: At the end of the study, an average of one month
measure: Evaluation of the prescription or completion of the vaccination according to the medical specialty of the prescriber
timeFrame: At the end of the study, an average of one month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Internal Medicine Department - NOVO Hospital - Pontoise site
Study officials:
affiliation: NOVO Hospital
name: Dr Christine Trumtel
role: PRINCIPAL_INVESTIGATOR
References: