TNF-VAX: Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy

Sponsor
Centre Hospitalier René Dubos (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05788510
Collaborator
(none)
105
1
30
106.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pneumococcal vaccine

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
105 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Pneumococcal vaccine

Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy

Other: Pneumococcal vaccine
Investigation of vaccination status, for Pneumococcal vaccine , of patients who received anti-TNF alpha therapy

Outcome Measures

Primary Outcome Measures

  1. 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 [At the end of the study, an average of one month]

    Presence or absence of a prescription or completion of a complete pneumococcal vaccination (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) recorded in the patient's medical file.

Secondary Outcome Measures

  1. 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 [At the end of the study, an average of one month]

    Number of patients who received a complete pneumococcal vaccination before initiation of treatment and the number of patients who received it after

  2. Assessment of the number of injections prescribed and/or performed (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) for each patient [At the end of the study, an average of one month]

    Number of patients who received an incomplete vaccination scheme (1 dose of Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent).

  3. Evaluation of the prescription or completion of the vaccination according to the characteristics of the patients and their comorbidities. [At the end of the study, an average of one month]

    Analysis of the data to identify any significant differences according to the characteristics of the vaccinated and non-vaccinated patients (comorbidities, pathology for which the treatment was introduced .....).

  4. Evaluation of the prescription or completion of the vaccination according to the medical specialty of the prescriber [At the end of the study, an average of one month]

    Analysis of the data to identify any significant differences according to the medical specialty of the prescriber.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Internal Medicine Department - NOVO Hospital - Pontoise site Pontoise France 95300

Sponsors and Collaborators

  • Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Dr Christine Trumtel, NOVO Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier:
NCT05788510
Other Study ID Numbers:
  • CHRD 0423
First Posted:
Mar 29, 2023
Last Update Posted:
Mar 29, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier René Dubos
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 29, 2023