Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy

Pneumococcal Vaccine Clinical Trial

— TNF-VAX  

Official title:

Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05788510
• Other study ID #: CHRD 0423
• Status: Completed
• Start date: April 3, 2023
• Est. completion date: May 6, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Vaccine

Intervention

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

Locations

Country	Name	City	State
France	Internal Medicine Department - NOVO Hospital - Pontoise site	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At the end of the study, an average of one month
Secondary	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	Number of patients who received a complete pneumococcal vaccination before initiation of treatment and the number of patients who received it after	At the end of the study, an average of one month
Secondary	Assessment of the number of injections prescribed and/or performed (Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent) for each patient	Number of patients who received an incomplete vaccination scheme (1 dose of Conjugated Pneumococcal Vaccine 13-valent or Unconjugated Pneumococcal Vaccine 23-valent).	At the end of the study, an average of one month
Secondary	Evaluation of the prescription or completion of the vaccination according to the characteristics of the patients and their comorbidities.	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 .....).	At the end of the study, an average of one month
Secondary	Evaluation of the prescription or completion of the vaccination according to the medical specialty of the prescriber	Analysis of the data to identify any significant differences according to the medical specialty of the prescriber.	At the end of the study, an average of one month

External Links

•   COVARISQ (estimation de la COuverture VAccinale des adultes à RISQues) : taux de vaccination des immunodéprimés en France en 2017
•   Haut Conseil de Santé Public - Vaccination des personnes immunodéprimées ou aspléniques - Recommandations - Rapport 2012