Vaccination in Inflammatory Rheumatic Disease (VACCIMIL). The Impact of Antirheumatic Treatment on Antibody Response

Scleroderma Clinical Trial

— Vaccimil  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240888
• Other study ID #: 2011/341
• Secondary ID: Vaccimil
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall objective of this project is to study the influence of modern anti-inflammatory treatments in established inflammatory rheumatic diseases (IRD) on immune response elicited by pneumococcal vaccination using 13-valent conjugate vaccine and influenza vaccination. In addition, the aim is to study the clinical aspects of vaccination regarding: tolerability in immunosuppressed patients with IRD, impact on existing rheumatic disease, possible association with onset of new autoimmune diseases, long-term immunity following pneumococcal vaccination, efficacy in preventing invasive pneumococcal diseases and influenza related serious infections. Results from this study are expected to bridge the existing knowledge gap and contribute to body of evidence needed for recommendations and implementation of vaccination program in IRD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with IRD receiving active anti-rheumatic treatments with DMARDs or biological remedies are offered to participate in the study. The protocol permits stratification for prednisolone usage, smoking habits and alcohol consumption.

Exclusion Criteria:

• age <18 years;

• pregnancy,

• known intolerance of vaccine,

• ongoing infection

Related Conditions & MeSH terms

• RA
• Scleroderma
• Sjögrens
• SLE
• Syndrome
• Vasculitis

Intervention

Biological:
• 0,5 mg Prevenar i.m.

• 0,5 mg seasonal influenza vaccine i.m.

Locations

Country	Name	City	State
Sweden	Skåne University hospital, Dept of rheumatology	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The occurence of severe pneumococcal infections in immunized patients	Analysis of the occurence of severe pneumococcal infections in immunized patients compared to matched not-immunized controls	within 5 years after pneumococcal vaccination
Primary	antibody response following vaccination	measurement of antibody levels against different pneumococcal capsular serotypes and 3 influenza virus strains	4-6 weeks after pneumococcal and influenza vaccination
Secondary	long-term immunity following pneumococcal vaccination	measurement of antibody levels against different pneumococcal capsular serotypes	3 years after pneumococcal vaccination
Secondary	long-term immunity after vaccination with pneumococcal conjugate vaccine	measurement of antibody levels against different pneumococcal polysaccharide serotypes	5 years after vaccination