ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)

Rare Diseases Clinical Trial

— VACCINATE  

Official title:

COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04702295
• Other study ID #: UPISA2
• Status: Not yet recruiting
• Start date: February 2021
• Est. completion date: August 2023

Study information

• Verified date: January 2021
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

30 months, multicentre, prospective observational study on adult (>18 years) patients with a diagnosis of rare and complex connective tissue diseases (rCTDs) who will be given the vaccine during the period from January 2021 and January 2022.

Patients with the following diagnosis will be included:

• antiphospholipid syndrome (APS),

• Ehlers-Danlos syndrome (EDS),

• idiopathic inflammatory myopathies (IIM),

• IgG4-related disease (IgG4),

• mixed connective tissue disease (MCTD),

• relapsing polychondritis (RP),

• Sjogren's syndrome (SS),

• systemic lupus erythematosus (SLE),

• systemic sclerosis (SSc)

• undifferentiated connective tissue disease (UCTD)

Description:

This is an observational study aimed at gathering sufficient number of cases of rCTDs patients who will receive COVID-19 vaccination that will help in better understanding of both safety and efficacy of the vaccine in this population. The study will be promoted both in ERN ReCONNET Full Members and Affiliated Partners as well as in other centres treating and managing rare and complex connective tissue diseases.

Study Objectives

1. To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;

2. To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;

3. To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;

4. To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients

5. To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Patients with the following diagnosis will be included:

• antiphospholipid syndrome (APS),

• Ehlers-Danlos syndrome (EDS),

• idiopathic inflammatory myopathies (IIM),

• IgG4-related disease (IgG4),

• mixed connective tissue disease (MCTD),

• relapsing polychondritis (RP),

• Sjogren's syndrome (SS),

• systemic lupus erythematosus (SLE),

• systemic sclerosis (SSc)

• undifferentiated connective tissue disease (UCTD)

Exclusion Criteria:

• Pregnancy

• All the exclusion criteria that apply for COVID-19 vaccination in the general population

Related Conditions & MeSH terms

• Collagen Diseases
• Connective Tissue Diseases
• Rare Diseases
• Rheumatic Diseases
• Rheumatologic Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (any type)		12 months
Primary	COVID-19 incidence in patients with and without evidence of past SARS-CoV-2 infection before and during vaccination regimen - cases confirmed =7 days after the last dose		12 months
Secondary	Incidence of disease flare post-vaccination		12 months
Secondary	Incidence of serious adverse events		12 months
Secondary	Incidence of life-threatening adverse events and deaths		12 months
Secondary	Incidence of adverse events of special interest for COVID-19		12 months
Secondary	Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up		12 months
Secondary	Comparison of the incidence of COVID-19 among different types of vaccines		12 months
Secondary	Significant anti COVID 19 antibodies titer at 3 and 6 months		3 and 6 months