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

• Conditions: Rheumatologic Disorder; Rare Diseases; Connective Tissue Diseases

• Registration Number: NCT04702295
• Lead Sponsor: University of Pisa

Brief 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)

Detailed 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

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Study Start: 2021-02
• Primary Completion: 2023-02
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (any type)	12 months
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 Outcome Measures

Name	Time	Method
Incidence of life-threatening adverse events and deaths	12 months
Incidence of adverse events of special interest for COVID-19	12 months
Comparison of the incidence of COVID-19 among different types of vaccines	12 months
Significant anti COVID 19 antibodies titer at 3 and 6 months	3 and 6 months
Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up	12 months
Incidence of disease flare post-vaccination	12 months
Incidence of serious adverse events	12 months