Clinical trial NCT04702295: ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)
Official title: COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Connective Tissue Diseases
Rare Diseases
Rheumatologic Disorder
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult (\>18 years) patients with a diagnosis of rCTDs who will be given the vaccine during the period from January 2021 and January 2022.

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events (any type)
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of disease flare post-vaccination
timeFrame: 12 months
measure: Incidence of serious adverse events
timeFrame: 12 months
measure: Incidence of life-threatening adverse events and deaths
timeFrame: 12 months
measure: Incidence of adverse events of special interest for COVID-19
timeFrame: 12 months
measure: Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up
timeFrame: 12 months
measure: Comparison of the incidence of COVID-19 among different types of vaccines
timeFrame: 12 months
measure: Significant anti COVID 19 antibodies titer at 3 and 6 months
timeFrame: 3 and 6 months
Other outcomes:
Locations:
Study officials:
References: