- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702295
ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE) (VACCINATE)
COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study
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)
Study Overview
Status
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
- To promote a harmonised data collection approach on COVID-19 vaccination in rare and complex CTDs patients;
- To evaluate the safety profile of COVID-19 vaccination in rCTDs patients and to highlight possible disease-specific adverse events;
- To evaluate the efficacy of COVID-19 vaccination in rCTDs patients and to highlight potential variables that prevent an effective immunization against COVID-19;
- To evaluate differences in term of efficacy and safety among different types of vaccines in rCTDs patients
- To depict the ideal patient's profile that would mostly benefit from COVID-19 vaccination
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (any type)
Time Frame: 12 months
|
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
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of disease flare post-vaccination
Time Frame: 12 months
|
12 months
|
Incidence of serious adverse events
Time Frame: 12 months
|
12 months
|
Incidence of life-threatening adverse events and deaths
Time Frame: 12 months
|
12 months
|
Incidence of adverse events of special interest for COVID-19
Time Frame: 12 months
|
12 months
|
Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up
Time Frame: 12 months
|
12 months
|
Comparison of the incidence of COVID-19 among different types of vaccines
Time Frame: 12 months
|
12 months
|
Significant anti COVID 19 antibodies titer at 3 and 6 months
Time Frame: 3 and 6 months
|
3 and 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPISA2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Connective Tissue Diseases
-
Hospital for Special Surgery, New YorkRecruitingUndifferentiated Connective Tissue DiseaseUnited States
-
The University of Hong KongCompleted
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
Poitiers University HospitalTerminated
-
Eunice Kennedy Shriver National Institute of Child...HRA PharmaCompletedLeiomyomaUnited States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
AbbottCompleted
-
AbbottCompleted
-
Sunnybrook Health Sciences CentreSunnybrook Research Institute; Arrayus Technologies Inc.Active, not recruiting