ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE) (VACCINATE)
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| ClinicalTrials.gov Identifier: NCT04702295 |
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Recruitment Status :
Not yet recruiting
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
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Sponsor:
University of Pisa
Information provided by (Responsible Party):
Marta Mosca, University of Pisa
- Study Details
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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)
| Condition or disease |
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| Connective Tissue Diseases Rare Diseases Rheumatologic Disorder |
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 : | Observational |
| Estimated Enrollment : | 250 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study |
| Estimated Study Start Date : | February 2021 |
| Estimated Primary Completion Date : | February 2023 |
| Estimated Study Completion Date : | August 2023 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Incidence of adverse events (any type) [ Time Frame: 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 ]
Secondary Outcome Measures :
- Incidence of disease flare post-vaccination [ Time Frame: 12 months ]
- Incidence of serious adverse events [ Time Frame: 12 months ]
- Incidence of life-threatening adverse events and deaths [ Time Frame: 12 months ]
- Incidence of adverse events of special interest for COVID-19 [ Time Frame: 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 ]
- Comparison of the incidence of COVID-19 among different types of vaccines [ Time Frame: 12 months ]
- Significant anti COVID 19 antibodies titer at 3 and 6 months [ Time Frame: 3 and 6 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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
No Contacts or Locations Provided
| Responsible Party: | Marta Mosca, Full Professor in Rheumatology, University of Pisa |
| ClinicalTrials.gov Identifier: | NCT04702295 |
| Other Study ID Numbers: |
UPISA2 |
| First Posted: | January 8, 2021 Key Record Dates |
| Last Update Posted: | January 8, 2021 |
| Last Verified: | January 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Rheumatic Diseases Connective Tissue Diseases Collagen Diseases Rare Diseases |
Disease Attributes Pathologic Processes Musculoskeletal Diseases |