Connective Tissue DiseasesVACCINATENCT04702295
ERN ReCONNET Study on COVID-19 Vaccination in Rare and Complex Connective Tissue Disease (VACCINATE)
An observational study of Connective Tissue Diseases and Rare Diseases, run by University of Pisa.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Connective Tissue Diseases, Rare Diseases, Rheumatologic Disorder
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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),
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- relapsing polychondritis (RP),
- Sjogren's syndrome (SS),
- systemic lupus erythematosus (SLE),
- systemic sclerosis (SSc)
- undifferentiated connective tissue disease (UCTD)
Who cannot join
- Pregnancy
- All the exclusion criteria that apply for COVID-19 vaccination in the general population
About this study
Official title: 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)
Read the 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
- Medical subject headings
- Connective Tissue Diseases, Rare Diseases, Collagen Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (any type)
Measured: 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
Measured: 12 months
Secondary outcomes (7)
Incidence of disease flare post-vaccination
Measured: 12 months
Incidence of serious adverse events
Measured: 12 months
Incidence of life-threatening adverse events and deaths
Measured: 12 months
Incidence of adverse events of special interest for COVID-19
Measured: 12 months
Clinical variables (age, sex, underlying disease, ongoing treatment, comorbidities) associated with COVID-19 occurrence during the post-vaccination follow-up
Measured: 12 months
Comparison of the incidence of COVID-19 among different types of vaccines
Measured: 12 months
Significant anti COVID 19 antibodies titer at 3 and 6 months
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Mosca, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702295
- Sponsor's protocol ID
- UPISA2
- Acronym
- VACCINATE
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID Vaccination in Rare and Complex Connective Tissue Diseases: ERN ReCONNET Multicentre Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04702295
- Acronym / sponsor ID
- VACCINATE / UPISA2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- antiphospholipid syndrome (APS),
- Ehlers-Danlos syndrome (EDS),
- idiopathic inflammatory myopathies (IIM),
- IgG4-related disease (IgG4),
- mixed connective tissue disease (MCTD),
Key exclusion criteria (2 listed)
- Pregnancy
- All the exclusion criteria that apply for COVID-19 vaccination in the general population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Connective Tissue Diseases and Rare Diseases, run by University of Pisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (any type) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.