Covid-19SCAREAIDNCT04733807
Antibodies Response to mRNA Vaccine Against Covid-19
An observational study of Covid-19, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- BNT162b2 mRNA Covid-19 Vaccine
- Type of treatment
- Vaccines
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jan 2021to 1 Feb 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care, administrative, and technical workers of ICOT-Sapienza University Hospital
Who may be able to join
- Hospital employers vaccinated against Sars-Cov2
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ICOT-Sapienza University Hospital
Latina, LT, 04100
Lugi Iuliano, M.D., +393406462332, luigi.iuliano@uniroma1.it
Alessandro Polidoro, M.D., +393478115718, alessandro.polidoro@uniroma1.it
About this study
Official title: Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects.
Read the detailed description
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers.
The investigators undertake this observational study to monitor antibody evolution after vaccination in a hospital setting. The primary endpoint is serum IgG at the first month of 2nd jab, and at 3, 6, and 12 months afterward.
As secondary measures, nasopharyngeal swabs are included, at fortnight intervals to detects the spike protein antigen, in the event that putative vaccine inefficacy would expose the health personnel to Covid-19 disease with potential spreading to inpatients.
Further, clinical signs and symptoms are monitored at the weekly interval in the context of adverse reactions/events.
- Conditions
- Covid-19
- Being tested
- BNT162b2 mRNA Covid-19 Vaccine
- Keywords
- vaccine, Covid-19, safety, Sars-Cov2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 mRNA Covid-19 VaccineBiological
Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Measured: Serum antibody at 1 month
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Measured: Serum antibody at 3 months
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Measured: Serum antibody at 6 months
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Measured: Serum antibody at 12 months
Secondary outcomes (2)
Sars-Cov2 infection in vaccinated subjects
Monitoring of Sars-Cov2 infection by a nasopharyngeal swab of spike protein Ag, and PCR confirmation in case of Ag swab positivity.
Measured: up to 12 months
Covid-19 disease in vaccinated subjects
Monitoring the occurrence of Covid-19 disease in vaccinated people
Measured: Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start28 Jan 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- ICOT University Hospital
- Responsible party
- Principal investigator, Luigi Iuliano, University of Roma La Sapienza
- Investigators
- Luigi Iuliano, M.D., Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733807
- Sponsor's protocol ID
- SCAREAID
- Acronym
- SCAREAID
- Status last verified
- May 2021
- First submitted
- 28 Jan 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease
- ClinicalTrials.gov ID
- NCT04733807
- Acronym / sponsor ID
- SCAREAID / SCAREAID
- Conditions
- Covid-19
- Keywords
- vaccine, Covid-19, safety, Sars-Cov2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- ICOT University Hospital
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 2 Feb 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.
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers. The investigators undertake this study to monitor IgG evolution after vaccination in the participant hospital settings, which includes 500 subjects.
Detailed description
Vaccine rollout has started in many countries. In Italy, the Covid-19 vaccine used at the moment is the mRNA-based BNT162b2 and is given to Hospital employers.
The investigators undertake this observational study to monitor antibody evolution after vaccination in a hospital setting. The primary endpoint is serum IgG at the first month of 2nd jab, and at 3, 6, and 12 months afterward.
As secondary measures, nasopharyngeal swabs are included, at fortnight intervals to detects the spike protein antigen, in the event that putative vaccine inefficacy would expose the health personnel to Covid-19 disease with potential spreading to inpatients.
Further, clinical signs and symptoms are monitored at the weekly interval in the context of adverse reactions/events.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care, administrative, and technical workers of ICOT-Sapienza University Hospital
Key inclusion criteria (1 listed)
- Hospital employers vaccinated against Sars-Cov2
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT162b2 mRNA Covid-19 VaccineHospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response. | Biological | – |
Primary outcome
Serum IgG antibodies levels in response to vaccine
Time frame: Serum antibody at 1 month
Determination of IgG levels in serum
Serum IgG antibodies levels in response to vaccine
Time frame: Serum antibody at 3 months
Determination of IgG levels in serum
Serum IgG antibodies levels in response to vaccine
Time frame: Serum antibody at 6 months
Determination of IgG levels in serum
Serum IgG antibodies levels in response to vaccine
Time frame: Serum antibody at 12 months
Determination of IgG levels in serum
2 secondary outcomes
Sars-Cov2 infection in vaccinated subjects
Time frame: up to 12 months
Covid-19 disease in vaccinated subjects
Time frame: Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Covid-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Luigi Iuliano, M.D. principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid-19, run by University of Roma La Sapienza at 1 site in Italy.
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 1 inclusion and 1 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Lugi Iuliano, M.D. (+393406462332, luigi.iuliano@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgG antibodies levels in response to vaccine (time frame: Serum antibody at 1 month). The study lists 4 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 11 May 2021.