Antibodies Response to mRNA Vaccine Against Covid-19
SCAREAID
Sars-Cov2 Antibodies Response to vaccinE Against covId-19 Disease
1 other identifier
observational
600
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2021
CompletedStudy Start
First participant enrolled
January 28, 2021
CompletedFirst Posted
Study publicly available on registry
February 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMay 11, 2021
May 1, 2021
6 months
January 28, 2021
May 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Serum antibody at 1 month
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Serum antibody at 3 months
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Serum antibody at 6 months
Serum IgG antibodies levels in response to vaccine
Determination of IgG levels in serum
Serum antibody at 12 months
Secondary Outcomes (2)
Sars-Cov2 infection in vaccinated subjects
up to 12 months
Covid-19 disease in vaccinated subjects
Clinical monitoring of vaccinated subjects through the study completion, an average of 1 year.
Interventions
Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.
Eligibility Criteria
Health care, administrative, and technical workers of ICOT-Sapienza University Hospital
You may qualify if:
- Hospital employers vaccinated against Sars-Cov2
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Roma La Sapienzalead
- ICOT University Hospitalcollaborator
Study Sites (1)
ICOT-Sapienza University Hospital
Latina, LT, 04100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luigi Iuliano, M.D.
University of Roma La Sapienza
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
January 28, 2021
First Posted
February 2, 2021
Study Start
January 28, 2021
Primary Completion
July 31, 2021
Study Completion
February 1, 2022
Last Updated
May 11, 2021
Record last verified: 2021-05