Health Care UtilizationSAPIENZAVAXNCT04844632
COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
An observational study of Health Care Utilization and Health Care Associated Infection, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Primary objective: 1. Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization, Health Care Associated Infection
- What is being tested?
- Vaccine anti-Covid19
- Type of treatment
- Vaccines
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 11 Feb 2021to 21 May 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects (age> 18) booked for anti-SARS-CoV-2 vaccination at the AOU Policlinico Umberto I. Subjects will include healthcare personnel, medical students and university staff recruited from Sapienza University of Rome and Umberto I university hospital.
Who may be able to join
- All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.
Who cannot join
- All subjects who refuse to give consent or who have contraindications to vaccination.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU Policlinico Umberto I
Roma, 00161
Stefania Basili, MD, stefania.basili@uniroma1.it
About this study
Primary objective:
- Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
Read more
Secondary objectives:
- Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
- Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
- Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;
- Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus;
- To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Methodology:
- Administration at baseline of a questionnaire for the collection of clinical data.
- Perform a blood sample to measure antibody response in vaccinated subjects
- Administer a questionnaire to evaluate adverse events after vaccination
- Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
- An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
- In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
- In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.
- Being tested
- Vaccine anti-Covid19
- Keywords
- Covid19, Vaccine
- Medical subject headings
- Patient Acceptance of Health Care, Cross Infection, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine anti-Covid19Biological
Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Following Immunization - AEFI
Adverse events (Adverse Event Following Immunization - AEFI) monitoring in vaccinated subjects and analyze associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
Measured: 12 months from immunization
Secondary outcomes (5)
Antibody response in vaccinated subject
To monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
Measured: 1, 3, 6, 12 months from immunization
Anti-Spike immune response
Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
Measured: 1, 3, 6, 12 months from immunization
Anti- Nucleoprotein (N) induced by natural infection evaluation
To assess the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;
Measured: 1, 3, 6, 12 months from immunization
Neutralizing capacity of sera
to evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus
Measured: 1, 3, 6, 12 months from immunization
Cell-mediated immune response
To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Measured: Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start11 Feb 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion21 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Responsible party
- Principal investigator, Stefania Basili, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844632
- Sponsor's protocol ID
- COVID19 vaccination_Sapienza
- Acronym
- SAPIENZAVAX
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Capozzi A, Riitano G, Recalchi S, Manganelli V, Longo A, Falcou A, De Michele M, Garofalo T, Pulcinelli FM, Sorice M, Misasi R. Antiphospholipid antibodies in patients with stroke during COVID-19: A role in the signaling pathway leading to platelet activation. Front Immunol. 2023 Mar 2;14:1129201. doi: 10.3389/fimmu.2023.1129201. eCollection 2023.
PubMed 36936925
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
- ClinicalTrials.gov ID
- NCT04844632
- Acronym / sponsor ID
- SAPIENZAVAX / COVID19 vaccination_Sapienza
- Keywords
- Covid19, Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Istituto Superiore di Sanità
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 21 May 2022 (estimated)
- First posted
- 14 Apr 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.
Primary objective:
- Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
Secondary objectives:
- Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
- Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
- Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection;
- Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus;
- To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Methodology:
- Administration at baseline of a questionnaire for the collection of clinical data.
- Perform a blood sample to measure antibody response in vaccinated subjects
- Administer a questionnaire to evaluate adverse events after vaccination
- Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
- An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
- In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
- In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects (age> 18) booked for anti-SARS-CoV-2 vaccination at the AOU Policlinico Umberto I. Subjects will include healthcare personnel, medical students and university staff recruited from Sapienza University of Rome and Umberto I university hospital.
Key inclusion criteria (1 listed)
- All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.
Key exclusion criteria (1 listed)
- All subjects who refuse to give consent or who have contraindications to vaccination.
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 |
|---|---|---|
| Vaccine anti-Covid19Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine | Biological | – |
Primary outcome
Adverse Event Following Immunization - AEFI
Time frame: 12 months from immunization
Adverse events (Adverse Event Following Immunization - AEFI) monitoring in vaccinated subjects and analyze associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.
5 secondary outcomes
Antibody response in vaccinated subject
Time frame: 1, 3, 6, 12 months from immunization
Anti-Spike immune response
Time frame: 1, 3, 6, 12 months from immunization
Anti- Nucleoprotein (N) induced by natural infection evaluation
Time frame: 1, 3, 6, 12 months from immunization
Neutralizing capacity of sera
Time frame: 1, 3, 6, 12 months from immunization
Cell-mediated immune response
Time frame: Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 36936925Capozzi A, Riitano G, Recalchi S, Manganelli V, Longo A, Falcou A, De Michele M, Garofalo T, Pulcinelli FM, Sorice M, Misasi R. Antiphospholipid antibodies in patients with stroke during COVID-19: A role in the signaling pathway leading to platelet activation. Front Immunol. 2023 Mar 2;14:1129201. doi: 10.3389/fimmu.2023.1129201. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Health Care Utilization and Health Care Associated Infection, 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 14 Apr 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 Stefania Basili, MD (+393393452523, stefania.basili@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Following Immunization - AEFI (time frame: 12 months from immunization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844632, which also lists 1 linked publication.
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 14 Apr 2021.