Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-02 @ 10:19 AM
Study NCT ID:
NCT04844632
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2021-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
Sponsor:
University of Roma La Sapienza
Organization:
Study Overview
Official Title:
COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAPIENZAVAX
Brief 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. 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.
2. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
3. 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;
4. 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;
5. To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Methodology:
1. Administration at baseline of a questionnaire for the collection of clinical data.
2. Perform a blood sample to measure antibody response in vaccinated subjects
3. Administer a questionnaire to evaluate adverse events after vaccination
4. Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
5. An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
6. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
7. 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.
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. 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.
2. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
3. 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;
4. 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;
5. To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Methodology:
1. Administration at baseline of a questionnaire for the collection of clinical data.
2. Perform a blood sample to measure antibody response in vaccinated subjects
3. Administer a questionnaire to evaluate adverse events after vaccination
4. Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
5. An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
6. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
7. 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: