COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

• Conditions: Health Care Utilization; Health Care Associated Infection

• Registration Number: NCT04844632
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-11
• Status Verified: 2021-04
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-14
• Last Update Posted: 2021-04-14
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.

Exclusion Criteria

All subjects who refuse to give consent or who have contraindications to vaccination.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event Following Immunization - AEFI	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.

Secondary Outcome Measures

Name	Time	Method
Neutralizing capacity of sera	1, 3, 6, 12 months from immunization	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
Anti- Nucleoprotein (N) induced by natural infection evaluation	1, 3, 6, 12 months from immunization	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;
Antibody response in vaccinated subject	1, 3, 6, 12 months from immunization	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.
Cell-mediated immune response	Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization	To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Anti-Spike immune response	1, 3, 6, 12 months from immunization	Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.

Trial Locations

Locations (1)

AOU Policlinico Umberto I; 🇮🇹 Roma, Italy