SAPIENZAVAX: COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

• Sponsor: University of Roma La Sapienza (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04844632
• Collaborator: Istituto Superiore di Sanità (Other)
• Enrollment: 5,000
• Location: 1
• Anticipated Duration (Months): 15.2
• Patients Per Site Per Month: 328

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Care Utilization; Health Care Associated Infection	Biological: Vaccine anti-Covid19

Study Design

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
• Actual Study Start Date: Feb 11, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: May 21, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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;

4. 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

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Policlinico Umberto I	Roma		Italy	00161

Sponsors and Collaborators

• University of Roma La Sapienza
• Istituto Superiore di Sanità

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefania Basili, Full Professor, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT04844632
• Other Study ID Numbers: COVID19 vaccination_Sapienza
• First Posted: Apr 14, 2021
• Last Update Posted: Apr 14, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stefania Basili, Full Professor, University of Roma La Sapienza: Covid19; Vaccine
• Additional relevant MeSH terms: COVID-19; Cross Infection

Study Results

No Results Posted as of Apr 14, 2021