COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

Health Care Utilization Clinical Trial

— SAPIENZAVAX  

Official title:

COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04844632
• Other study ID #: COVID19 vaccination_Sapienza
• Status: Recruiting
• Start date: February 11, 2021
• Est. completion date: May 21, 2022

Study information

• Verified date: April 2021
• Source: University of Roma La Sapienza
• Contact: Stefania Basili, MD
• Phone: +393393452523
• Email: stefania.basili[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: May 21, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cross Infection
• Health Care Associated Infection
• Health Care Utilization

Intervention

Biological:
• Vaccine anti-Covid19
Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine

Locations

Country	Name	City	State
Italy	AOU Policlinico Umberto I	Roma

Sponsors (2)

Lead Sponsor	Collaborator
University of Roma La Sapienza	Istituto Superiore di Sanità

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months from immunization
Secondary	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.	1, 3, 6, 12 months from immunization
Secondary	Anti-Spike immune response	Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.	1, 3, 6, 12 months from immunization
Secondary	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;	1, 3, 6, 12 months from immunization
Secondary	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	1, 3, 6, 12 months from immunization
Secondary	Cell-mediated immune response	To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.	Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization