Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04844632
Study type Observational
Source University of Roma La Sapienza
Contact Stefania Basili, MD
Phone +393393452523
Email stefania.basili@uniroma1.it
Status Recruiting
Phase
Start date February 11, 2021
Completion date May 21, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05596474 - Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue N/A
Recruiting NCT05778578 - Universal Basic Income and Structural Racism in the US South N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT05082935 - COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II N/A
Recruiting NCT05454969 - One-4-ALL Initiative N/A
Enrolling by invitation NCT05045222 - Economic and Clinical Outcomes of (Whole Exome) Sequencing in Tapestry
Completed NCT04587063 - Evaluation of Emails Promoting Mail-order Pharmacy N/A
Recruiting NCT05541913 - The Effect of Tele-Nursing on Parents of Circumcised Children N/A
Completed NCT05117333 - Reminders, Cost Sharing, and Healthcare Use N/A
Recruiting NCT04835012 - Health and Health Care Utilization Effects of Medical Debt Forgiveness
Completed NCT04567342 - Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination N/A
Withdrawn NCT05552638 - Telecare in Rural Senior Centers N/A
Enrolling by invitation NCT04250103 - Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care
Completed NCT04240093 - CoMBAT Opioid Use Disorder: A Combined Medication and Behavioral Activation Treatment for People Living With Opioid Use Disorder N/A
Active, not recruiting NCT03724695 - Advanced Heart Care at Home N/A
Completed NCT04517578 - European Neuromuscular Monitoring Survey
Active, not recruiting NCT05609188 - Black Economic Equity Movement N/A
Completed NCT04373135 - Understanding Community Considerations, Opinions, Values, Impacts, and Decisions for COVID-19 N/A
Recruiting NCT05324566 - Evaluation of ECG Transmission and AI Models Using Apple Watch ECGs and Symptoms Data Collected Using a Mayo iPhone App