Immunity After COVID-19 Vaccination (IACOVV)

Estimation of Dynamics of Humoral Immunity in COVID-19 Vaccined Health Care Workers

The purpose of the research is to evaluate kinetic after vaccination to the COVID-19 coronavirus by measurements of specific and neutralizant antibodies for spike antigenic sequences .

This work will allow us to follow the efficacy and tolerance of the vaccine over a year, to evaluate the antibody profile, their kinetics, the fraction of neutralising antibodies and will also allow us to understand the attitudes to be taken to ensure the best protection for our staff

Study Overview

• Status: Recruiting
• Conditions: Tunis Military Hospital Staff Vaccinated Against Covid 19
• Intervention / Treatment: Other: Blood sampling (4 per year)

Detailed Description

Our objective is to follow the hospital staff after vaccination, for this we will include two groups of participants:

G1: vaccinated staff who did not contract the virus (at the date of vaccination) and who had a serology <0 at least at D7 of the date of vaccination dose 1 (known serological value) G2: vaccinated personnel who have contracted the virus with a PCR + and who have positive serology at least at D7 of the date of vaccination (known serological value)

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Tunisia
  • Please Select...
    • Tunis, Please Select..., Tunisia, 1008
      • Recruiting
      • HMPIT vaccination committee
      • Contact: Nejla stambouli; Phone Number: 55104235; Email: nejlastam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

military health personnel vaccinated at tunis military hospital

Description

Inclusion Criteria:

RB-approved informed consent, age 18 years or older, male or female, anyone considering COVID-19 vaccination or anyone that has received COVID-19 vaccination.

Subjects can enroll at anytime after vaccination even though they may not have enrolled before vaccination.

Sampling Frequency and timing: Up to 8 total samples in 12 months -

Exclusion Criteria:

Exclusion: Failure to provide informed consent

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine effectiveness	Vaccine effectiveness as measured by the number of positive PCRs in one year	1 year
Vaccine effectiveness	antibody kinetics	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the tolerance of the vaccine	post-vaccination adverse event	1 year

Collaborators and Investigators

• Sponsor: General Administration of Military Health, Tunisia

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UR17DN05-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No