search
Back to results

SARS-CoV-2 Infection in COVID-19 Vaccinated Patients (COVID-IVAC)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
COVID-19 vaccinated people
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2, COVID-19, vaccine,, variant, host-immune response

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: ≥ 18 years old
  • Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months.
  • Persons affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

- Pregnant or lactating woman

Sites / Locations

  • BAL AntoninRecruiting

Outcomes

Primary Outcome Measures

Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients
Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples

Secondary Outcome Measures

Titers of SARS-CoV-2 antibodies
Measurement of anti-N, anti-S antibody titers with commercial serological tests. Measurement of neutralizing antibody titers with virus neutralization assay
Titers of SARS-CoV-2 antibodies
Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France.
Titers of SARS-CoV-2 antibodies
Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic

Full Information

First Posted
September 28, 2021
Last Updated
July 21, 2022
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT05060939
Brief Title
SARS-CoV-2 Infection in COVID-19 Vaccinated Patients
Acronym
COVID-IVAC
Official Title
Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Vaccination of the population is crucial in the fight against the COVID-19 pandemic. Although most available vaccines have an estimated efficacy against symptomatic infection of 65-95%, this can be significantly reduced if the patient has co-morbidities such as immunosuppression or if the full vaccination schedule is not followed. Infection with SARS-CoV-2 variants, carrying mutations, notably on the spike protein, may also be associated with escape from immunity acquired by vaccination. Indeed, in vitro studies have shown a decrease in sensitivity to neutralizing antibodies acquired after vaccination or even after infection for certain variants such as variant B.1.351 (beta variant according to the WHO, first detection in South Africa) or variant B.1.617.2. (delta variant according to the WHO, first detection in India). On the other hand, cases of COVID-19 following a full vaccination regimen have recently been reported. With the increasing detection of new variants and in the context of increasing vaccination coverage of the population, one of the priority missions of the National Reference Centre (NRC) for respiratory infection viruses is to clinically and virologically investigate all cases of infection in vaccinated patients. The main objective is to determine whether a particular variant is over-represented in vaccinated patients with an infection. The secondary objective is to study the humoral immune response in COVID-19 vaccinated patients with and without SARS-CoV-2 infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, COVID-19, vaccine,, variant, host-immune response

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
COVID-19 vaccinated people
Intervention Description
Patients with at least one dose of COVID-19 vaccine tested for SARS-CoV-2 infection with RT-PCR on respiratory specimen. RT-PCR, serological testing and viral sequencing will be applied on patient's samples
Primary Outcome Measure Information:
Title
Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients
Description
Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Titers of SARS-CoV-2 antibodies
Description
Measurement of anti-N, anti-S antibody titers with commercial serological tests. Measurement of neutralizing antibody titers with virus neutralization assay
Time Frame
At inclusion
Title
Titers of SARS-CoV-2 antibodies
Description
Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France.
Time Frame
At inclusion
Title
Titers of SARS-CoV-2 antibodies
Description
Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: ≥ 18 years old Persons having given their written consent and accepting a follow-up every 6 months for 24 months, followed by a final visit at 36 months. Persons affiliated to a social security scheme or beneficiary of such a scheme Exclusion Criteria: - Pregnant or lactating woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BAL Antonin, Dr
Phone
04 72 07 16 98
Email
antonin.bal@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
JOSSET Laurence, Dr
Phone
04 72 07 10 22
Email
laurence.josset@chu-lyon.fr
Facility Information:
Facility Name
BAL Antonin
City
Lyon
State/Province
National Reference Center For Respiratory Viruses
ZIP/Postal Code
69317 LYON Cedex 04
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BAL Antonin, Dr
Phone
04 72 07 16 98
Email
antonin.bal@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

SARS-CoV-2 Infection in COVID-19 Vaccinated Patients

We'll reach out to this number within 24 hrs