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

Study Overview
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Brief Summary
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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.

Official Title
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Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: COVID-19 vaccinated people


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: COVID-19 vaccinated people|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients | Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At inclusion | 
| Titers of SARS-CoV-2 antibodies | Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France. | At inclusion | 
| Titers of SARS-CoV-2 antibodies | Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic | At inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19, vaccine,, variant, host-immune response