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

Civil Hospices of Lyon

Status

Completed

Conditions

COVID-19

Treatments

Diagnostic Test: COVID-19 vaccinated people

Study type

Interventional

Funder types

Other

Identifiers

NCT05060939

69HCL21_0748

Details and patient eligibility

About

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.

Enrollment

1,072 patients

Sex

All

Ages

18 to 95 years old

Volunteers

No 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