BAL Antonin
Lyon, National Reference Center For Respiratory Viruses, 69317 LYON Cedex 04, France
NCT Number: NCT05060939
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.
Looking for future studies?
Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Lyon, National Reference Center For Respiratory Viruses, 69317 LYON Cedex 04, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At inclusion
Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples
Time frame: At inclusion
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
Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France.
Time frame: At inclusion
Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic
Hospices Civils de Lyon
Other
Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection
Acronym: COVID-IVAC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT07722000
COVID-19, Chronic Disease
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT04371432
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial Details