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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05060939
Acronym
COVID-IVAC
Enrollment
1072
Registered
2021-09-29
Start date
2021-08-20
Completion date
2024-02-20
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

SARS-CoV-2, COVID-19, vaccine,, variant, host-immune response

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.

Interventions

DIAGNOSTIC_TESTCOVID-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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patientsAt inclusionWhole genome sequencing of SARS-CoV-2 RT-PCR positive samples

Secondary

MeasureTime frameDescription
Titers of SARS-CoV-2 antibodiesAt inclusionMeasurement of anti-N, anti-S antibody titers with commercial serological tests. Measurement of neutralizing antibody titers with virus neutralization assay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026