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OpenTrials
Completed

NCT Number: NCT05060939

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

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BAL Antonin

Lyon, National Reference Center For Respiratory Viruses, 69317 LYON Cedex 04, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 vaccinated people

Diagnostic Test

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 outcomes

  1. Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients

    Time frame: At inclusion

    Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples

Secondary outcomes

  1. Titers of SARS-CoV-2 antibodies

    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

  2. Titers of SARS-CoV-2 antibodies

    Time frame: At inclusion

    Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France.

  3. Titers of SARS-CoV-2 antibodies

    Time frame: At inclusion

    Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COVID-IVAC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2021
Registry last updated
Sep 3, 2025

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.

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