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

NCT ID: NCT05060939

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1072 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2024-02-20

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.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BAL Antonin

Lyon, National Reference Center For Respiratory Viruses, France

Countries

France

References

Roy A, Saade C, Josset L, Clement B, Morfin F, Destras G, Valette M, Icard V, Billaud G, Oblette A, Debombourg M, Garrigou C, Brengel-Pesce K, Generenaz L, Saker K, Hernu R, Pozzetto B, Lina B, Trabaud MA, Trouillet-Assant S, Bal A. Determinants of protection against SARS-CoV-2 Omicron BA.1 and Delta infections in fully vaccinated outpatients. J Med Virol. 2023 Aug;95(8):e28984. doi: 10.1002/jmv.28984.

Reference Type: BACKGROUND

PMID: 37503561 (View on PubMed)

Other Identifiers

69HCL21_0748

Identifier Type: -

Identifier Source: org_study_id