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

NCT05060939 | Completed

• 1 other identifier: 69HCL21_0748
• Study Type: interventional
• Target: 1,072
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

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

  At inclusion

Secondary Outcomes (3)

• Titers of SARS-CoV-2 antibodies

  At inclusion

• Titers of SARS-CoV-2 antibodies

  At inclusion

• Titers of SARS-CoV-2 antibodies

  At inclusion

Interventions

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Pregnant or lactating woman

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

BAL Antonin

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

Location

Related Publications (1)

• 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.

  PMID: 37503561 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: September 29, 2021
• Study Start: August 20, 2021
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)