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

COVID-19 Clinical Trial

— COVID-IVAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05060939
• Other study ID #: 69HCL21_0748
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1072
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
France	BAL Antonin	Lyon	National Reference Center For Respiratory Viruses

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Titers of SARS-CoV-2 antibodies	Measurement of anti-N, anti-S antibody titers with commercial serological tests.; Measurement of neutralizing antibody titers with virus neutralization assay	At inclusion
Secondary	Titers of SARS-CoV-2 antibodies	Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France.	At inclusion
Secondary	Titers of SARS-CoV-2 antibodies	Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic	At inclusion