COVID-19COVID-IVACNCT05060939
SARS-CoV-2 Infection in COVID-19 Vaccinated Patients
A study testing COVID-19 vaccinated people in people with COVID-19, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
France1 site
BAL Antonin
Lyon, National Reference Center For Respiratory Viruses, 69317 LYON Cedex 04
About this study
Official title: Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection
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
- Being tested
- COVID-19 vaccinated people
- Keywords
- SARS-CoV-2, COVID-19, vaccine,, variant, host-immune response
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinated peopleDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients
Whole genome sequencing of SARS-CoV-2 RT-PCR positive samples
Measured: At inclusion
Secondary outcomes (3)
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
Measured: At inclusion
Titers of SARS-CoV-2 antibodies
Neutralizing antibody titer measurements for different variants including graded variants of concern by Public Health France.
Measured: At inclusion
Titers of SARS-CoV-2 antibodies
Measurement of interferon gamma titer by an ELISA method after stimulation with a peptide immunogenic
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start20 Aug 2021
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,072 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060939
- Sponsor's protocol ID
- 69HCL21_0748
- Acronym
- COVID-IVAC
- Status last verified
- Aug 2025
- First submitted
- 28 Sep 2021
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37503561
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Viral Genome and Humoral Immune Response in COVID-19 Vaccinated Patients With SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT05060939
- Acronym / sponsor ID
- COVID-IVAC / 69HCL21_0748
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, COVID-19, vaccine,, variant, host-immune response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,072 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or lactating woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccinated peoplePatients 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 | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
Titers of SARS-CoV-2 antibodies
Time frame: At inclusion
Titers of SARS-CoV-2 antibodies
Time frame: At inclusion
Titers of SARS-CoV-2 antibodies
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 37503561Roy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COVID-19 vaccinated people in people with COVID-19, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of the clade and lineage of SARS-CoV-2 in vaccinated patients (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.