SARS CoV 2 InfectionNCT05338736
Humoral and Cellular Immunity in First-cycle SARS-CoV-2 Vaccinated COVID-19 Patients
An observational study of SARS CoV 2 Infection and COVID-19, run by University Magna Graecia at 1 site in Italy.
Trial summary
Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by "flu-like" symptoms up to severe acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS CoV 2 Infection, COVID-19
- What is being tested?
- LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin), LIAISON SARS-CoV2-IgM (DiaSorin) and Human IFN-g ELISpot PLUS (ALP) (AUROGENE)
- Type of treatment
- Vaccines
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 27 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Forty-five patients will be totally enrolled in the study. Three cohorts of patients will be considered. 1. Control group: 15 vaccinated patients with a pharyngeal swab negative for SARS-CoV-2 isolation 2. Asymptomatic group: 15 vaccinated patients with a pharyngeal swab positive for SARS-CoV-2 isolation and absence of symptoms related to the infection 3. Symptomatic group: 15 vaccinated patients with a pharyngeal swab positive for SARS-CoV-2 isolation and presence of moderate to severe symptoms related to the infection (i.e. peripheral oxygen saturation lower than 94% in room air)
Who may be able to join
- Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before.
Who cannot join
- Presence of malignancy under chemotherapy
- Patient with previous transplantation
- Patient receiving immuno-modulatory or immunosuppressive drugs
- Patient receiving corticosteroid therapy since more than 10 days
- Pregnancy
- Consent withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Humoral and Cellular Immunity in First-cycle Vaccinated Patients Infected by SARS-COV-2: an Observational Study
Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by "flu-like" symptoms up to severe acute respiratory failure. The pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. To date, despite the extensive scientific research aimed at curing COVID-19, there are few effective means to tackle SARS-CoV-2 infection and reduce its disease progression. Among these, a first complete anti-SARS-CoV-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. On the other hand, over time the antibody response induced by vaccines against SARS-CoV-2 decreases, so much so as to indicate the need for a third booster dose. This translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. On the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for SARS-CoV-2. The investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. For these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in SARS-CoV-2 positive first complete vaccination patients.
- Conditions
- SARS CoV 2 Infection, COVID-19
- Being tested
- LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin), LIAISON SARS-CoV2-IgM (DiaSorin), Human IFN-g ELISpot PLUS (ALP) (AUROGENE)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)Diagnostic test
Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients
LIAISON SARS-CoV2-IgM (DiaSorin)Diagnostic test
Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients
Human IFN-g ELISpot PLUS (ALP) (AUROGENE)Diagnostic test
Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Control patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, and with a nasopharyngeal swab negative for SARS-CoV-2 isolation. Receives: Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin); Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin); Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE) | |
| Asymptomatic group | Patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, with a nasopharyngeal swab positive for SARS-CoV-2 isolation, in absence of any symptoms of COVID-19 Receives: Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin); Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin); Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE) | |
| Symptomatic group | Patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, with a nasopharyngeal swab positive for SARS-CoV-2 isolation, with moderate to severe symptoms of COVID-19 Receives: Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin); Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin); Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins
After obtaining plasma of included patients, the plasma will be processed with a dedicated kit to measure the concentration of Immunoglobulin G and M. Differences between patients' cohorts will be assessed
Measured: At day 0
Differences between populations with respect to cellular immunity
Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Apr 2022
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna Graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338736
- Sponsor's protocol ID
- Immune-COVID
- Status last verified
- Jul 2022
- First submitted
- 19 Apr 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual patients data will be shared only after the publication of the study on an international peer-reviewed journal and on scientific and intelligible proposal
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Humoral and Cellular Immunity in First-cycle Vaccinated Patients Infected by SARS-COV-2: an Observational Study
- ClinicalTrials.gov ID
- NCT05338736
- Acronym / sponsor ID
- Immune-COVID
- Conditions
- SARS CoV 2 Infection, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 21 Apr 2022 (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.
Infection by the recent Coronavirus (SARS-CoV-2) has generated at a pandemic level a new pathology, called COVID-19, characterized by "flu-like" symptoms up to severe acute respiratory failure. The pathogenesis of the disease involves both humoral and cellular immunological responses; cell-mediated immunity is the first and most effective immune response to viral infection. To date, despite the extensive scientific research aimed at curing COVID-19, there are few effective means to tackle SARS-CoV-2 infection and reduce its disease progression. Among these, a first complete anti-SARS-CoV-2 vaccination course has been shown to significantly reduce the development of the disease towards the more severe forms requiring hospital and intensive care. On the other hand, over time the antibody response induced by vaccines against SARS-CoV-2 decreases, so much so as to indicate the need for a third booster dose. This translates into the fact that some patients who have undergone a complete first vaccination course, with third dose booster indications, develop severe critical disease, with the need for hospitalization. On the other hand, other patients with the same vaccination status do not develop the disease, although they are also positive for SARS-CoV-2. The investigators therefore hypothesized that the humoral and cell-mediated response among groups of patients may be radically different. For these reasons, the investigators designed this observational pilot study in order to analyze humoral and cell-mediated responses in SARS-CoV-2 positive first complete vaccination patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin), Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin), Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)Control patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, and with a nasopharyngeal swab negative for SARS-CoV-2 isolation. |
| Asymptomatic group | – | Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin), Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin), Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)Patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, with a nasopharyngeal swab positive for SARS-CoV-2 isolation, in absence of any symptoms of COVID-19 |
| Symptomatic group | – | Diagnostic Test: LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin), Diagnostic Test: LIAISON SARS-CoV2-IgM (DiaSorin), Diagnostic Test: Human IFN-g ELISpot PLUS (ALP) (AUROGENE)Patients with a complete first-cycle vaccination against SARS-CoV-2, received between 4 to 7 months before the inclusion, with a nasopharyngeal swab positive for SARS-CoV-2 isolation, with moderate to severe symptoms of COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Forty-five patients will be totally enrolled in the study. Three cohorts of patients will be considered. 1. Control group: 15 vaccinated patients with a pharyngeal swab negative for SARS-CoV-2 isolation 2. Asymptomatic group: 15 vaccinated patients with a pharyngeal swab positive for SARS-CoV-2 isolation and absence of symptoms related to the infection 3. Symptomatic group: 15 vaccinated patients with a pharyngeal swab positive for SARS-CoV-2 isolation and presence of moderate to severe symptoms related to the infection (i.e. peripheral oxygen saturation lower than 94% in room air)
Key inclusion criteria (1 listed)
- Patients with a complete first-cycle vaccination against SARS-CoV-2 performed 4 to 7 months before.
Key exclusion criteria (6 listed)
- Presence of malignancy under chemotherapy
- Patient with previous transplantation
- Patient receiving immuno-modulatory or immunosuppressive drugs
- Patient receiving corticosteroid therapy since more than 10 days
- Pregnancy
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 |
|---|---|---|
| LIAISON SARS-CoV-2 TrimericS IgG (DiaSorin)Kit to test the concentration of Immunoglobulin G anti-SARS-CoV-2 in the plasma of included patients | Diagnostic test | Asymptomatic group, Control group, Symptomatic group |
| LIAISON SARS-CoV2-IgM (DiaSorin)Kit to test the concentration of Immunoglobulin M anti-SARS-CoV-2 in the plasma of included patients | Diagnostic test | Asymptomatic group, Control group, Symptomatic group |
| Human IFN-g ELISpot PLUS (ALP) (AUROGENE)Kit to test the cellular immunity response by measuring the Interferon gamma released by mononuclear cells (PBMCs) | Diagnostic test | Asymptomatic group, Control group, Symptomatic group |
Primary outcome
Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins
Time frame: At day 0
After obtaining plasma of included patients, the plasma will be processed with a dedicated kit to measure the concentration of Immunoglobulin G and M. Differences between patients' cohorts will be assessed
Differences between populations with respect to cellular immunity
Time frame: At day 0
Mononuclear immunity cells will be analyzed with a dedicated ELISpot kit to assess their response to SARS-CoV-2
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 19 Jul 2022.
- Individual participant dataSharing planned: Yes. The individual patients data will be shared only after the publication of the study on an international peer-reviewed journal and on scientific and intelligible proposal
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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.
Federico Longhini, MD principal investigator
Magna Graecia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection and COVID-19, run by University Magna Graecia at 1 site in Italy.
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 1 inclusion and 6 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 19 Jul 2022. 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 Italy. 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?
Differences between populations with respect to anti-SARS-CoV-2 immunoglobulins (time frame: At day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2022.