Vaccine Response in Patient With Sepsis (Vaccis)
Primary Purpose
Sepsis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample taken
Sponsored by
About this trial
This is an interventional prevention trial for Sepsis
Eligibility Criteria
Inclusion Criteria for all patients:
- Age ≥ 18 years old and <80 years old
- Planned length of hospital stay in infectious disease department ≥ 48 hours
- Indication for vaccination against pneumococcus according to the 2013 HAS recommendations
- Vaccination planned as part of the usual care
- Patient hospitalized for sepsis meeting the sepsis criteria according to the latest consensus of 2016 or SIRS ≥ 2 with documented infection
- Patient having signed the free and informed consent form
- Subject affiliated to social security
Inclusion Criteria for patients positive to Covid-19:
- PCR SARS-COV 2 > 0 within 28 days priodi admission and/or,
- scanner compatible with SARS-COV 2 infection.
Exclusion Criteria:
- Pregnant or breastfeeding women,
- Vulnerable people
- Pneumococcal vaccination according to the prime-boost scheme already carried out less than 5 years old
- Pneumovax vaccination <1 year
- Known hypersensitivity to the active substances or to any of the excipients or to diphtheria toxoid.
- IgG level> 1 µg / mL among more than 75% of serotypes at inclusion
- Withdrawal of consent
Sites / Locations
- University Hospital of Nice
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vaccination in patient with sepsis
Arm Description
Outcomes
Primary Outcome Measures
Assess vaccine response rate at 1 month in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
PCV13 vaccine response rate will be measured by an ELISA method certified by WHO. Immunoglobulin G level measurements will be performed on 13 pneumococcal vaccine serotypes to analyze the vaccine response rate of patients.
Secondary Outcome Measures
Evaluate cellular immunity in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination, at inclusion
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Identifiy the threshold of cellular immunity by the rate of gamma interferon (IFN) before vaccination (at inclusion) in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Identify vaccine non-response risk factors at 1 month after vaccination, in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
Anamnestic and clinical factors of vaccine non-response will be studied
Assess the diagnostic performance (validity and reliability) of the vaccine response of PV13 at 1 month, in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination, assessed by an IgG VaccZymeTM anti-PCP ELISA method.
Diagnostic performance (validity and reliability) of the vaccine response of PV13 will be assessed by an IgG VaccZymeTM anti-PCP ELISA method from The Binding site and the WHO validated ELISA method. Vaccinal response level from both methods will be compared.
Assess vaccine response rate at 1 month in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
PCV13 vaccine response rate will be measured by an ELISA method certified by WHO. Immunoglobulin G level measurements will be performed on 13 pneumococcal vaccine serotypes to analyze the vaccine response rate of patients.
Evaluate cellular immunity in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination, at inclusion
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Identifiy the threshold of cellular immunity by the rate of gamma interferon (IFN) before vaccination (at inclusion) in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Identify vaccine non-response risk factors at 1 month after vaccination, in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
Anamnestic and clinical factors of vaccine non-response will be studied
Assess the diagnostic performance (validity and reliability) of the vaccine response of PV13 at 1 month, in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination, assessed by an IgG VaccZymeTM anti-PCP ELISA method.
Diagnostic performance (validity and reliability) of the vaccine response of PV13 will be assessed by an IgG VaccZymeTM anti-PCP ELISA method from The Binding site and the WHO validated ELISA method. Vaccinal response level from both methods will be compared.
Full Information
NCT ID
NCT04823039
First Posted
March 23, 2021
Last Updated
August 2, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04823039
Brief Title
Vaccine Response in Patient With Sepsis
Acronym
Vaccis
Official Title
Evaluation of Prevenar 13's Vaccine Response in Patients Hospitalized in Infectious Disease Department for Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
June 6, 2023 (Actual)
Study Completion Date
June 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Vaccination is established as an effective means of individual and collective protection. Hospitalization is an opportunity not to be missed to catch up on vaccinations in certain fragile patients. Patients hospitalized in infectious diseases are generally treated for an acute or chronic infection that can modulate their immunity and therefore their vaccine response. Current vaccine immunogenicity data in immunocompromised patients support a lower percentage of responders than observed in immunocompetent patients.
There is little data to assess the vaccine response (VR) in patients treated for an infection (bacteremia, pneumonia, urinary tract infection, etc.). In order to respond to this problem, the investigators have chosen to evaluate the vaccine response to Prevenar 13 (PCV13), a conjugate vaccine recommended as a prime-boost since 2013, which must be followed by a vaccination at 2 months with Pneumovax, an unconjugated vaccine of 23 valences.
Anti-pneumococcal vaccine coverage in frail people (immunocompromised, heart failure, respiratory failure, kidney failure, diabetics) remains low and is estimated at less than 10% in 2011, while the bacteria is responsible for severe invasive infections.
In total, the investigators would like to study the vaccine response at 1 month of vaccination with Prevenar 13 in patients hospitalized in infectious disease for sepsis, in order to demonstrate the benefit of vaccination per hospitalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccination in patient with sepsis
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sample taken
Intervention Description
For patients with sepsis who require vaccination during hospitalization, we will analyze the immunogenicity of pneumococcal conjugate vaccine (PCV13) by taking blood samples
Primary Outcome Measure Information:
Title
Assess vaccine response rate at 1 month in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
Description
PCV13 vaccine response rate will be measured by an ELISA method certified by WHO. Immunoglobulin G level measurements will be performed on 13 pneumococcal vaccine serotypes to analyze the vaccine response rate of patients.
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
Evaluate cellular immunity in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination, at inclusion
Description
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Time Frame
At inclusion
Title
Identifiy the threshold of cellular immunity by the rate of gamma interferon (IFN) before vaccination (at inclusion) in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
Description
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Time Frame
At inclusion
Title
Identify vaccine non-response risk factors at 1 month after vaccination, in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
Description
Anamnestic and clinical factors of vaccine non-response will be studied
Time Frame
at 1 month
Title
Assess the diagnostic performance (validity and reliability) of the vaccine response of PV13 at 1 month, in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination, assessed by an IgG VaccZymeTM anti-PCP ELISA method.
Description
Diagnostic performance (validity and reliability) of the vaccine response of PV13 will be assessed by an IgG VaccZymeTM anti-PCP ELISA method from The Binding site and the WHO validated ELISA method. Vaccinal response level from both methods will be compared.
Time Frame
at 1 month
Title
Assess vaccine response rate at 1 month in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
Description
PCV13 vaccine response rate will be measured by an ELISA method certified by WHO. Immunoglobulin G level measurements will be performed on 13 pneumococcal vaccine serotypes to analyze the vaccine response rate of patients.
Time Frame
at 1 month
Title
Evaluate cellular immunity in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination, at inclusion
Description
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Time Frame
At inclusion
Title
Identifiy the threshold of cellular immunity by the rate of gamma interferon (IFN) before vaccination (at inclusion) in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
Description
Cellular immunity will be assessed by a gamma interferon level, after non-specific stimulation of T and NK lymphocytes in the PMBC surnageant of patients cultured before vaccination (at inclusion). This level will be determined with the QFM (QuantiFERON Monitor®) test.
Time Frame
at inclusion
Title
Identify vaccine non-response risk factors at 1 month after vaccination, in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
Description
Anamnestic and clinical factors of vaccine non-response will be studied
Time Frame
at 1 month
Title
Assess the diagnostic performance (validity and reliability) of the vaccine response of PV13 at 1 month, in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination, assessed by an IgG VaccZymeTM anti-PCP ELISA method.
Description
Diagnostic performance (validity and reliability) of the vaccine response of PV13 will be assessed by an IgG VaccZymeTM anti-PCP ELISA method from The Binding site and the WHO validated ELISA method. Vaccinal response level from both methods will be compared.
Time Frame
at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for all patients:
Age ≥ 18 years old and <80 years old
Planned length of hospital stay in infectious disease department ≥ 48 hours
Indication for vaccination against pneumococcus according to the 2013 HAS recommendations
Vaccination planned as part of the usual care
Patient hospitalized for sepsis meeting the sepsis criteria according to the latest consensus of 2016 or SIRS ≥ 2 with documented infection
Patient having signed the free and informed consent form
Subject affiliated to social security
Inclusion Criteria for patients positive to Covid-19:
PCR SARS-COV 2 > 0 within 28 days priodi admission and/or,
scanner compatible with SARS-COV 2 infection.
Exclusion Criteria:
Pregnant or breastfeeding women,
Vulnerable people
Pneumococcal vaccination according to the prime-boost scheme already carried out less than 5 years old
Pneumovax vaccination <1 year
Known hypersensitivity to the active substances or to any of the excipients or to diphtheria toxoid.
IgG level> 1 µg / mL among more than 75% of serotypes at inclusion
Withdrawal of consent
Facility Information:
Facility Name
University Hospital of Nice
City
Nice
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Vaccine Response in Patient With Sepsis
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