An interventional study of Blood sample taken in Sepsis, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Prevention
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 175 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for patients positive to Covid-19:
Exclusion Criteria:
Other: Blood sample taken
For patients with sepsis who require vaccination during hospitalization, we will analyze the immunogenicity of pneumococcal conjugate vaccine (PCV13) by taking blood samples
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.
Time frame: at 1 month
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.
Time frame: At inclusion
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.
Time frame: At inclusion
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
Time frame: at 1 month
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.
Time frame: at 1 month
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.
Time frame: at 1 month
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.
Time frame: At inclusion
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.
Time frame: at inclusion
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
Time frame: at 1 month
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.
Time frame: at 1 month
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice