Clinical trial NCT04823039: Vaccine Response in Patient With Sepsis
Official title: Evaluation of Prevenar 13's Vaccine Response in Patients Hospitalized in Infectious Disease Department for Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Assess vaccine response rate at 1 month in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination
timeFrame: at 1 month
Secondary outcomes:
measure: Evaluate cellular immunity in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination, at inclusion
timeFrame: At inclusion
measure: 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
timeFrame: At inclusion
measure: 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
timeFrame: at 1 month
measure: 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.
timeFrame: at 1 month
measure: Assess vaccine response rate at 1 month in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination
timeFrame: at 1 month
measure: Evaluate cellular immunity in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination, at inclusion
timeFrame: At inclusion
measure: 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
timeFrame: at inclusion
measure: 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
timeFrame: at 1 month
measure: 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.
timeFrame: at 1 month
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
state: Provence Alpes Cote d'Azur
Study officials:
References: