Vaccine Response in Patient With Sepsis (Vaccis)

Centre Hospitalier Universitaire de Nice

Status: Completed

Conditions: Sepsis

Treatments: Other: Blood sample taken

Study type: Interventional

Funder types: Other

Identifiers

NCT04823039

20-PP-25

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

Vaccination in patient with sepsis

Other group

Treatment:

Other: Blood sample taken