Vaccine Response in Patient With Sepsis

NCT04823039 | Completed DMC

• 1 other identifier: 20-PP-25
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 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.

  at 1 month

Secondary Outcomes (9)

• Evaluate cellular immunity in patients with sepsis, negative to Covid-19, with an indication for pneumococcal vaccination, at inclusion

  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

  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

  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.

  at 1 month

• Assess vaccine response rate at 1 month in patients with sepsis, positive to Covid-19, with an indication for pneumococcal vaccination

  at 1 month

Study Arms (1)

Vaccination in patient with sepsis

OTHER

Other: Blood sample taken

Interventions

Blood sample taken OTHER

For patients with sepsis who require vaccination during hospitalization, we will analyze the immunogenicity of pneumococcal conjugate vaccine (PCV13) by taking blood samples

Vaccination in patient with sepsis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• PCR SARS-COV 2 \> 0 within 28 days priodi admission and/or,
• scanner compatible with SARS-COV 2 infection.

You may not qualify if:

• 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.
• Withdrawal of consent

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

University Hospital of Nice

Nice, Provence-Alpes-Côte d'Azur Region, 06000, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: April 19, 2021
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: August 3, 2023

Record last verified: 2023-08

Locations

FR (1)