Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new pneumococcal vaccine called PCV-20 in adults who are experiencing an acute febrile illness, which means they have a fever and possibly other symptoms of infection. The goal is to see how well this vaccine can help protect people who are at higher risk for serious infections caused by the bacteria Streptococcus pneumoniae, which can lead to severe illnesses like pneumonia and meningitis.

To be eligible for the trial, participants must be between 65 and 75 years old and have had a fever of 38°C or higher measured at least twice before joining the study. They also need to have certain health conditions that put them at medium or high risk for these infections, such as chronic heart or lung diseases, diabetes, or weakened immune systems. Participants will receive the vaccine and will be monitored for any side effects or changes in their health. It's important to note that this trial is not yet recruiting participants, and those interested will need to provide informed consent before joining.

Gender

ALL

Eligibility criteria

• Inclusion criteria :
• • History of body temperature ≥ 38°C measured at least twice prior to randomization (Randomization must be performed as soon as possible on a febrile patient or 72 hours after apyrexia at the latest)
• * Having at least one comorbidity that defines patients as medium or high risk for pneumococcal invasive infection:
• • Medium risk: Cyanogenic congenital heart disease; chronic heart failure; chronic respiratory failure; chronic obstructive pulmonary disease; emphysema; severe asthma under chronic treatment; chronic renal failure; chronic liver disease; diabetes mellitus treated; Osteo-meningeal leak or cochlear implant.
• • High risk : Hypo or asplenic people; hereditary immunodeficiency syndromes; people living with HIV; solid organ transplanted; People under immunosuppressors (corticosteroids, biotherapy) for an auto-immune or an inflammatory chronic disease; patients with nephrotic syndrome
• • Hospitalization for \> 24 hours long
• • Social security affiliation
• • Signed informed consent
• Exclusion criteria :
• • Patient unable to give informed consent
• • Curators, wardship
• • History of previous vaccination with PCV-7 or PCV-13 or PCV-20
• • History of PPV-23 in the previous year
• • Patient having received another vaccination within one month prior to inclusion or planning another vaccination in the month after inclusion except for Influenza vaccine.
• • Patient with history of bone marrow transplantation
• • Patient with haematological malignancies
• • Patient under chemotherapy for solid tumor or with a history of chemotherapy in the past three months
• • Patient treated with Rituximab currently or in the past 6 months
• • Patient with Sequential Organ Failure Assessment (qSOFA ) score ≥ 2 at randomization (acute severe febrile illness)
• • Patient hospitalized in an Intensive Care Unit
• • Pregnancy
• • Breastfeeding woman
• • Recipients of polyclonal gammaglobulins in the past three months
• • Inability to follow the protocol
• • Bleeding disorder contra-indicating intramuscular injection according to the investigator
• • History of allergy to PCV-20 or vaccine-related components.
• • S. pneumoniae infection with laboratory confirmation (blood culture, culture from a sterile site, urinary or Cerebrospinal fluid antigens, sputum culture with \> 10\^7 colony forming unit (CFU)/mL) being the cause of the current hospitalization