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

RecruitingPhase 4Ages 18 Years - 85 YearsAllCentre Hospitalier Universitaire de Saint Etienne
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In plain words

What the trial is, and whether it could suit you

Streptococcus pneumoniae is responsible for serious infections associated to numerous hospitalizations and high rate of mortality. The incidence and therefore the burden of pneumococcal infections have been significantly reduced thanks to the use of pneumococcal conjugate vaccines (PCVs). PCVs were shown to be effective against vaccine-type serotypes causing both non-invasive and invasive pneumococcal diseases (IPD) in children and adults. PCVs use in children was shown to have an impact on IPD incidence among adults due to herd immunity and on antimicrobial resistance. To increase the protection of at-risk patients against IPD, the 20-valent PCV (PCV-20) is recently recommended in adults, after a period where PCV-13 followed by pneumococcal polysaccharide vaccine 23 valent (PPV-23) was recommended. PCV-20 effectiveness against IPD and against pneumonia was inferred from immunobridging w

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📋 Eligibility rules (as published)
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; Age \> 65 years old. * 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
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What it tests

  • Early intervention
  • Delayed intervention
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Where

24 sites
CHU de Saint-Etienne
Saint-Etienne, France
Centre Hospitalier
Annecy, France
Centre Hospitalier Universitaire
Besançon, France
Centre Hospitalier
Bordeaux, France
Centre Hospitalier Universitaire
Brest, France
Centre Hospitalier
Brest, France
Centre Hospitalier General Metropole Savoie
Chambéry, France
Centre Hospitalier de Creteil
Créteil, France

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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