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

Recruiting now · Phase 4

Conditions studied: Acute Febrile Illness, Pneumococcal Infections

In brief

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 with PCV-13. Indeed PCV-13 was shown effective to reduce the incidence of low respiratory tract infections and IPD (bacteraemia and meningitis) in 65-years-old-adults and older. Currently immunization against S. pneumoniae is recommended with PCV-20 for adult patients at-risk for IPD such as immunocompromised (=high-risk patients) and in immunocompetent people with underlying chronic conditions (cardiovascular, liver, pulmonary, kidney diseases and diabetes mellitus) (=medium risk patients). However, vaccine coverage against IPD in adults remains low globally, and does not exceed 5 % in France. Reducing missed opportunities of vaccination for S. pneumoniae is crucial.

Key facts

Study ID

NCT06822907

Run by

Centre Hospitalier Universitaire de Saint Etienne

People needed

1052

Starts

2025-12-17

Expected to finish

2028-10-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU de Saint-Etienne — Saint-Etienne, France, France (enrolling)
• 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
• Centre Hospitalier Universitaire — Dijon, France
• Centre Hospitalier Universitaire — Grenoble, France
• Centre Hospitalier — La Roche-sur-Yon, France
• Centre Hospitalier General — Le Mans, France
• Centre Hospitalier — Le Puy-en-Velay, France
• Centre Hospitalier Universitaire — Lille, France
• Hospices Civils de Lyon — Lyon, France
• Centre Hospitalier Regional Universitaire — Montpellier, France
• Centre Hospitalier Universitaire — Nancy, France
• Centre Hospitalier Universitaire — Nantes, France
• Centre Hospitalier Universitaire — Nice, France
• Centre Hospitalier Universitaire — Nîmes, France
• Centre Hospitalier Bichat — Paris, France
• Assistance Publique Hopitaux de Paris — Paris, France
• Centre Hospitalier Universitaire — Rennes, France
• Centre Hospitalier — Annecy, France
• Centre Hospitalier Universitaire — Rouen, France

Full record on ClinicalTrials.gov

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