NCT06822907 Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults
| NCT ID | NCT06822907 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Acute Febrile Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,052 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,052 participants in total. It began in 2025-12-17 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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; 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
Contact & Investigator
Elisabeth BOTELHO-NEVERS, MD PhD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT06822907 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Acute Febrile Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06822907 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06822907 currently recruiting?
Yes, NCT06822907 is actively recruiting participants. Contact the research team at Elisabeth.Botelho-Nevers@chu-st-etienne.fr for enrollment information.
Where is the NCT06822907 trial being conducted?
This trial is being conducted at Saint-Etienne, France, Annecy, France, Besançon, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT06822907 clinical trial?
NCT06822907 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Elisabeth BOTELHO-NEVERS, MD PhD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 1,052 participants.