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Study on the Safety and Immune Response of the 20-Valent Pneumococcal Vaccine in Adults with Fever and High Risk for Pneumococcal Infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the 20-Valent pneumococcal conjugate vaccine (PCV-20) in adults who are at medium or high risk for pneumococcal infections. Pneumococcal infections are caused by bacteria that can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The vaccine being tested, known as Prevenar 20, is designed to protect against 20 different types of these bacteria. The study aims to compare the immune response of patients who receive the vaccine during an acute febrile illness, which is a sudden fever, to those who receive it after their fever has resolved.

Participants in the study will be randomly assigned to one of two groups. One group will receive the vaccine while they are experiencing a fever, and the other group will receive it 15 to 58 days after their fever has subsided. The study will monitor the immune response of participants one month after vaccination to determine if the timing of the vaccine affects its effectiveness. The study will also track the safety of the vaccine by recording any side effects or reactions that occur within a month after vaccination.

In addition to the primary focus on immune response and safety, the study will also look at other factors over a year, such as the number of respiratory infections and confirmed Streptococcus pneumoniae infections in participants. The study will explore the diversity of gut bacteria and the presence of specific immune cells and antibodies related to the vaccine. This research will help determine the best timing for administering the PCV-20 vaccine to adults at risk for pneumococcal infections.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed based on age, medical history, and current health status. The patient must be between 18 and 85 years old and have a history of fever with a body temperature of at least 38°C measured twice before joining the study.

    The patient must have at least one medical condition that increases the risk of pneumococcal infection, such as chronic heart or lung disease, diabetes, or a weakened immune system.

    The patient must be hospitalized for more than 24 hours and provide signed informed consent.

  2. Step 2

    Randomization and vaccination

    The patient is randomly assigned to one of two groups. One group receives the PCV-20 vaccine during an acute febrile illness, while the other group receives it 15-58 days after the fever resolves.

    The vaccine is administered as an intramuscular injection using a pre-filled syringe.

  3. Step 3

    Monitoring and follow-up

    The patient's immune response is evaluated one month after vaccination. This involves measuring the levels of specific antibodies in the blood to determine if the patient is a 'good responder' to the vaccine.

    The safety of the vaccine is assessed by monitoring for any adverse events, local reactions, or systemic events related to the vaccination.

  4. Step 4

    Long-term follow-up

    The patient's immune response is evaluated again one year after vaccination to assess the long-term effectiveness of the vaccine.

    The frequency of respiratory infections and confirmed pneumococcal infections is recorded until one year after joining the study.

Who can join the trial?

7 criteria

  • Must be between 18 and 84 years old.
  • Must have had a body temperature of at least 38°C (100.4°F) measured at least twice before joining the study. Joining the study should happen as soon as possible when the patient has a fever or within 72 hours after the fever goes away.
  • Must have at least one other health condition that puts them at medium or high risk for serious pneumococcal infection.
    • Medium risk conditions include: certain heart diseases present from birth, chronic heart failure, long-term heart problems, long-term breathing problems, chronic obstructive pulmonary disease (COPD), emphysema, severe asthma needing regular treatment, long-term kidney problems, long-term liver problems, diabetes that requires treatment, fluid leaking from around the brain or a cochlear implant.
    • High risk conditions include: having no spleen or a poorly functioning spleen, inherited immune system problems, living with HIV, having had an organ transplant, taking medications that suppress the immune system (like corticosteroids or biotherapy) for chronic autoimmune or inflammatory diseases, or having nephrotic syndrome (a kidney disorder).
    • Must have been hospitalized for more than 24 hours.
    • Must have social security coverage.
    • Must have signed a form agreeing to participate in the study after being informed about it.

Who cannot join the trial?

5 criteria

  • Patients who are at medium or high risk for a serious infection caused by pneumococcal bacteria cannot participate.
  • Patients who have not been vaccinated against pneumococcal infections are excluded.
  • Patients who are currently experiencing an acute febrile illness, which means they have a sudden fever, are not eligible.
  • Patients who have had an acute febrile illness and have not waited 15-58 days after recovery before receiving the vaccine are excluded.
  • Both male and female patients are considered, but certain vulnerable populations are not included.
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Investigated drugs

20-Valent Pneumococcal Conjugate Vaccine (PCV-20) is a vaccine designed to protect against infections caused by 20 different types of pneumococcal bacteria. These bacteria can lead to serious illnesses such as pneumonia, meningitis, and bloodstream infections. The vaccine works by helping the body build immunity against these bacteria, reducing the risk of getting sick. In this trial, the vaccine is being tested to see if it is just as effective when given during a feverish illness as it is when given after the illness has resolved.

What is already known about the treatment

PCV-20 – This vaccine is administered via injection and is currently being studied in clinical trials to assess its effectiveness and safety. It is designed to protect against pneumococcal infections, particularly in adults at medium or high risk. The vaccine works by stimulating the immune system to recognize and fight the bacteria that cause these infections. It belongs to the class of pneumococcal conjugate vaccines, which are used to prevent diseases caused by pneumococcal bacteria.

Investigated diseases

Pneumococcal Invasive Disease – This disease is caused by the bacterium Streptococcus pneumoniae, which can invade parts of the body that are normally free from germs, such as the blood or the brain. It often begins with symptoms similar to a common cold or flu, such as fever, chills, and cough. As the disease progresses, it can lead to more severe conditions like pneumonia, meningitis, or bacteremia. The progression can vary, with some individuals experiencing mild symptoms while others may develop serious complications. The risk of developing this disease is higher in individuals with weakened immune systems or certain chronic health conditions. Vaccination is a key preventive measure to reduce the risk of infection.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517411-73-00Protocol code24CH249Estimated enrolment1 160 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

sourced from the EU Clinical Trials Register and site verification

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