Pyrexia Trials in Disease

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

This clinical trial is examining how the 20-valent pneumococcal conjugate vaccine (PCV-20), also known as Prevenar 20, works in adults who have fever and are at medium or high risk for pneumococcal infections. Pneumococcal bacteria can cause serious illnesses including pneumonia, meningitis, and bloodstream infections. The vaccine is designed to protect against 20 different types of these bacteria.

Main focus: The trial aims to compare whether the vaccine produces a similar immune response when given during an acute febrile illness (when someone has a sudden fever) versus when it is given 15 to 58 days after the fever has gone away. Researchers will monitor the immune response one month after vaccination and track any side effects or reactions that occur within a month of receiving the vaccine. The study will also follow participants for one year to observe respiratory infections and confirmed pneumococcal infections, as well as examine gut bacteria diversity and specific immune markers.

Who can participate: Adults between 18 and 84 years old who meet the following criteria:

• Have had a body temperature of at least 38°C (100.4°F) measured at least twice before joining the study
• Have been hospitalized for more than 24 hours
• Have at least one health condition that puts them at medium or high risk for pneumococcal infection, such as:
  • Medium risk conditions: chronic heart failure, long-term breathing problems like COPD or severe asthma, long-term kidney or liver problems, diabetes requiring treatment, certain heart defects, or fluid leaking from around the brain
  • High risk conditions: having no spleen or a poorly functioning spleen, inherited immune system problems, living with HIV, having had an organ transplant, taking immune-suppressing medications for chronic autoimmune diseases, or having nephrotic syndrome
• Have social security coverage and provide signed informed consent

Who cannot participate: The trial excludes patients who have already been vaccinated against pneumococcal infections. It also has specific timing requirements based on whether vaccination occurs during fever or after fever resolution.

Investigational drug: The 20-valent pneumococcal conjugate vaccine (PCV-20) is administered as an intramuscular injection using a pre-filled syringe. This vaccine helps the body build immunity against 20 different types of pneumococcal bacteria, reducing the risk of serious infections. The trial is testing whether the vaccine works equally well when given during a fever compared to after the fever has subsided.

Study process: Participants are randomly assigned to one of two groups. One group receives the vaccine while experiencing fever, and the other group receives it 15 to 58 days after their fever has resolved. The immune response is evaluated at one month and again at one year after vaccination. Safety is monitored by tracking any adverse events, local reactions at the injection site, or systemic effects related to the vaccination.