Immunogenicity and Safety of the 20-Valent Pneumococcal Conjugate Vaccine (PCV-20) During an Acute Febrile Illness in Adults: A Multicenter Randomized Non-inferiority Trial

What this Trial Is About

Researchers are studying adults at risk of invasive pneumococcal disease (IPD), a serious infection caused by Streptococcus pneumoniae that leads to hospitalizations and high mortality. Vaccines called pneumococcal conjugate vaccines (PCVs) have reduced the incidence of these infections. This trial focuses on the 20-valent PCV (PCV-20), recently recommended for adults with certain chronic or immunocompromising conditions. The study aims to understand if giving PCV-20 during an acute non-severe febrile illness is as immune-responsive and safe as giving it after fever resolves. Participants are randomly assigned to one of two groups: one receives a single dose of PCV-20 vaccine during the acute febrile illness or within 72 hours after the fever ends, and the other receives the vaccine between 15 and 58 days after fever resolution. The vaccine is given by injection into the upper arm muscle. This design helps compare early vaccination during fever with delayed vaccination after recovery. During the study, participants are monitored for immune responses to the vaccine one month and one year after vaccination, including antibody levels and T cell activity. Safety is tracked by recording any adverse events or reactions after vaccination. Researchers also observe respiratory infections and pneumococcal infections over a year. The total study period covers vaccination timing, immune assessments, and safety follow-up to evaluate the vaccine's performance and safety in these patients.

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