13-Valent Pneumococcal Conjugate Vaccination to Accelerate Immune Recovery in Sepsis Survivors: a randomized placebo-controlled trial with embedded immunobiology

Although vaccinations may reverse immune impairments, vaccine immunogenicity has never been examined in sepsis survivors. Here, in a 1:1 randomized placebo-controlled trial, we tested the efficacy and immunogenicity of a single intramuscular dose of 13-valent pneumococcal conjugate vaccine (PCV13) in 214 sepsis survivors.

The primary outcome was time to first infection-related rehospitalization or death during 365 days of follow-up. PCV13 immunogenicity assessments included serotype-specific immunoglobulin-G (IgG) concentrations, immunophenotyping and panleukocyte transcriptome, measured at baseline(T0), 10(±3)days(T1), and 30(±7)days(T2) post-randomization. The PCV13 group (n=104) had 43 primary outcome events among 72.5 person-years of follow-up compared with 38 events among 76.5 person-years of follow-up in the placebo group (n=110) [hazard ratio 1.23 (95%CI,0.80-1.91)].