Negligible adjuvant effect for antibody responses and frequent adverse events associated with IL-12 treatment in humans vaccinated with pneumococcal polysaccharide.

To assess whether co-administration of recombinant human IL-12 (rhIL-12) and 23-valent pneumococcal polysaccharide vaccine (PPV) enhances the antibody response to this T cell-independent antigen, healthy immunocompetent volunteers (n=34, 55-65 years old) were vaccinated intramusculary with PPV and concurrently-treated subcutaneously with either rhIL-12 (1 or 4 microg) or placebo. The increases of total anti-pneumococcal IgG antibodies were numerically higher among the rhIL-12 recipients compared with placebo recipients, but the difference was not significant. The rhIL-12 recipients had a high incidence of local and systemic side effects. Given the lack of convincing evidence that rhIL-12 enhances the antibody response to PPV, the frequency and severity of the side effects was unacceptable.

RCT Entities:   Population Interventions Outcomes