Immune globulin sulfonated human (KM Biologics/Teijin)

Considerable evidence suggests that otitis media (OM) can be prevented by systemic immunization. Building on the highly effective H. influenzae type b (Hib) conjugate vaccine technology, pneumococcal conjugate vaccines are being developed to circumvent T-independence of these antigens and provide durable immunity at a very young age. Several pneumococcal conjugate vaccines are currently in clinical testing. Potential vaccine antigens of nontypable H. influenzae (NTHi) include OMP, HMW, pili, and fimbriae. Several OMPs show extensive homology among strains, but surface, determinants of others are highly variable so that antibodies to surface epitopes of one strain will not bind to surface epitopes of another. Several M. catarrhalis OMP and HMW antigens have vaccine potential, but no functional correlates of protection have been identified, and there is no clear evidence that antibody to M. catarrhalis is associated with OM protection. Attenuated viral vaccines also hold promise of preventing childhood OM. Two clinical trials with killed influenza vaccines have shown a significant reduction in OM among vaccine recipients compared to control children during periods of high influenza disease activity in the community. Passive immunoprophylaxis also has potential for preventing OM. Human bacterial polysaccharide immune globulin was protective for pneumococcal OM in children and in the chinchilla OM model. High-dose respiratory syncytial virus-enriched immunoglobulin reduced the incidence and severity of RSV lower respiratory tract infection in high-risk children. Passive immunoprophylaxis may also be effective in children with specific immune deficiencies, such as IgG2 deficiency, and patients who fail to respond to vaccines.