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(35.3% [1.8-57.4]). The vaccine reduced frequency of infection from vaccine-related cross-reactive pneumococcal serotypes by 65.5%, but did not significantly change the number of episodes caused by other non-vaccine serotypes. Conclusions Use of the H influenzae–derived protein D as a carrier protein for pneumococcal polysaccharides not only allowed protection against pneumococcal otitis, but also against acute otitis media caused by non-typable H influenzae. Whether this approach would also allow improved protection against lower respiratory tract infections warrants further investigation. Commentary In this valid efficacy study, the novel 11-valent pneumococcal conjugate vaccine showed an efficacy against acute otitis media caused by the vaccine serotypes that was almost identical to that demonstrated in a Finnish efficacy study 1 for the currently available 7-valent conjugate vaccine. Interestingly, the vaccine used in this study also seemed to provide protection against acute otitis media caused by non-typable H influenzae. One important point is worth noting: The design of this study apparently resulted in considerable selection of cases, since the observed incidence of acute otitis media in the control group was only about one-tenth of the incidence seen in most U.S. and European studies. The impact of a protein D conjugate vaccine on the overall incidence of acute otitis media in the United States and most of Europe is therefore difficult to anticipate. The relative risk reduction could hardly be as high as 33% since serotype replacement, although not detected during the study, is bound to be associated with the use of this pneumococcal conjugate vaccine also. However, it is reasonable to assume that the impact of this vaccine on pneumococcal otitis would be equivalent to that induced by the currently available vaccine. The observed efficacy of the protein D conjugate vaccine against acute otitis media due to H influenzae indicates that this type of vaccine has even more potential to reduce acute otitis media. |
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