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Specific protection against acute bronchitis associated with nontypeable Haemophilus influenzae.

Acute bronchitis (production of an increased volume of purulent sputum) is a common and serious complication of chronic lung disease, most often associated with nontypeable Haemophilus influenzae [I]. Studies of a rat model of colonization of the bronchus with nontypeable H. influenzae provided evidence that protection against an expansion of colonization involved aspiration of bacteria into the gut, with presentation of bacterial antigen to Peyer's patches, initiating a protection loop that involved specific T lymphocytes [2, 3]. Antigen activation of these T lymphocytes enhanced the rate of recruitment of activated neutrophils, which was possibly mediated by cytokines [2]. To maximize the effect of this "antigen lift pump" -activated intermucosal cell circuit, we developed a strategy of oral immunization using a preparation of killed nontypeable H. influenzae. Four studies have been concluded in populations prone to recurrent episodes of acute bronchitis that have a high rate of colonization. All studies were placebo-controlled, double-blind, randomized, and prospective, and the major end point for protection was reduction in number of episodes of acute bronchitis. The immunization protocol involved a course of two tablets ingested on each of three consecutive mornings, with courses repeated at 28 and 56 days. Each tablet contained 1011 biotype I nontypeable H. influenzae. All studies monitored the effect of immunization on colonization as the incidence of co-