Mucosal [SIgA] and serum [IgG] immunologic responses in the community after a single intra-nasal immunization with a new inactivated trivalent influenza vaccine.

Influenza morbidity affects entire populations, imposing an enormous burden in economic terms from working days lost. Protection afforded by current vaccines is often unsatisfactory and many individuals remain averse to injections. To counter these drawbacks, we tested an inactive intra-nasal trivalent influenza vaccine on 182 vaccinated and 92 placebo subjects in the community. On study completion 73 and 66% of the subjects were immune to the vaccine's two A strains, 40% (> or=1:40) and 65% (> or=1:20) to its B strain; 30-40% demonstrated a 4x hemagglutination inhibition (HAI) titer increase; GMT titers increased 2.2-2.5x. About 50% of those initially non-immune became immune. A local antibody response to the three vaccine strains was recorded in 31-44% of vaccinees in which 57, 68 and 54% exhibited a mucosal and/or serum antibody response to the A/Johannesburg, A/Nanchang and B/Harbin strains, respectively. A higher dose (40mg) of A/Johannesburg in the vaccine did not influence response. The new vaccine was safe, without side-effects, and offered reasonable protection after one dose. It could thus play an important role in increasing enrollment into immunization programs.