Positive results announced from phase II testing of FluINsure vaccine.

2003 JAN 8 - (NewsRx.com & NewsRx.net) -- ID Biomedical announced positive results on its two phase II clinical trials of FluINsure, the company's intranasally delivered influenza vaccine.

Results of these ongoing, randomized, double-blind, and concurrent placebo-controlled studies, which enrolled a total of 99 healthy adult subjects, confirm the positive results of the previously reported phase I study.

The FluINsure vaccine continued to exhibit a favorable safety and tolerability profile, with no serious adverse events and only mild and transient nasal stuffiness and/or runny nose being associated with the active vaccine when compared with a placebo nasal spray.

Statistically-significant increases in serum hemagglutination-inhibiting (HAI) antibodies were induced by all regimens tested, including both 1- and 2-dose regimens, at 28 days postimmunization. For both influenza A strains included in the vaccine, serum HAI antibody titers increased by an average of 2.4-fold in the 1-dose group and 2.5-fold in the 2-dose groups. Among those subjects who had low pre-existing serum HAI titers prior to immunization with the FluINsure vaccine (suggesting that they were therefore more susceptible to influenza), HAI titers increased an average of 3-fold in one-dose recipients and 4.2-fold in the 2-dose groups. Rises in HAI antibodies to influenza B component were lower in all groups likely because of high levels of pre-existing immunity to the influenza B strain in the study population.

Statistically significant rises in nasal secretory antibody levels of 1.7-3.2-fold were noted in the 2-dose groups. Nasal antibody ...