Clinical Results Of Vaccine Trial Are Promising.(Helivax for gastrointestinal infections caused by Helicobacter pylori)

2001 SEP 19 - (NewsRx.com & NewsRx.net) --

Antex Biologics, Inc. announced results from the Phase IB clinical trial of Helivax, a vaccine intended to prevent and treat gastrointestinal infections and disease caused by Helicobacter pylori.

The Phase IB results continue to show the vaccine to be safe and immunogenic. Helivax's safety profile showed no serious adverse events following five oral doses as compared with three doses administered in the Phase IA clinical trial. Similar to the results of the Phase IA clinical trial, the vaccine stimulated mucosal antibody responses that correlate with protection against infection and disease.

Additional analyses of cellular immune responses are underway and will be reported upon completion. Antex is currently preparing for the initiation of Phase II clinical trials.

Helivax is an inactivated whole-cell H. pylori vaccine produced using Antex Biologics' Nutriment Signal Transduction (NST) technology. The objectives of the Phase IB clinical trial were to compare immune responses and clinical tolerance following oral administration of five doses of the vaccine formulated in different buffer solutions and with varying amounts of adjuvant. The Phase IA clinical trial examined safety and immune responses following three doses of varying concentrations of the vaccine, with the same dose of adjuvant and buffer solution.

Forty-five healthy, uninfected adults participated in the Phase IB trial. No serious adverse events were reported. Mild gastrointestinal symptoms were observed in a very small number of subjects, and these symptoms were self-limiting and related to the buffering solutions. The vaccine stimulated serum, mucosal, and salivary antibodies against H. pylori. The various buffer solutions did not appear to affect the immune response to the vaccine.

"We are quite pleased with the results from the Helivax Phase IB clinical trial," commented Dr. Vic Esposito, Antex. "Of significance, the vaccine was proven to be safe with no reported serious adverse events, when the number of doses administered in the Phase IB trial increased to five compared with the three doses in the Phase IA trial. Mucosal antibody responses suggest that the vaccine will be protective when used to prevent or eradicate Helicobacter pylori infection.