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Campylobacter Vaccine Exhibits Significant Immune Responses in Phase II Clinical Trial.(Brief Article)
2001 JAN 31 - (NewsRx.com & NewsRx.net) -- Antex Biologics Inc. (ANX), Gaithersburg, Maryland, announced that a recently completed Phase II clinical trial of Campyvax, the company's vaccine to prevent Campylobacter infections, showed significant immune responses that correlate with protection against disease.
Development of this vaccine is proceeding; the U.S. Department of Defense will support clinical trials through Phase III. Antex holds all intellectual property and commercial marketing rights to Campyvax.
Campyvax is an oral vaccine for the prevention of gastroenteritis, diarrhea, and "Traveler's Diarrhea" caused by Campylobacter jejuni, a common pathogenic bacteria. The objectives of this randomized, double-blind, placebo-controlled Phase II clinical trial were to compare the safety and immune response achieved following four doses of the vaccine with that achieved following a two-dose regimen during an earlier clinical trial.
Vaccinees achieved a 10-fold increase in mean fecal immunoglobulin A (IgA) antibodies compared to baseline, significantly higher than observed following the two-dose regimen. Over 85% of vaccine recipients were found to have antibody secreting white blood cells, higher than that found among those who received the two-dose regimen. And 85% of individuals who received four doses of the vaccine showed an increase in levels of interferon gamma, an indicator of cellular immunity; a 12-fold mean increase in interferon gamma was observed among vaccine recipients. These cellular immune responses were also higher than those seen among those who received the two-dose regimen, and comparable to the levels observed following infection with Campylobacter.
"The significant mucosal and cellular immune responses to Campyvax demonstrate that this vaccine holds considerable promise to protect against Campylobacter infection and disease," commented Stephen Keith, MD, MSPH, Antex Biologics Inc. "Working with the U.S. Department of Defense, Antex is pioneering the development of vaccines to prevent diarrheal diseases. Campyvax is the only vaccine currently in clinical development to prevent Campylobacter ...
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Source: HighBeam Research, Campylobacter Vaccine Exhibits Significant Immune Responses in Phase...