PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for its single-dose oral cholera vaccine, clearing the way to begin clinical trials. The company intends to begin Phase 3 trials later this year.
Cholera is an acute intestinal infection caused by toxigenic Vibrio cholerae bacterium. Cholera infections are most commonly acquired from ingesting contaminated water or food. Infection causes severe watery diarrhea and even death if not treated promptly. According to the World Health Organization, the global disease burden is estimated to be 3-5 million cases and 100,000-130,000 deaths per year.
PXVX-0200, is a single dose, oral, live, attenuated vaccine against cholera, which was previously approved and marketed in six countries under the brand name "Orochol." Unlike currently available cholera vaccines requiring two doses over the course of weeks before effectiveness, this vaccine's rapid onset of protection in as little as seven days after a single administration makes it ideal for people preparing to travel to areas where cholera is endemic or where it has recently caused an epidemic.
"We expect our cholera vaccine will be the first vaccine for cholera available in the United States, and the only one-dose oral vaccine in the world," said Kenneth Kelley, Chief Executive Officer of PaxVax. "Further, given that cholera is classified as a neglected tropical disease by the FDA, this product should qualify us for a priority review voucher."