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UMB Licensee PaxVax Announces Randomized Placebo-Controlled Study Provides Encouraging Results for a Higher Dose Formulation of Vaxchora® (CVD 103-HgR)

Thursday, December 14, 2017

This article was originally published on The Buffalo New

Randomized Placebo-Controlled Study Provides Encouraging Results for a Higher Dose Formulation of Vaxchora® (CVD 103-HgR) as a Potential Tool in Containing Cholera Epidemics

REDWOOD CITY, Calif., Dec. 6, 2017 /PRNewswire/ -- PaxVax announced findings from a study published in the December 2017 issue of Clinical and Vaccine Immunology that shows the utility of a single high-dose CVD 103-HgR live oral cholera vaccine in developing country settings. The study was conducted in the West African country of Mali. Results support potential future development of a new formulation of Vaxchora®—single high-dose CVD 103-HgR—as an important additional tool for global cholera control in developing countries.

"Immunization with a single-dose cholera vaccine that could rapidly protect people in developing countries who have not previously been exposed to cholera would be a significant asset in helping control outbreaks and lower mortality rates," said Myron M. Levine, M.D., D.T.P.H., Professor, Associate Dean for Global Health, Vaccinology & Infectious Diseases, Founder & Former Director, Center for Vaccine Development, University of Maryland School of Medicine and lead author in the Clinical and Vaccine Immunology study. "Given the highly encouraging results, we recommend that high-dose CVD 103-HgR is evaluated in developing countries as a matter of priority."

"The data published in Clinical and Vaccine Immunology is a first step in demonstrating the potential utility of a new formulation of Vaxchora (CVD 103-HgR) at a higher dose in endemic settings," said Nima Farzan, Chief Executive Officer and President of PaxVax. "In line with our social mission and our commitment to ensuring that our vaccines are available to at-risk populations, we are looking forward to engaging with partners and the global cholera community to undertake additional trials in cholera endemic areas further evaluating high dose CVD 103‑HgR."

Additional research will assess whether CVD 103-HgR is suitable in vaccination campaigns during outbreaks, for preemptive vaccination to diminish the burden of seasonal endemic cholera in developing country settings and for protection of high-risk populations, such as children.

About Cholera and Cholera Vaccines
Cholera, an intestinal infection transmitted by ingestion of food and water contaminated with Vibrio cholerae, presents a global public health challenge. It can cause fever, diarrhea, vomiting, painful cramping and dehydration. In severe cases, patients pass large amounts of diarrhea—up to one liter per hour—that causes rapid dehydration and can lead to death if left untreated. Cholera transmission is endemic in many areas of Africa, Asia and the Caribbean. There are an estimated three million cases of cholera worldwide every year. Outbreaks, such as the ones recently seen in Yemen, Bangladesh and Haiti, continue to have devastating effects on public health and can cause massive social disruption and high rates of deaths, especially in developing countries that lack infrastructure, modern sanitation and access to clean water.   

While there is a World Health Organization (WHO) stockpile of cholera vaccines for outbreak control, currently available vaccines are two dose regimens, administered two weeks apart. These vaccines have been useful in reducing seasonal increases in cholera rates in areas where this disease is endemic and where targeting of populations is possible, despite the logistical challenges of providing a second dose and the limitations of immune responses in young children.

Click here to read the rest of the story via The Buffalo News