BTI-developed oral plant vaccine has hepatitis B testing

By David Brand

The Boyce Thompson Institute (BTI), an affiliate of Cornell, and Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., one of the nation's largest cancer research centers, are testing the safety and immunogenicity of the world's first potential oral vaccine against the hepatitis B virus. Clinical trials of the vaccine, which is delivered simply by eating potatoes genetically designed to express the hepatitis B surface antigen, began on July 7.

More than two billion people worldwide are affected by the hepatitis B virus, a leading cause of liver cancer and the cause of more than one million deaths annually.

The trial is the culmination of several years of collaborative preclinical work by Charles Arntzen, president and chief executive of BTI, and Hugh Mason, a BTI researcher, and by Yasmin Thanavala, Department of Immunology at RPCI. The program is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).

In the placebo-controlled, double-blind, phase I study, health-care workers who previously responded to a licensed, injectable vaccine, receive an oral booster dose through eating the transgenic potatoes.

BTI generated the potatoes for the clinical trial with financial support from Axis Genetics, of Cambridge, England. "A current vaccine is available to prevent hepatitis B. It is very effective," said Arntzen. "However, cost and inconvenience of needles have limited its acceptance in many countries.

"Alternatives to injectable vaccines are needed if we are to seriously consider global eradication of this disease." he said. "An oral vaccine would also increase its acceptance in this country."

Thanavala noted, "We are very pleased to be taking the next logical step with this research. The continued support of my basic research by the NIH and the World Health Organization, along with the recent collaboration with Axis Genetics, offers us a novel way to impact public health and control hepatitis B worldwide."

Said Mahoney: "This project is a wonderful example of moving research ideas from the laboratory bench to the bedside. We are pleased to participate in this trial to bring this vaccine into a clinical setting."

BTI was founded in 1924 in Yonkers, N.Y., and moved to Ithaca in 1978, affiliating with Cornell. BTI strives to improve human health and well-being and conserve the natural environment through plant research. Its comprehensive research areas include an emphasis on plants for human health.

RPCI, founded in 1898, is the nation's first and one of its largest cancer research, treatment and education centers. It is the only National Cancer Institute-designated comprehensive cancer center in western New York.