The Boyce Thompson Institute for Plant Research Inc. (BTI), an affiliate of Cornell University, announced that clinical trials will begin today (July 7) at Roswell Park Cancer Institute (RPCI) in Buffalo, N.Y., to test the safety and immunogenicity of the world's first potential oral vaccine against the hepatitis B virus. The vaccine will be delivered simply by eating potatoes genetically designed to contain the vaccine.

More than 2 billion people worldwide are affected by the hepatitis B virus, a leading cause of liver cancer and the cause of more than 1 million deaths annually.

This 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 will receive an oral booster dose. The dose will be delivered by the consumption of a sample of transgenic potato that expresses the hepatitis B surface antigen.

The clinical trial will be jointly coordinated by Thanavala and Dr. Martin Mahoney, director of the RPCI Employee Health Clinic and member of the Department of Cancer Prevention, Epidemiology & Biostatistics. They will share responsibility for the conduct of the laboratory testing and clinical assessment, respectively, for the study.

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. 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 University. 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. For further information on RPCI, or to request interviews with Thanavala or Dr. Mahoney, call Deb Pettibone at (716) 845-8593 or fax, (716) 845-8362, or e-mail pettibone@sc3101.med.buffalo.edu.