CRANBURY, N.J.--(BUSINESS WIRE)--VaxInnate Corporation today announced that enrollment has commenced in a Phase I clinical trial to evaluate VAX161, its novel H5 vaccine candidate in development for the prevention of pandemic avian influenza or bird flu. VaxInnate is a biotechnology firm pioneering breakthrough technology for developing novel vaccines.
The study is being conducted under VaxInnate’s contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS). The trial will evaluate the safety and immunogenicity of VAX161.
The dose-ranging study evaluates the safety and immunogenicity of two doses of VAX161 given by intramuscular injection three weeks apart at six dose levels ranging from 1µg to 12 µg. The study includes 250 healthy adults aged 18-49 years. The study is expected to yield data that will enable VaxInnate to select the appropriate dose of VAX161 for further development. Results are expected late this year.
“The objective of this study is to optimize the dose, based on the immunogenicity and safety of VAX161,” said David Taylor, MD, Chief Medical Officer. “We believe our vaccine candidate has the potential to be a highly effective and much-needed vaccine for pandemic avian flu.”
VAX161 is a recombinant fusion protein that consists of the globular head domain of the hemagglutinin antigen (HA) of influenza A HA5 Indonesia fused to Salmonella typhimurium flagellin type 2 (STF2), a toll-like receptor 5 (TLR5) ligand. The H5N1 Indonesia strain belongs to the family of highly pathogenic avian influenza viruses. VAX161 is a prototype of what would ultimately be a single-component, two-dose pandemic avian flu vaccine.
Although H5N1 is primarily an influenza virus of birds, it has been infecting humans for at least 25 years. Between 1987 and early 2012, the World Health Organization confirmed H5N1 infections of 584 people and 345 deaths in 15 countries. The human mortality rate resulting from H5 influenza can be as high as 60%. So far, most avian flu infections were transmitted from birds to humans and person-to-person transmission has been limited. However, scientists worry that genetic recombination or mutation will eventually occur, increasing human-to-human transmission and resulting in an outbreak or pandemic. It is this potential that makes avian flu vaccines a global public health priority.
“We believe VaxInnate’s approach to vaccine development holds a great deal of promise for avian flu and look forward to learning more about the potential of VAX161 in this clinical trial,” said principal investigator Casey Johnson, DO of Johnson County Clin-Trial (JCCT) in Lenexa, Kansas. The study is also taking place at Miami Research Associates (MRA) in South Miami, FL, under the supervision of principal investigator Eric Sheldon, MD.
Dr. Johnson, who is board certified in Family Practice, is a co-founder and president of JCCT, which has decades of experience in conducting clinical trials. Dr. Sheldon is Medical Research Director and Director of Rheumatology & Vaccines at MRA, one of the top research centers in the United States.
Dr. Johnson and Dr. Sheldon have each served as principal investigator for more than 200 U.S. clinical trials, many of them involving vaccines.
VaxInnate is a privately-held biotechnology company in Cranbury, NJ that is pioneering breakthrough technology for use in developing novel and proprietary vaccines. VaxInnate’s vaccines focus on infectious diseases, including seasonal and pandemic flu, dengue, malaria, and Clostridium difficile. VaxInnate’s technology has the potential to dramatically improve the potency, manufacturing capacity and cost-effectiveness of vaccines.
In 2011, Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS), awarded a contract to VaxInnate worth up to $196 million over five years to fund the development of seasonal and pandemic flu vaccines using recombinant technology.
VaxInnate has already generated positive Phase I and Phase II clinical data for its flu vaccines. These prototype seasonal and pandemic flu vaccines were also demonstrated to have superior potency in elderly subjects. For more information about VaxInnate, please visit http://www.vaxinnate.com