Novavax has announced that it has begun vaccinating healthy volunteers in the first human clinical trial of its virus-like particle ("VLP") based pandemic influenza vaccine.
The Phase I/IIa randomized, placebo-controlled clinical trial will evaluate the safety and immunogenicity of different doses of the H5N1 clade 2 VLP influenza vaccine in up to 230 healthy adults. The goals of the study are to demonstrate safety and to select a dose for evaluation in a Phase IIb immunogenicity study. The first subject was enrolled at Healthcare Discoveries in San Antonio, Texas, one of two U.S. clinical sites participating in the study.
Novavax is developing vaccines to treat influenza and other viral diseases based upon VLP technology. The technology creates vaccine particles in cell culture that mimic the three-dimensional structure of the virus, but do not contain genetic material and cannot replicate. The flu VLPs are designed to have a favorable safety profile and potentially be more immunogenic than current pandemic vaccines, without the use of an adjuvant. Recent preclinical studies have supported this hypothesis by showing that Novavax's influenza VLPs induced a robust immune response.
"The start of this clinical study represents a major milestone in the company's strategy to develop novel and improved vaccines for the 21st Century," stated Penny Heaton, M.D., Novavax Vice President and Chief Medical Officer. "The pandemic influenza vaccine is the first application of our proprietary VLP technology against a looming public health problem."
"To create a novel vaccine clinical candidate within two years of focusing Novavax into a vaccine company is testament to our employees' diligence and belief in our mission. The value of this clinical trial is far reaching since it will help us better understand the broad potential of the Company's novel VLP vaccine technology platform with key human data," stated Rahul Singhvi, Chief Executive Officer.