Vical Incorporated announced the enrolment of the first subject in its phase-1 trial of the company's Vaxfectin-formulated plasmid DNA (pDNA) pandemic influenza vaccine. The trial will be conducted in collaboration with the US Naval Medical Research Center (NMRC).
"The H1N1 outbreaks in 2009 served as a wake-up call highlighting the need for more responsive vaccine technologies," said Vijay B. Samant, Vical's president and chief executive officer. "Future pandemics are inevitable, and could become more frequent with increasingly crowded living conditions in developing countries coupled with more widespread international travel. Through our ongoing collaboration with the US government, we are leveraging the success of our H5N1 influenza vaccine trials toward establishing Vical's DNA vaccine platform to address future emerging infectious disease threats."
Vical's vaccine contains plasmid DNA encoding a hemagglutinin (HA) surface protein from the H1N1 influenza virus strain, A/California/04/09. The vaccine is formulated with the company's Vaxfectin adjuvant, which has demonstrated effectiveness with a variety of DNA vaccines in multiple animal models as well as initial human testing in the H5N1 DNA vaccine phase-1 trial. It has also demonstrated dose-sparing and immune-enhancing ability with a conventional seasonal influenza vaccine in animals.
The double-blind, placebo-controlled H1N1 influenza vaccine phase-1 trial will enrol approximately 30 healthy adult volunteers at a single US clinical site. Subjects will be randomized 2:1 into the vaccine or placebo arms of the trial. Vaccine will be administered on days 0 and 21, and immunogenicity assessments will continue through the final 6-month follow-up visit.
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.