PaxVax, a leading independent specialty vaccine company, announced today the initiation of a new clinical trial program, in collaboration with the U.S. Army Medical Material Development Activity and the Walter Reed Army Institute of Research to protect U.S. military personnel. This is the first initiative to modernize the Adenovirus Serotypes 4 and 7 (Ad 4/7) vaccine in more than 30 years. PaxVax is developing an updated and improved version of the vaccine. The vaccine, known as the Modernized Production Adenovirus Vaccine (MPAV) Prototype A, will ultimately be administered to U.S. service members during basic training.
An Investigational New Drug (IND) application for MPAV was submitted to the U.S. Food and Drug Administration (FDA) on January 30, 2017. Phase I clinical studies will be conducted at the Larner College of Medicine at the University of Vermont and Cincinnati Children's Hospital.
Adenovirus infection, which can cause Acute Respiratory Distress (ARD), often results in severe pneumonia or hospitalization, and is frequently present in military recruit training facilities. Although the current vaccine has helped to greatly reduce respiratory illness during basic training for U.S. service members, the vaccine is produced via an antiquated process developed in the 1960s that also depends on animal-derived materials, which can be difficult to source and quality control. Without pursuing process improvements to address existing technical limitations, the continued supply of the vaccine cannot be guaranteed. PaxVax is looking to provide innovative solutions to the manufacturing process and also develop a modernized version of the vaccine here in the U.S.
"Our military continues to be at risk from acute respiratory disease," said Jonathan F. Smith, Executive Vice President and Chief Scientific Officer of PaxVax. "We are thrilled to be initiating our clinical development program for the Ad 4/7 vaccine, as this milestone enables us to advance our mission of developing specialty vaccines and contribute to military readiness. We are honored to undertake the modernization of adenovirus vaccine production in order to help support the health and wellbeing of our U.S. troops. Pending successful conclusion of Phase I trials, we look forward to further evaluating the efficacy and safety of this vaccine, and are committed to bringing this vaccine to licensure."
The Small Business Innovation Research (SBIR) program provided the first government funding for this project. PaxVax was chosen as the SBIR contractor due to the company's extensive prior experience with adenoviruses in both preclinical and clinical settings, as well as expertise in Good Manufacturing Practice (GMP) production of adenovirus-based vaccines.
"The current vaccine, which is safe and efficacious, has been in use for a number of years and is given to more than 200,000 enlisted military trainees every year," said Dr. Cliff Snyder, Product Manager for Adenovirus Vaccine at the U.S. Army Medical Materiel Development Activity (USAMMDA). "We are always looking for ways to better protect our military service members. Modernization of production processes offers the opportunity to reduce risks to sustainment and the likelihood of capturing cost savings that result from increasing the efficiencies of processes used in vaccine production."
USAMMDA is the product manager for the MPAV, with Mr. Snyder heading the Integrated Product Team.
The Walter Reed Army Institute of Research will support the study by applying its expertise in virology and immunology to assays of human immune responses.