REDWOOD CITY, Calif., May 8, 2017 /PRNewswire/ -- PaxVax, a leading independent specialty vaccine company, announced today the initiation of a new clinical trial program – 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.
About Adenovirus Serotypes 4 and 7 (Ad 4/7)
Adenovirus Serotypes 4 and 7 are a leading cause of Acute Respiratory Distress (ARD) in military training facilities, and can lead to a debilitating febrile disease that frequently results in severe pneumonia, hospitalization and occasionally, death. Other symptoms can include headache, pharyngitis, and eye infections. Adenovirus infection can be spread from person to person by aerosols created by sneezing or coughing, but can also be transmitted by close personal contact.
Close living quarters, coupled with the stress of training, can place military recruits at high risk for developing ARD, and prior to the availability of the Ad 4/7 vaccine, epidemics of ARD infections were frequent in all branches of the military. The adenovirus vaccine currently comes as two tablets, taken orally at the same time, and is currently approved for adult military members.1
About PaxVax
PaxVax is a leading independent vaccine company that is devoted to bringing specialty vaccines that protect against overlooked infectious diseases to market, providing effective tools for health care providers who serve the 100 million people per year who travel to countries where these diseases are present. It commercializes vaccines for typhoid fever (Vivotif®) and cholera (Vaxchora™), and has a robust pipeline with vaccines at various stages of preclinical and clinical development for adenovirus, chikungunya, hepatitis A, HIV and Zika. As part of its social mission, PaxVax is also committed to making its vaccines available for use in developing world and increasing access to vaccines for the people who need them most. More information is available at http://www.paxvax.com.
Contact
Nina Toor
Biosector 2
212-845-5609
Nina.Toor@inventivhealth.com
1 Centers for Disease Control and Prevention (CDC). Adenovirus Vaccine Information Statements (VISs). June 2014. Available at: https://www.cdc.gov/vaccines/hcp/vis/vis-statements/adenovirus.html. Accessed March 2017.
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SOURCE PaxVax, Inc.
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