12 May PaxVax Commences Trial to Modernize Adenovirus Vaccine
MedicalResearch.com Interview with:
Chief Executive Officer & President of PaxVax
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: PaxVax is developing a new and improved version of the vaccine, known as the Modernized Production Adenovirus Vaccine (MPAV) Prototype A. The Company was chosen as the Small Business Innovation Research and Regulatory Sponsor for the development of the Modernized Production Adenovirus Vaccine (MPAV) Prototype A due to the company’s prior experience working with multiple strains of Adenovirus. An Investigational New Drug (IND) application for MPACV was submitted to the U.S. Food and Drug Administration (FDA) on January 30, 2017. The Phase I clinical trial has been initiated and will be conducted at the Larner College of Medicine at the University of Vermont and Cincinnati Children’s Hospital. PaxVax expects to see results of the Phase I clinical trial in early 2018.
Complications of adenovirus 4/7 can include headache, pneumonia, sore throat and eye infections. In severe cases, adenovirus can lead to acute respiratory distress syndrome and other serious complications related to organ system damage (including GI tract and bladder) that can result in death, if left untreated.
MedicalResearch.com: How is the military in particular affected by outbreaks of Adenovirus infections?
Response: According to the CDC, adenoviral respiratory disease has been recognized as a frequent cause of illness in the U.S. active duty military populations, particularly at basic training. Vaccination programs specifically correlated to adenovirus have proven to demonstrate a dramatic decrease in adenovirus outbreaks.
MedicalResearch.com: Why is there a need for a new vaccine?
Response: Although the current vaccine has helped to greatly reduce respiratory illness for U.S. service members, it is based on a process developed in the 1960s, utilizing raw materials that are difficult to source and are not manufactured domestically. Without pursuing process improvements to address existing technical limitations, continued supply of the vaccine cannot be guaranteed.
MedicalResearch.com: What should readers take away from this report?
Response: PaxVax is looking to provide innovative solutions to the manufacturing process and develop a modernized version of the vaccine here in the U.S. Also, we are thrilled to commence Phase I program for the Ad 4/7, as this milestone enables us to advance our mission of developing specialty vaccines that protect against overlooked infectious diseases.
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#PaxVax Initiates Clinical Trials of a Modernized Adenovirus Vaccine in Collaboration with the U.S. Army Medical Materiel Development Activity and the Walter Reed Army Institute of Research to Protect U.S. Military Personnel
Provides overhaul to more than 30-year-old Adenovirus Serotypes 4 and 7 vaccine against leading causes of Acute Respiratory Distress (ARD), which frequently results in severe pneumonia and hospitalization”
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Last Updated on May 12, 2017 by Marie Benz MD FAAD