Dynavax Initiates Large-Scale Phase III Trial of HEPLISAV™
News Feb 09, 2010
Dynavax Technologies Corporation announced initiation of a large-scale Phase III trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV™, the Company's investigational adult hepatitis B vaccine.
This study and the ongoing Phase III trial in chronic kidney disease patients are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. HEPLISAV has been shown in two pivotal Phase III trials to enhance protection and with fewer doses than a currently licensed vaccine.
The lot-to-lot consistency trial will enroll 2,000 patients in Canada and in the U.S., 1600 of whom will receive HEPLISAV. Patients randomized to the comparator arm will receive Engerix-B®, a currently licensed hepatitis B vaccine. The primary objectives are:
• Non-inferiority of the immune response to HEPLISAV vaccination as measured by the seroprotection rate at 8 weeks after the last active dose, compared to Engerix-B vaccination at 8 weeks after the last active dose; and
• Lot-to-lot consistency for immune response as measured by geometric mean concentration at 4 weeks after the last active dose among 3 consecutively manufactured lots of HEPLISAV.
The secondary objectives include the safety of HEPLISAV as compared to Engerix-B.
Data from this trial is expected in the first half of 2011. The hepatitis B surface antigen in the HEPLISAV lots being evaluated was produced in Dynavax's manufacturing facility in Duesseldorf, Germany. This facility was recently upgraded and licensed in the European Union for commercial production of hepatitis B surface antigen.
Autism Risk Higher if Pregnant Mothers Have Infection Requiring HospitalizationNews
Studies have shown that mothers who experience an infection severe enough to require hospitalization during pregnancy are at higher risk of having a child with autism.READ MORE
£2.2M Collaboration to Fuel Drug Developments for HIVNews
A collaboration between the University of Liverpool and the Johns Hopkins University School of Medicine (JHUSM) has been awarded a further £2.2M ($3M) to develop sophisticated new medicines for HIV.READ MORE
Human Organ-on-a-Chip Project Launched to Model Influenza InfectionNews
The Wyss Institute for Biologically Inspired Engineering have developed a human Organ-on-a-Chip (Organ Chip) microfluidic cell culture technology to develop clinically relevant in vitro models of influenza infection.READ MORE
Comments | 0 ADD COMMENT
22nd Edition of International Conference on Biotechnology
Apr 16 - Apr 18, 2018