Date: 2013-11-14
Type of information: Results
phase: 1
Announcement: results
Company: Novartis (Switzerland)
Product: vaccine for the H7N9 avian influenza virus
Action mechanism:
Disease: H7N9 avian influenza virus
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On November 14, 2013, Novartis has announced interim results from a Phase 1 clinical trial with its proprietary cell culture vaccine for the H7N9 avian influenza virus involving 400 healthy volunteers (18-64 years of age). The data shows 85% of subjects achieved a protective immune response after two doses of the 15 ug MF59 adjuvanted vaccine. Only 6% of subjects achieved a protective response when given two doses of the 15ug un-adjuvanted vaccine. The full data set from the trial will be submitted to a peer-reviewed journal for publication in the near future.
The vaccine was produced utilizing full-scale cell-culture manufacturing technology.Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.
Reports of H7N9 infection first emerged in China in March 2013. Novartis, along with its partners at the Craig Venter Institute, first synthesized the viral strain several days after it was shared with global researchers by the Chinese Centers for Disease Control. Novartis then produced clinical trial lots, began clinical trials in August, and initiated large-scale production in its Holly Springs (NC), USA and Marburg, Germany facilities in October.
This project has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002012000141
