A U.S. Phase I human clinical trial of the H1N1 influenza vaccine produced positive results, according to a PRNewswire press release.
Medicago Inc., a biotechnology company that develops highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), made the announcement Wednesday.
All of the influenza vaccine doses were found to be safe and well-tolerated. The vaccine also produced a solid immune response, the press release said.
Upon regulatory approval, Medicago will proceed with phase II of the trial, which will include a trivalent vaccine for H1N1, H3N2 and B influenza strains.
According to the press release, published by Yahoo! News Network, Andy Sheldon, President and CEO of Medicago, made the following statement: "These positive U.S. clinical trial results are an important milestone as they continue to demonstrate that our rapid plant-based vaccine technology is both safe and effective. Our VLP vaccine was well-tolerated at all dosage levels. In addition, all dosage levels, including our lowest 5ug dose, generated a robust immune response exceeding the CHMP (Committee for Medicinal Products for Human use) immunogenicity criteria. These remarkable results are a testament to the quality of our VLP vaccine technology. We continue to believe our effective vaccine candidate, coupled with our rapid response and low cost manufacturing system offers unique advantages in the development of seasonal and pandemic influenza vaccine candidates."
