Spring 2014 - Safety

Vaccine Update

AC Immune has launched the world’s first trial of a vaccine against a protein believed to cause Alzheimer’s. Its ACI-35 vaccine aims to stimulate the immune system to produce antibodies that target the tau protein that forms twisted fibers and tangles inside the brain. The company has another vaccine, ACI-24, in Phase I/IIa clinical trials to prevent and clear amyloid plaques, another hallmark of the fatal brain-wasting disease.


A worldwide clinical trial that tests a newly developed clostridium difficile (C-diff) vaccine is seeking study participants. The Cdiffense vaccine, which was granted fast track approval by the U.S. Food and Drug Administration in 2010, is made by French pharmaceutical company Sanofi Pasteur. The study seeks to enroll 15,000 participants in 17 countries over the next four years. All participants must be 50 years or older who are deemed to be at high risk of developing C-diff, a deadly superbug. Participants will be separated into two groups. Group one will include former patients who have had at least two 72-hour hospital stays in the last 12 months and who have received systemic antibiotics during their stays. Group two will include anyone who anticipates hospitalization for a planned surgical procedure that involves certain areas of the body in the next 60 days and whose planned stay is for at least 72 hours. Those who participate will receive three doses of the vaccine or a placebo within a month’s time. The study will follow up with each participant to see if they contracted C-diff after getting the vaccine. More information can be obtained by calling (877) 500-3788 or visiting www.cdiffense.org.


Researchers at the Instituto Gulbenkian de Ciência and Instituto de Tecnologia Química e Biológica in Portugal and colleagues from the Department of Biochemistry at the University of Washington and The Scripps Research Institute have designed a vaccine for the human-infecting respiratory syncytial virus (RSV). The vaccine was tested in rhesus monkeys (which have a very similar immune system to humans), and proved to induce protective antibodies. Scientists have struggled to make a vaccine for the RSV for a long time without success because, like influenza, hepatitis C and HIV, these viruses change so fast that vaccines (and the immune memory they trigger) become obsolete very quickly. To create the new RSV vaccine, the researchers designed new protein scaffolds that induce epitope-specific neutralizing antibodies (antibodies capable of blocking the effects of the pathogen). According to the researchers, “The results provide proof of principle for epitope-focused and scaffold-based vaccine design, and encourage the evaluation and further development of these strategies for a variety of other vaccine targets, including antigenically highly variable pathogens such as human immunodeficiency virus and influenza.”

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.