Winter 2011 - Plasma

Vaccine Update

Antigenics has had promising results of its experimental herpes vaccine in a Phase I clinical trial. The drug, called AG-707, is used to treat herpes simplex virus-2, which causes genital herpes.


Scientists at Stanford University are working on a stress vaccine that would help people relax without slowing them down. The vaccine contains a tailored herpes virus that carries engineered “neuro-protective” genes into the brain to counteract glucocorticoid hormones before they can harm the brain.The vaccine has been proven to work on rats, but human trials still need to be carried out.


An experimental vaccine appears to be safe and effective in protecting people against hepatitis E infection. A Phase III clinical trial in China involved 97,356 healthy participants, half of whom received the vaccine and the other half a placebo. None of those who received the vaccine became infected with the virus, while 15 of those given the placebo did.


Australian researchers are moving toward producing the first-ever vaccine for dengue fever, the potentially life-threatening infection spread by mosquitoes in the tropics. Late-stage clinical trials are under way for the vaccine, which will protect against all four known strains of the disease. Participants are being recruited in Perth, Adelaide and Brisbane.


A flu vaccine patch that has tiny microneedles that inject the vaccine into the skin could be possible in the future. The patch, which was developed in collaboration by researchers at Georgia Tech and Emory University, is placed on the skin and left for five minutes to 15 minutes and can remain longer without doing any damage.When tested on mice, the microneedles delivered a correct dose of the flu vaccine.

Another vaccine patch is being developed at the University of Queensland. Called the Nanopatch, it induces a similarly protective immune response as a vaccine delivered by needle and syringe, but uses 100 times less vaccine. According to the scientists, the patch targets specific antigenpresenting cells found in a narrow layer just beneath the skin surface, and results are 10 times better than those achieved by other delivery methods.


Researchers at the Scripps Research Institute have discovered a potential new way to stimulate the immune system to prevent or clear a viral infection, which could increase the effectiveness of human vaccines designed to prevent viral infections. The researchers found that by blocking a protein called interleukin-10 (IL-10), they can significantly boost immune memory in mice. And, because not all vaccines are 100 percent effective, they hope to enhance vaccination by using this approach. More information can be found at www.pnas.org/content/early/ 2010/01/20/0914500107.abstract.


Merck & Co. has provided U.S. regulators with new information needed for approval to market its Gardasil cervical cancer vaccine to women between the ages of 27 and 45. Gardasil was approved in 2006 for preventing cervical cancer and genital warts in females between ages 9 and 26.


An inhalable measles vaccine called carbon dioxide assisted nebulization has been developed by researchers at the University of Colorado. Trials in animals have been successful, and human trials, to be conducted in Pune, India, will be conducted in three phases.


Researchers at the Cleveland Clinic have had positive results in tests on a new vaccine that could be used to protect against breast cancer. The vaccine works by forcing the immune system to tackle a protein found in breast cancer cells and the mammary tissue of women who are breastfeeding. In the study, half of the genetically cancer-prone mice that were vaccinated with a-lactalbumin failed to develop breast cancer, while the other half that were administered a vaccine without the antigen all developed breast cancer. Human trials are planned.


The U.S. Food and Drug Administration has granted orphan drug status to BioSante Pharmaceuticals’ experimental cancer vaccine called GVAX CML for the treatment of chronic myeloid leukemia. This is the company’s third vaccine to get orphan designation after pancreatic cancer and acute myeloid leukemia vaccines.

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.