Vaccine Update

Preclinical testing of a DNA synthetic vaccine by Inovio Pharmaceuticals Inc. for the virulent Middle East respiratory syndrome (MERS) coronavirus induced robust and durable immune responses, demonstrating the potential for a SynCon(R) DNA vaccine to prevent and treat this deadly virus. Since 2012, when the virus was first identified, 153 cases from nine Middle Eastern countries have been reported, and 42 percent of these cases have been fatal. MERS is similar to the SARS virus that infected 8,000 people several years ago. MERS differs from SARS in that it appears to be less contagious, but MERS is almost five times as fatal as SARS, which killed 10 percent of those infected. There is no vaccine or effective treatment for MERS.

Loyola University Medical Center is setting up a clinical trial for an experimental vaccine that trains a patient’s immune system to fight melanoma. The process involves removing a batch of the immune system’s killer T cells from the patient and modifying them in a lab. Two genes are inserted into the extracted cells so that they can recognize tumor cells as abnormal. The patient undergoes high-dose chemotherapy to kill most of the remaining T cells, to make room for the genetically modified T cells when they are put back in the patient. The modified T cells, it is hoped, will recognize the tumor cells as abnormal and then attack and kill them. In the trial, four doses will be tested, with the highest dose consisting of five billion genetically modified T cells. If the trial demonstrates the treatment is safe, scientists will proceed to the second part of the trial, which will determine if the treatment is effective.

The U.S. Food and Drug Administration has approved the first adjuvanted vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, for the prevention of H5N1 influenza in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. The vaccine is made using an egg-based manufacturing process and contains the adjuvant AS03, an oil-in-water emulsion. The H5N1 component and the AS03 adjuvant component are supplied in two separate vials, which must be combined prior to use. The vaccine is administered via intramuscular injection in two doses, 21 days apart. It is not intended for commercial availability. Instead, the U.S. Department of Health and Human Services has purchased the vaccine from the manufacturer, ID Biomedical Corp. of Quebec, Quebec City, Canada (a subsidiary of Glaxo SmithKline Biologicals), for inclusion within the National Stockpile for distribution by public health officials if needed.