Vical opens phase 2 trial of DNA vaccine against cytomegalovirus

By Lisa Kerner

Erie, Pa., Feb. 1 - Vical Inc. said it has opened enrollment in its novel phase 2 trial of a DNA vaccine against cytomegalovirus (CMV), a herpes virus.

The phase 2 trial will be conducted at U.S. transplant centers in donors and patients undergoing stem cell transplants, according to a company news release.

Both donors and recipients will be vaccinated in the double-blind, placebo-controlled phase 2 trial. Safety of the vaccine will be compared against placebo in about 80 matched, related donor/recipient pairs (160 subjects total).

Study endpoints are the immune responses against the specific CMV features targeted by the vaccine, and the occurrence rate of CMV levels in patients receiving active vaccine compared with patients receiving placebo.

The company said that success in the phase 2 study patient population would support expansion of CMV vaccine studies into other transplant settings and into the general population.

"Results from phase 1 trials indicate that our CMV DNA vaccine can induce both cellular and antibody immune responses. This small phase 2 trial will allow us to evaluate quickly the protective efficacy of our vaccine in a patient population subject to natural viral challenge," David C. Kaslow, Vical's chief scientific officer, said in the release.

Vical's novel DNA vaccine approach is designed to induce both antibody and cellular immune responses against specific features of the CMV virus without the risk of causing CMV disease. The company's CMV vaccine has received Orphan Drug designation by the Food and Drug Administration for at-risk stem cell transplant and solid organ transplant populations.

In addition, Vical has been awarded $4.1 million in funding for its CMV vaccine program under three grants from the National Institutes of Health.

San Diego-based Vical develops biopharmaceutical products using its patented DNA delivery technologies.

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