The phase II trial will be conducted at US transplant centers in donors and patients undergoing stem cell transplants. Success in this patient population would support Vical’s expansion of studies of its cytomegalovirus (CMV) vaccine into other transplant settings and into the general population.
While a healthy immune system typically protects an infected person against CMV disease, it rarely succeeds in completely eliminating the infection, and those whose immune systems are not fully functional are at high risk of CMV proliferation, potentially leading to severe illness or death.
Because there currently is no approved CMV vaccine, Vical’s vaccine has received orphan drug designation from the FDA for at-risk stem cell transplant and solid organ transplant populations. The company also has been awarded $4.1 million in funding for the program under three grants from the NIH.
“The emerging picture from a series of studies suggests that DNA vaccines effectively prepare the immune system for subsequent infection,” said Dr David Kaslow, Vical’s chief scientific officer. “This small phase II trial will allow us to evaluate quickly the protective efficacy of our vaccine in a patient population subject to natural viral challenge.”