CMV bivalent vaccine: Final Phase II data

Final data from a double-blind, U.S. Phase II trial in 74 CMV-seropositive hematopoietic stem cell transplant recipients showed that TransVax significantly increased T cell responses to phosphoprotein 65 CMV antigen at 1 year post-transplant vs. placebo (p=0.003), but non-significantly increased T cell responses to glycoprotein B CMV antigen (p=0.075). TransVax also significantly reduced the incidence of CMV viremia (32% vs. 62%, p=0.008) and the number of CMV viremia episodes (p=0.017) at 1 year post-transplant vs. placebo, but non-significantly reduced the mean duration of viremia vs. placebo (10.6 vs. 19.5 days, p=0.069). Median time to initial viremia was significantly longer for TransVax vs. placebo (>365 vs. 109.5 days, p=0.003), and 48% of TransVax-treated patients required treatment for CMV infection vs. 62% for placebo (p=0.145).

The vaccine was well tolerated with no significant difference in the number of serious adverse events reported between treatment groups. There were also fewer deaths in the TransVax group vs. placebo (18% vs. 32%). Data were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in Boston. ...