A recent clinical trial conducted by Gary D. Steinberg, MD sought to investigate the HS-410 vaccine as a possible adjunct to BCG therapy when treating patients with bladder cancer. The HS-410 vaccine is a cell line specifically selected for this study because of its cross-reactivity with known bladder cancer antigens. The vaccine cell line was further modified via addition of the GP-96 gene to help enhance the immune response generated by the patient.
The study involved 4 separate arms: BCG plus placebo, BCG plus low-dose vaccine, BCG plus high-dose vaccine, and vaccine alone (reserved for patients with known intolerance to BCG). All patients received maintenance therapy and the main outcome investigated was disease-free survival rate after 1-year of continuous treatment. The results of the study did not show a significant difference between the BCG alone and BCG plus vaccine arms, but they did, however, perform better than historical controls. More importantly, the study did find that treatment with BCG plus vaccine elicited an increased immune response in the form of T-cell priming when compared to treatment with BCG alone.