A phase II trial comparing five dose levels of BEC2 anti-idiotypic monoclonal antibody vaccine that mimics GD3 ganglioside.

In previous studies, we showed that immunization with 2.5 mg of BEC2, an anti-idiotypic MAb that mimics GD3 ganglioside, can induce antibodies against GD3 in approximately 25% of patients. In this trial, 50 melanoma patients at high risk for recurrence were randomly assigned to one of the five BEC2 dose levels (2.5 microg-10mg) to determine if lower or higher BEC2 doses are more immunogenic. We also tested whether prolonged booster immunizations can enhance the anti-GD3 antibody response. All patients developed detectable IgG against BEC2 except for one patient at the lowest BEC2 dose level. Six patients developed detectable antibody responses to GD3, all of them at the lower three dose levels of BEC2. We conclude that high doses of BEC2 are not necessary to induce anti-GD3 antibody responses and that lower doses may be more immunogenic than the 2.5 mg dose used in previous BEC2 trials. Prolonged booster immunizations did not induce or maintain antibody responses.

RCT Entities:   Population Interventions Outcomes