Study: NCT01580696

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster
Description: 100mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.~Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Non-vaccine clinically matched control group
Description: HLA-A2-negative patients or HLA-A2-positive patients who decline the vaccine will be followed clinically as matched controls for disease recurrence/progression. No experimental treatment will be administered to this group.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster
Description: 500mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.~Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster
Description: 1000mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.~Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster
Description: 100mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.~Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: E39 peptide (500mcg)/GM-CSF vaccine plus J65 booster
Description: 500mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.~Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: E39 peptide (1000mcg)/GM-CSF vaccine plus J65 booster
Description: 1000mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.~Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above.