Either i. High-risk disease, defined as T1 and/or high-grade and/or CIS, or ii. Intermediate-risk disease defined as Ta low-grade with at least three of the following four risk factors: multiple tumors, tumor size > 3cm, early recurrence (<1 year from previous staging procedure), or recurrence with a frequency of more than once in any 12 month period. 4. Patients must be BCG naive or have completed previous BCG treatment >12 months prior to the baseline staging procedure. 5. For Phase 2 only: Arms 1, 2, and 3: Suitable, in the opinion of the investigator, to receive a 6- week course of induction intravesical BCG in the adjuvant setting within 6 weeks following the baseline staging procedure for the current occurrence of non-muscle invasive bladder cancer. Arm 4: Suitable for monotherapy vaccine administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG. 6.