10. Dose modifications There will not be any modifications to doses. There may be allo wances for the timing of the administration of vaccine to accommodate patient schedules or special circumstances. For example, if a subject has an acute viral illness, the administration of their vaccination may be delayed by as much as 3 weeks. Such var iations in the timing of monthly vaccinations will be decided by the Principle Investigator on a case -by-case basis. Subsequent vaccinations will be scheduled 30 days from when the previous vaccine was actually administered, not when it should have been ad ministered. 11. Accrual and criteria for premature study termination Accrual will be terminated if dose limiting toxicity (DLT) is observed. DLT is defined as a 5% incidence of grade 4 toxicity or a 15% incidence of grade 2 allergy >48 hours or grade 3 or worse toxicity. Operationally, the 5th subject enrolled will be a minimum of 1 month from their last vaccination and will be evaluated for toxicity with no DLT before further accrual of the next 15 patients. Stopping rules will become operational if e vidence suggests that the true toxicity rate exceeds 5% Grade 4 or 15% Grade 3 toxicity, where sufficient evidence will be taken to be observed rates of toxicity that correspond to one-sided 80% confidence intervals with lower limits greater than 5% or 15% , respectively. Thus, an incidence of Grade 4 toxicity in 1/4 or 2/15 subjects or Grade 3 or worse toxicity in 1/1, 2/5, 3/10 or 4/15 subjects would constitute sufficient evidence that the toxicity rates exceed 5% Grade 4 or 15% Grade 3 toxicity. Tables 2 and 3 summarize the operating characteristics of these stopping rules, where the probability of stopping the study is estimated from 5,000 Monte Carlo simulations. 6304p Protocol 118 04/06/2016 Table 2. Probability of Stopping Trial for Grade 4 Toxicity Number of Patients True R ate of Event Probability of Stopping 5 15% 0.39 10 15% 0.55 15 15% 0.72 5 25% 0.61 10 25% 0.81 15 25% 0.93 Table 3. Probability of Stopping Trial for Grade 3 or Worse Toxicity Number of Patients True Rate of Event Probability of Stopping 5 5% 0.02 10 5% 0.03 15 5% 0.03 5 25% 0.37 10 25% 0.54 15 25% 0.64 5 35% 0.56 10 35% 0.77 15 35% 0.87 12. Evaluation of immune response (see Appendix B) 13.