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Issues to Consider: Vaccination of Solid Organ Transplant Patients
| Vaccine or placebo should be given pretransplant |
| No immunusuppressive drugs at that time |
| The trial cannot control who gets transplanted or when |
| Some never transplanted, so increase sample size |
| Use a pharmacodynamic readout posttransplant |
| Reduction in parameters of viral load |
| Seek an immune correlate of protection |
| Compare passive administration of correlate with placebo |
| Monoclonal antibody or T cells |
