Vaccine Phase I Design with Simultaneous Evaluation of
Immunogenicity and Toxicity
Description
Phase I clinical trials are the first step in drug development to test
a new drug or drug combination on humans. Typical designs of Phase I
trials use toxicity as the primary endpoint and aim to find the maximum
tolerable dosage. However, these designs are poorly applicable for the
development of cancer therapeutic vaccines because the expected safety
concerns for these vaccines are not as much as cytotoxic agents. The
primary objectives of a cancer therapeutic vaccine phase I trial thus
often include determining whether the vaccine shows biologic activity
and the minimum dose necessary to achieve a full immune or even clinical
response. This package implements a Bayesian Phase I cancer vaccine
trial design that allows simultaneous evaluation of safety and
immunogenicity outcomes. See Wang et al. (2019)
for further details.