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Vaccine Phase I Design with Simultaneous Evaluation of Immunogenicity and Toxicity

Gary L Rosner, Richard B.s. Roden, Chenguang Wang, Zilu Wang

Last update: 9 August 2023

Copyright license: GNU General Public License

Software version identifier: 2.1, 2.2

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) <doi:10.1002/sim.8021> for further details.

Cites work

A Bayesian design for phase I cancer therapeutic vaccine trials

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