Abstract
PurposeCOVID-19 as a pandemic calls for rapid development of vaccines.MethodsHere a proposal of a seamless, adaptive, phase 1–3 trial for accelerated vaccine development is described.ResultsStarting at 10, the number of vaccinated volunteers would exponentially increase by tenfold at an interval of 2 weeks; close surveillance of antibody responses, safety and efficacy is necessary. After only 16 weeks, general vaccination would be feasible if supply meets the demand.ConclusionA COVID-19 vaccine would be rapidly available at a slightly increased risk for undetected late side effects or insufficient efficacy if compared with standard vaccine development schemes.
Highlights
Some accelerated testing schemes have been suggested in recent weeks [1], but as a clinical pharmacologist engaged in translational medicine and in the design of smart early clinical trials [2], I would like to propose an even more radical deviation from normal standards
I suggest exponential exposure starting with 10 healthy volunteers, testing of antibody responses and safety after 14 days; if no stoppers [lack of adequate antibody response, intolerable side effects] occur, the number of vaccinated people will be increased by tenfold in each subsequent step, in this case to the cohort of 100 people
Vaccination efficacy must be monitored in parallel; ideally, the early stages of the study should be placed in countries with low risk of infection
Summary
COVID-19 is a pandemic that may kill millions of people. Some accelerated testing schemes have been suggested in recent weeks [1], but as a clinical pharmacologist engaged in translational medicine and in the design of smart early clinical trials [2], I would like to propose an even more radical deviation from normal standards. The pre-requisite for human trials of a vaccine is its successful testing in animals with three major goals: The original online version of this article was revised due to a retrospective Open Access order.
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