https://www.statnews.com/2022/08/04/with-monkeypox-vaccine-in-high-demand-nih-to-test-approaches-to-stretch-supplies/?utm_source=STAT+Newsletters&utm_campaign=c7202d5043-MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-c7202d5043-154451064

Scientists at the National Institutes of Health are [...] putting the finishing touches on the design of a clinical trial to assess two methods of stretching available doses of Jynneos, the only vaccine in the United States approved for vaccination against monkeypox.

Beigel, who described the study earlier this week during a meeting organized by the World Health Organization to flesh out the research needed on monkeypox vaccine, said in an interview that the plan is to enroll 210 people in this three-arm trial. The study will be conducted over six to eight trial sites in the U.S., he said, and will start later this month or in the first half of September.

One-third of the subjects, the comparator arm, will receive two full doses of Jynneos given 28 days apart. A second group will get a single full dose of vaccine. The third group will also get two doses, given 28 days apart. But these doses will each be one-fifth of a full dose and the vaccine will be administered into the skin — intradermally — rather than into a muscle.

The study will not evaluate how protective the various regimens are. To generate vaccine efficacy estimates, much larger clinical trials involving thousands of participants would need to be conducted. Instead, the goal will be to study whether the two dose-sparing approaches generated antibody levels at least equal to what the two-dose regimen does.

Will two one-fifth sized doses generate antibody levels at least 50% of what two full dosage do?

Small print: Forget about statistical significance; this question resolves according to the point estimate of the mean of the antibody levels.

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