This is a Phase 2, open-label (JYNNEOS), double-blind (TPOXX and placebo), multicenter, randomized, placebo-controlled, drug-vaccine interaction study to examine whether administering TPOXX with JYNNEOS concomitantly affects JYNNEOS immunogenicity in healthy adult subjects. A total of 100 subjects (approximately 50 subjects per treatment group), ages 18 to 42, inclusive, will be enrolled and randomly assigned to 1 of 2 treatment groups.
This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are administered subcutaneously (SC) 4 weeks apart; and potential immunological interference while concomitantly administering TPOXX or placebo orally twice daily (BID) for 28 days.