NCT04957485

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

A Phase 1, Open-Label (JYNNEOS®), Double-Blind (TPOXX® And Placebo), Multicenter, Randomized, Placebo-Controlled, Drug-Vaccine Interaction Study To Evaluate the Impact of TPOXX on JYNNEOS Immunogenicity

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: SIGA Technologies · Industry
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Smallpox

Interventions

Type	Name	Description
DRUG	Tecovirimat	oral antiviral
DRUG	Smallpox and Mpox Vaccine	vaccine
OTHER	Placebo	TPOXX Placebo

Timeline

• Start date: 2022-04-05
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2021-07-12
• Last updated: 2026-04-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study