🏛️ Verified NIH Record • Updated 2026-03-27

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS (NCT04957485)

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

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: SIGA Technologies

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Meridian Clinical Research — Omaha, Nebraska

Age range: 18 Years to 42 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (2 Sites)

  • Meridian Clinical Research — Omaha, Nebraska
  • Aventiv Research Inc — Columbus, Ohio

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Smallpox clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗