drugset / Trial / NCT04957485
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
Phase 2
Active not recruiting
100 enrolled
SIGA Technologies
United States Department of Defense · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2022-04-05
- Primary completion
- 2027-01-01
- Completion
- 2027-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Smallpox and Mpox Vaccine | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | Tecovirimat | Small molecule | 600 mg | Oral |