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NCT04957485 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
A Phase 2 study of Smallpox, sponsored by SIGA Technologies.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT04957485 is a Phase 2 study of Smallpox that is active but no longer recruiting, run by SIGA Technologies. The registered enrollment target is 100 participants, below the 131,037-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04957485, a Phase 2 study of Smallpox, is active but no longer recruiting, sponsored by SIGA Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Tecovirimat
- DRUG Smallpox and Mpox Vaccine
Study Locations (2)
Nebraska
- Meridian Clinical Research - Omaha
Ohio
- Aventiv Research Inc - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-04-05 |
| Est. Completion | 2026-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04957485
The ClinicalTrials.gov registry entry for NCT04957485 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 131,037-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower). The listed sponsor is SIGA Technologies, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04957485 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Nebraska, Ohio.
Frequently Asked Questions
What is clinical trial NCT04957485 about?
NCT04957485 is a clinical study titled "Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS". 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.
What is the current status of trial NCT04957485?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-04-05. Estimated completion is 2026-01-01.
What conditions does trial NCT04957485 study?
This clinical trial studies the following conditions: Smallpox.
What interventions are being tested in trial NCT04957485?
The interventions under investigation include: Placebo (OTHER), Tecovirimat (DRUG), Smallpox and Mpox Vaccine (DRUG).
Who is sponsoring clinical trial NCT04957485?
This trial is sponsored by SIGA Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04957485 being conducted?
This trial has 2 study locations across Nebraska, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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