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Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04957485

Public ClinicalTrials.gov record NCT04957485. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 1:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT04957485
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
SIGA Technologies
Industry
Enrollment
100 participants

Conditions and interventions

Conditions

Interventions

  • Tecovirimat Drug
  • Smallpox and Mpox Vaccine Drug
  • Placebo Other

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 42 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 4, 2022
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026
Last update posted
Apr 1, 2026

2022 – 2027

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Meridian Clinical Research Omaha Nebraska 68134-3664
Aventiv Research Inc Columbus Ohio 43213-6510

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04957485, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 1, 2026 · Synced Jul 23, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04957485 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →