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

NCT04957485 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-02

No results posted yet for this 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

Interventions

DRUG

Tecovirimat

oral antiviral

DRUG

Smallpox and Mpox Vaccine

vaccine

OTHER

Placebo

TPOXX Placebo

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • SIGA Technologies

    lead INDUSTRY

Principal Investigators

  • Dennis Hruby, Ph.D. · SIGA Technologies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04957485 on ClinicalTrials.gov