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Virus Vaccine

JYNNEOS + TPOXX for Smallpox

Phase 2
Waitlist Available
Research Sponsored by SIGA Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a resting heart rate >40 beats per minute (bpm) or <110 bpm at screening.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 43
Awards & highlights

Study Summary

This trial will study whether two doses of Jynneos given four weeks apart can create an immunity response, and whether taking Tpoxx or placebo orally twice a day for 28 days interferes with this response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your heart rate is between 40 and 110 beats per minute while resting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 43
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 43 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMT of vaccinia virus neutralizing antibodies
Secondary outcome measures
Incidence of treatment-emergent adverse events

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: JYNNEOS + TPOXXActive Control1 Intervention
An oral dose of 600 mg (3 × 200 mg capsules) TPOXX BID (every 12 hours [±30 minutes]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX concomitantly on Day 1
Group II: JYNNEOS + matching TPOXX placeboPlacebo Group1 Intervention
An oral dose of placebo (3 capsules identical to TPOXX) BID (every 12 hours [±30 minutes]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX placebo concomitantly on Day 1.

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Who is running the clinical trial?

SIGA TechnologiesLead Sponsor
10 Previous Clinical Trials
1,673 Total Patients Enrolled
6 Trials studying Smallpox
1,006 Patients Enrolled for Smallpox
United States Department of DefenseFED
856 Previous Clinical Trials
225,495 Total Patients Enrolled
1 Trials studying Smallpox
467 Patients Enrolled for Smallpox
Dennis Hruby, Ph.D.Study DirectorSIGA Technologies
1 Previous Clinical Trials
449 Total Patients Enrolled
1 Trials studying Smallpox
449 Patients Enrolled for Smallpox

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity for this experiment?

"Affirmative. The data hosted on clinicaltrials.gov attests that this research is currently seeking participants, as it was initially posted on the 5th of January 2022 and updated lastly 10/6/2022. A total of 100 individuals are required between 2 different medical centres for the trial to take place."

Answered by AI

Have other experiments featured the combination of JYNNEOS and TPOXX?

"Currently, 3 trials for the combination of JYNNEOS and TPOXX are being conducted with 1 at Phase 3. Most studies take place in Omaha, Nebraska, though 12 other sites are running tests as well."

Answered by AI

Are there any hazardous risks associated with using JYNNEOS + TPOXX?

"The safety of JYNNEOS + TPOXX has been rated a 2 on the risk-assessment scale. This is due to Phase 2 trial data confirming basic safety, though there are presently no verifications that it can be effective in treating symptoms."

Answered by AI

Is this an unprecedented research endeavor?

"Since 2022, SIGA Technologies have been researching JYNNEOS + TPOXX. This medicinal combination was granted Phase 2 approval following a 100 person trial in the same year, and since then three separate studies are occurring across nine cities and one nation."

Answered by AI

Does this experiment include participants who are over two decades old?

"This clinical research is seeking subjects aged between 18 and 42 years old."

Answered by AI

Is this trial currently open to participants?

"Affirmative. Clinicaltrials.gov documents reveal that this clinical study, which was first posted on May 1st 2022, is still seeking participants. Approximately 100 subjects need to be enrolled from two distinct medical centers."

Answered by AI

Would I fulfill the requirements to join this research study?

"This trial seeks 100 healthy adults between 18 and 42 years of age who have been diagnosed with smallpox. In addition to this, potential participants must possess a resting heart rate above 40 beats per minute or below 110 bpm; be HIV antibody-, hepatitis b surface antigen- and hepatitis c virus antibody negative; have white blood cells ranging from 2500/mm3 to 11 000/mm3; hemoglobin within normal limits; platelets at or greater than the lower reference range for laboratory results; calculated creatinine clearance over 60 mL/min as estimated by the Cockcroft-Gault equation; creatinine in males ≤1.7"

Answered by AI
~32 spots leftby Mar 2025