JYNNEOS + TPOXX for Smallpox

Phase-Based Progress Estimates
Meridian Clinical Research, Omaha, NESmallpoxJYNNEOS + TPOXX - Biological
18 - 42
All Sexes
What conditions do you have?

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.

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Day 43

30 days
Incidence of treatment-emergent adverse events
Day 43
GMT of vaccinia virus neutralizing antibodies

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

1 of 2
JYNNEOS + matching TPOXX placebo
1 of 2

Active Control

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: JYNNEOS + TPOXX · Has Placebo Group · Phase 2

JYNNEOS + matching TPOXX placebo
PlaceboComparator Group · 1 Intervention: JYNNEOS + TPOXX PLACEBO · Intervention Types: Biological
ActiveComparator Group · 1 Intervention: JYNNEOS + TPOXX · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 43

Who is running the clinical trial?

United States Department of DefenseFED
790 Previous Clinical Trials
202,623 Total Patients Enrolled
1 Trials studying Smallpox
445 Patients Enrolled for Smallpox
SIGA TechnologiesLead Sponsor
10 Previous Clinical Trials
1,651 Total Patients Enrolled
6 Trials studying Smallpox
984 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

Eligibility Criteria

Age 18 - 42 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a healthy person between the ages of 18 and 42 years old when you agree to participate in the study.
Your heart rate is between 40 and 110 beats per minute while resting.
You do not have HIV, hepatitis B, or hepatitis C.
Your platelet count is not too low.
Your white blood cell count is between 2500 and 11,000 cells per milliliter of blood.
Your hemoglobin levels are normal.
Your kidney function, as measured by a test called creatinine clearance, is good (above 60 mL/min).
Your creatinine levels are within the normal range for your gender (less than a certain value).
Your bilirubin level is within the normal range.
Your liver function test (ALT) must be within the normal range or slightly elevated.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"This clinical research is seeking subjects aged between 18 and 42 years old." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.