Tecovirimat + Smallpox Vaccine for Smallpox
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, certain medications are prohibited within 14 days before the first vaccine injection, including some antidiabetic, anticoagulant, and anticonvulsant drugs, among others. It's best to discuss your current medications with the study team to see if they are allowed.
What data supports the effectiveness of the drug Tecovirimat (TPOXX) for treating smallpox?
Tecovirimat has been shown to be effective in preventing lethal orthopoxviral disease in animal models, and all tecovirimat-treated animals survived smallpox infection in studies, suggesting it is likely to benefit humans with smallpox. Additionally, it was approved by the FDA based on its efficacy in animal models.12345
How is the drug Tecovirimat + Smallpox Vaccine unique for treating smallpox?
Tecovirimat (TPOXX) is unique because it specifically targets the orthopoxvirus VP37 protein, preventing the virus from spreading in the body, and is approved for smallpox treatment based on animal studies. This combination with the JYNNEOS vaccine offers a novel approach by pairing an antiviral drug with a vaccine to enhance protection against smallpox.25678
Research Team
Dennis Hruby, Ph.D.
Principal Investigator
SIGA Technologies
Eligibility Criteria
Healthy men and women aged 18-42, with normal heart rate, blood cell counts, kidney and liver function. Must not be pregnant or breastfeeding, agree to use contraception or abstain from sex during the study. Cannot have significant allergies or medical conditions that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive JYNNEOS subcutaneously on Day 1 and Day 29, and TPOXX or placebo orally twice daily for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- JYNNEOS
- TPOXX
Find a Clinic Near You
Who Is Running the Clinical Trial?
SIGA Technologies
Lead Sponsor
United States Department of Defense
Collaborator