Tecovirimat + Smallpox Vaccine 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 59 days

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.

Who is the study for?

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.

What is being tested?

The trial is testing how well a smallpox vaccine (JYNNEOS) works when given alongside an oral medication (TPOXX) or placebo for 28 days. Participants will receive two doses of JYNNEOS via injection four weeks apart while taking TPOXX/placebo twice daily.

What are the potential side effects?

Potential side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fatigue, headache, muscle pain, nausea and potential allergic reactions to components in TPOXX® or JYNNEOS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 59 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~59 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 59 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

Immunogenicity

Secondary study objectives

Incidence of treatment-emergent adverse events

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: JYNNEOS + TPOXXActive Control2 Interventions

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 Group2 Interventions

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.

Do I qualify?Apply below to find out