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

Exclusion criteria

• . Subject is a female who is pregnant or breastfeeding or planning to become pregnant within 3 months after the second JYNNEOS injection.
• . Subject has a history or suspected exposure of smallpox, monkeypox or cowpox disease, or previous vaccination with any poxvirus-based vaccine.
• . Subject has received any vaccinations within 28 days prior to Day 1 or plans to receive a vaccination at any time during the treatment period or within 28 days after Day 29.
• . Subject weighs 120 kg or more.
• . Subject has been administered or plans to be administered immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at trial conclusion.
• . Subject has used any investigational or nonregistered drug or vaccine other than the trial vaccines within 28 days preceding the first dose of the trial vaccine or planned administration of such a drug /vaccine during the trial period, including the COVID-19 vaccine prior to marketing approval by the FDA.
• . Subject has a known or suspected history of smallpox vaccination defined as visible vaccination scar or documentation of smallpox vaccination or as reported by the subject.
• . Subject has had a previous anaphylactic reaction, severe systemic response, or serious hypersensitivity to a prior immunization.