Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this trial:
• •1. For female participants: Pregnancy or breastfeeding
• •2. Acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of responses, including but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immunosuppressive conditions
• •3. History of or active autoimmune disease (vitiligo or thyroid disease requiring thyroid replacement are not exclusions), history of Guillain-Barré syndrome or Reye's syndrome
• •4. Known immunodeficiency syndrome or known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, or moderate to severe kidney impairment. Human immunodeficiency virus (HIV) infection under stable Highly active antiretroviral therapy (HAART) (no change within the last three month) and CD4 count \>500/ µL is not considered immunodeficient
• •5. Known or reported previous smallpox vaccination, or vaccination with any licensed or investigational poxvirus-based vaccine
• •6. History of monkeypox, cowpox, or vaccinia infection
• •7. Close contact in the 3 weeks prior to signing the ICF with anyone known to have mpox
• •8. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure
• •9. Clinically significant mental disorder not adequately controlled by medical treatment
• •10. Active or recent (within 6 months before screening) chronic alcohol abuse and/or intravenous and/or nasal drug abuse
• •11. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, eg, tris(hydroxymethyl)-amino methane, including history of allergic asthma
• •12. Known allergy to aminoglycosides or quinolones
• •13. History of anaphylaxis of severe allergic reaction to any vaccine
• •14. Receipt of or plans to receive any licensed live vaccine from 30 days prior to the trial vaccination until 30 days after vaccination
• •15. Receipt of or plans to receive any licensed nonlive vaccine from 14 days prior to the trial vaccination until 14 days after last trial vaccination
• •16. Use of any investigational or nonregistered agent within 30 days prior to vaccination or plans to receive an investigational agent during the trial
• •17. Recent blood donation (including platelets, plasma, and red blood cells) within 4 weeks prior to screening or planned blood donations during the active trial period
• •18. Chronic systemic administration (defined as more than 14 days) of \>5 mg prednisone (or equivalent)/day or any other immune-modifying drugs from 3 months prior to the first trial vaccination to the visit at the end of the active trial period (use of topical, inhaled, ophthalmic, and nasal glucocorticoids is allowed)
• •19. History of organ transplantation, whether or not chronic immunosuppressive therapy. is being administered
• •20. Administration or planned administration of immunoglobulins and/or any blood products from 3 months prior to the first trial vaccination until the visit at the end of the active trial period (packed red blood cells given for an emergency indication in an otherwise healthy person and not required as ongoing treatment is not exclusionary \[eg, packed red blood cells given in an emergency during elective surgery\])
• •21. History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, significant arrhythmia with or without corrective/ablative surgery, or any other heart condition under the care of a doctor
• •22. Employment with the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or relationship to the investigator or study site employee
• •23. Relationship with Bavarian Nordic as an employee or employee family member, contractor, agent, or business partner or a financial interest in the outcome of the trial
• •Pediatric Cohort
• •A child who meets any of the following criteria will be excluded from participation in this trial:
• •1. Acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of responses, including but not limited to, neurologic, cardiovascular, respiratory, hepatic, hematologic, rheumatologic, endocrine, gastrointestinal, renal, autoimmune, or immunosuppressive conditions
• •2. History of or currently active autoimmune disease (vitiligo or thyroid disease requiring thyroid replacement therapy are not exclusions), history of Guillain-Barré syndrome or Reye's syndrome
• •3. Known immunodeficiency syndrome. or known or suspected impairment of immunologic functions including, but not limited to, clinically significant liver disease, diabetes mellitus type I, or moderate to severe kidney impairment. HIV infection under stable HAART (no change within the last three month) and CD4 count \>500/ µL is not considered immunodeficient
• •4. Known or reported previous smallpox vaccination or vaccination with any licensed or investigational poxvirus-based vaccine
• •5. History of monkeypox, cowpox, or vaccina infection
• •6. Close contact in the 3 weeks prior to signing the ICF/assent form with anyone known to have mpox
• •7. History of malignancy (eg, leukemia or lymphoma)
• •8. History of chronic or known neurological disease or deficient development history
• •9. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including history of allergic asthma
• •10. Known allergy to aminoglycosides or quinolones
• •11. History of anaphylaxis or severe allergic reaction to any vaccine
• •12. Receipt of or plans to receive any licensed live vaccine from 30 days prior to first trial vaccination until 30 days after last trial vaccination
• •13. Receipt of or plans to receive any licensed nonlive vaccine from 14 days prior to first trial vaccination until 14 days after last trial vaccination
• •14. Use of any investigational or nonregistered agent other than the trial vaccine within 30 days prior to first vaccination or plans to receive an investigational agent during the trial period
• •15. Chronic administration (defined as more than 14 days) of systemic high dose immune suppressant drugs (2 mg/kg/day or more of prednisolone or its equivalent or 20 mg/day or more for children who weigh more than 10 kg) from 6 months prior to first trial vaccination to trial conclusion
• •16. History of organ transplantation, whether or not chronic immunosuppressive therapy. is being administered
• •17. Administration or planned administration of immunoglobulins and/or any blood products from 3 months prior to the first trial vaccination until the visit at the end of the active trial period
• •18. Employment of parent/guardian with the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or relationship to the investigator or study site employee
• •19. Relationship of parent/guardian with Bavarian Nordic as an employee or employee family member, contractor, agent, or business partner or a financial interest in the outcome of the trial