> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-multicenter-immunogenicity-and-safety-study-of-677f3bde-56ae-4166-a6b7-183587d929d8 > Record changed: 2026-11-04 # 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 NCT06549530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) Participants 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) Lead sponsor Bavarian Nordic Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) Start date 2024-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) Number of sites 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Title and summary **Summary** All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen). Serum samples for assessment of immune response will be collected at baseline (visit of first vaccination) and at 2 weeks (week 6), 6 months (week 30), and 1 year after the second (last) vaccination. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Dates **Completion date** 2026-05-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **First posted** 2024-08-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Registry last updated** 2025-11-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Primary completion date** 2026-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Start date** 2024-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Size and sites **Participants** 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Planned participants** 460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Number of sites** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Lead sponsor** Bavarian Nordic Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Identifiers **Registry ID** NCT06549530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **ClinicalTrials.gov ID** NCT06549530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Outcomes ### Primary outcomes 1. Immunogenicity of 2 doses of MVA BN Timeframe: 2 weeks after the second MVA-BN vaccination Titer of serum neutralizing antibodies against vaccinia virus as measured by plaque reduction neutralization tests (PRNTs) 2 weeks after the second MVA BN vaccination 2. Occurrence of Safety Adverse Events (SAE) & Adverse of Event of Special Interest (AESI) events Timeframe: Day 0 to week 56 Occurrence of any SAE at any time during the trial period Occurrence of any AESI at any time during the trial period ### Secondary outcomes 1. Neutralizing antibody response Timeframe: From day zero to two weeks after the second vaccination To assess neutralizing antibody response to the MVABN standard regimen 2. Neutralizing antibody response durability Timeframe: Six months and one year after the second vaccination To assess durability of neutralizing antibody response to the MVABN standard regimen Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Eligibility **Sex** All **Age groups** Children, Adults **Minimum age** 2 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria To be eligible to participate in this trial, an adult individual must meet all the following criteria: 1. Age 18 to 50 years at screening 2. Male or female sex 3. Informed consent form (ICF) signed and dated by the participant after reading the form and being advised of the risks and benefits of the trial in a language understood by the participant and before performance of any trial-specific procedures 4. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator 5. Body mass index (BMI) ≥18.5 and ≤35 (calculated as \[body weight in kilograms\] /\[body height in meters\] 2) 6. Agreement by female participants of childbearing potential and male participants who are sexually active with a female partner of childbearing potential to use a highly effective method of birth control from at least 30 days prior to administration of the MVA-BN vaccine until 30 days after last vaccination 1. Medically acceptable methods of contraception that may be used by the participant and/or partner include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone releasing system (IUS), bilateral tubal occlusion, vasectomy, or abstinence (abstinence only acceptable if refraining from heterosexual intercourse during the entire period of 30 days prior to administration of the MVA-BN vaccine until 30 days after last vaccination). 2. Female participants or partners are not considered to be of childbearing potential if they are at least 1 year post-menopausal (amenorrhea >12 months and follicle stimulating hormone according to local lab values) at screening. 7. Willingness to comply with the requirements of the protocol, in the judgment of the investigator Pediatric Cohort To be eligible to participate in this trial, a child must meet all the following criteria: 1. Age ≥2 and <12 years at screening 2. Male or female sex 3. Informed consent form signed and dated by a parent/guardian after reading the form and being advised of the risks and benefits or the trial in a language understood by the parent/guardian and before performance of any trial-specific procedures 4. Assent form signed and dated, for children required by local regulations 1. provide consent ≥8 years of age enrolled at sites in Uganda 2. children deemed by the investigator and/or local regulations to be capable of assent in Democratic Republic of Congo 5. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator 6. Willingness of parent/guardian to comply with the requirements of the protocol, in the judgment of the investigator ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Sites - University of KinshasaKinshasa, Democratic Republic of the Congo - Uganda Virus Research InstituteEntebbe, Uganda - Epicentre Mbarara Research CentreMbarara, Uganda Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## References - PubMed 42372625 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42372625/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06549530) ## Related records ### Drugs (1) - [Vaccinia virus modified strain ankara-bavarian nordic non-replicating antigen](https://trialight.com/data/asset/vaccinia-virus-modified-strain-ankara-bavarian-nordic-non-34a66f24-6cfe-5780-92a2-6a8bb1f52258.md) ### Collaborators (1) - Coalition for Epidemic Preparedness Innovations ### Lead sponsors (1) - [Bavarian Nordic](https://trialight.com/data/company/bavarian-nordic-b9da5fa2-5358-470a-88a3-7c5c8c3c6a59.md) ### Conditions (1) - [Monkeypox](https://trialight.com/data/condition/monkeypox-060407a9-f18e-5843-a1cc-b66341f31496.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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