Monkey Pox
Conditions
Interventions
Sponsors
Bavarian Nordic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Paediatric Cohort 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 a. provide consent =8 years of age enrolled at sites in Uganda b. children deemed by the investigator and/or local regulations to be capable of assent in DRC 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 Adult Cohort Age 18 to 50 years at screening 2. Male or female sex 3. Informed consent form 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 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 a. 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 contr
Exclusion criteria
Exclusion criteria: 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 4. Known or reported previous smallpox vaccination or vaccination with any licensed or investigational poxvirus-based vaccine 5. History of monkeypox, cowpox, or vaccinia 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, for example leukaemia 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 10. Known allergy to aminoglycosides 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 imm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess immunogenicity of the MVA BN standard regimen in eliciting neutralizing antibodies against vaccinia virus in children compared to adults.Titer of serum neutralizing antibodies against vaccinia virus as measured by PRNTs 2 weeks after the second MVA BN vaccination.Ratio of the geometric mean titer (GMT) in children vs adults ;To assess the safety and reactogenicity of the MVA BN standard regimen in children and adults Occurrence of any: SAE at any time during the trial period AESI at any time during the trial period MAAE at any time during the trial period Grade 3 or higher related AE on the day of or within 28 days after either vaccination Solicited local AE on the day of or within 7 days after either vaccination Solicited systemic AE on the day of or within 7 days after either vaccination Unsolicited AE on the day of or within 28 days after either vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess neutralizing antibody response to the MVA BN standard regimen Seroconversion in neutralizing antibodies as determined by PRNT at all serum sampling time points after vaccination (ie, defined as either the appearance of antibody titer at or above the LLOQ for participants with baseline values below the LLOQ or doubling or more of the antibody titer compared to baseline for participants with a baseline antibody titer at or above the LLOQ) Seroconversion rate (by treatment group) | — |
Countries
Congo, Uganda
Contacts
Public ContactEvans Seko
Project Manager
Outcome results
None listed