Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells
Trial Parameters
Brief Summary
andomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in adults
Eligibility Criteria
Inclusion Criteria: 1. 18 to 49 years of age 2. 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 3. General good health, without clinically relevant medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator that would interfere with the trial 4. Body mass index (BMI) ≥18.5 and ≤35 (calculated as \[body weight in kg\]/\[body height in m\]2 ) 5. 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 inclu