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About
This is a dose-escalation, Phase I/II trial evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox (mpox).
This trial will start with the two substudies, i.e., substudy A (SSA) and substudy B (SSB).
This trial will be initiated with the dose-escalation SSA. In substudy A and substudy B, dosing will start with an initial sentinel group, followed by the expansion cohort.
This study was initially planned to investigate two vaccine candidates (the quadrivalent BNT166a and the trivalent BNT166c). The sponsor decided to not activate the groups with BNT166c.
Full description
Substudy A is a dose-escalation, Phase I substudy to assess the reactogenicity, safety and immunogenicity of up to three dose levels of the multivalent vaccine candidate BNT166a in ~48 healthy participants with no prior history of known or suspected smallpox vaccination (vaccinia-naïve participants). Two doses will be given ~31 days apart.
Substudy B is a Phase I substudy to assess the reactogenicity, safety and immunogenicity of the multivalent vaccine candidate BNT166a in ~16 healthy participants with prior history of smallpox vaccination (vaccinia-experienced). Two doses will be given ~31 days apart.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
History of mpox, smallpox or vaccinia infection based on volunteer-reported medical history.
Pregnant, breastfeeding, planning pregnancy or planning to father children starting from Visit 0 and continuously until 90 days after receiving Dose 2.
History of known or suspected severe adverse reaction including allergic reaction (e.g., anaphylaxis) to vaccines or to vaccine components such as lipids.
Current or history of the following medical conditions at Visit 0 or Visit 1:
Schizophrenia, major depressive disorder, suicidal ideation. Such psychiatric illnesses, as bipolar disorder, autism and attention deficit-hyperactivity disorder that at the discretion of the investigator could interfere with participation and follow-up as outlined by the trial.
Current or history of the following diseases associated with immune dysregulation:
At Visit 0, any screening hematology and/or blood chemistry laboratory value that meets the definition of a Grade ≥1 abnormality (according to the toxicity grading scale; see separate criteria for indirect bilirubin and troponin I). Individuals with any stable Grade 1 abnormalities may be considered eligible at the discretion of the investigator. A stable Grade 1 laboratory abnormality is defined as the value which is ≤ Grade 1 upon repeated testing on a second sample from this individual during the screening period (prior to Visit 1). Individuals with abnormal but not clinically significant parameters not included in the toxicity guidance may be considered eligible at discretion of investigator.
Abnormal total bilirubin at Visit 0. Note: inclusion of volunteers with bilirubin ≤1.25 upper limit of normal (ULN) if due to Gilbert's syndrome is allowed.
Any abnormal troponin I value at Visit 0.
A 12-lead ECG at Visit 0 which is consistent with probable or possible myocarditis/pericarditis or which demonstrates clinically relevant abnormalities that may affect participant safety or are otherwise clinically significant findings (e.g., complete left bundle branch block, AV block, average corrected QT interval by Fridericia (QTcF interval) >450 msec, signs of myocardial infarction, ST elevation consistent with myocardial ischemia, or serious brady- or tachyarrhythmias).
Febrile illness (body temperature ≥38.0°C) or other acute illness within 48 hours prior to Dose 1 and/or current (if presented at Visit 1, temporary deferral is allowed).
Participation or planned participation in strenuous or endurance exercise within 7 days before or after each IMP administration.
SSA only: Vaccination with any Orthopoxvirus-based vaccine including vaccines for prevention of smallpox, disease caused by vaccinia virus or mpox, or vector Orthopoxvirus-based vaccines.
SSB only: Vaccination for prevention of mpox or disease caused by vaccinia virus, or with vector Orthopoxvirus-based vaccine. Vaccination for prevention of smallpox done in or after 1980.
Any vaccination within 28 days before Dose 1. Seasonal inactivated influenza vaccine is allowed, however, it should be administered at least 14 days before IMP administration.
Any non-trial IMP within 28 days or five half-lives (whichever is longer) before Dose 1.
Blood/plasma products and/or immunoglobulins within 120 days before Dose 1.
Allergy treatment with antigen injections within 14 days before Dose 1.
Immunosuppressive therapy, including corticosteroids, or radiotherapy within 6 months or five half-lives (whichever is longer) before Dose 1. If systemic corticosteroids have been administered short term (≤14 days, at a dose of ≤20 mg/day of prednisone or equivalent) for treatment of an acute illness, individuals should be enrolled in the trial only after corticosteroid therapy has been discontinued for at least 28 days before Dose 1. Intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Have a history of alcohol abuse within 1 year before Visit 0 or have a history of substance abuse within the past 5 years before Visit 0.
Are vulnerable individuals as per ICH E6 definition, i.e., are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
Primary purpose
Allocation
Interventional model
Masking
64 participants in 2 patient groups
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BioNTech clinical trials patient information
Data sourced from clinicaltrials.gov
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