None

None

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving the last dose of trial imp or intending to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national heart, lung, and blood institute asthma management guidelines. diabetes mellitus type 1 or type 2, or new onset of diabetes mellitus type 1 or 2 from the administration of dose 1, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. exclusion pertaining to dose 2: participants who have new onset of worsening hypertension since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in dose 2. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. exclusion pertaining to dose 2: participants who have new onset of cardiovascular disease since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in dose 2. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). exclusion pertaining to dose 2: participants who have new onset of a bleeding disorder since enrollment, that, in the opinion of the investigator, would constitute an increased risk to the individual's participation in dose 2. seizure disorders: history of seizure(s) within the past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. exclusion pertaining to dose 2: only symptomatic participants or whose clinical picture, in the opinion of the investigator, warrant ecg will have a repeat 12-lead ecg prior to dose 2. note: ecg changes including but not limited to: paroxysmal or sustained atrial or ventricular arrhythmias, atrioventricular (av) block (grade 2-3) or bundle branch block, diffuse st-segment elevation or pr-segment inversion, qtcf interval (qt interval corrected by the fridericia formula) >450 ms in men and >460 ms in women, changes supporting myocardial infarction and/or myocardial ischemia. exclusion pertaining to dose 2: subjects who have an ecg prior to dose 2 and have a change or new onset that, in the opinion of the investigator, should not receive dose 2. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. exclusion pertaining to dose 2: participants who have a change or new onset psychiatric illness. current or history of the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. exclusion pertaining to dose 2: participants who have a change or new onset immunodeficiency. received any non-trial imp within 28 days before visit 0 or visit 7. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized (except high doses as per exclusion criteria above), intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or visit 7 or administration is planned starting at visit 0 or prior to visit 7 until 120 days after the last imp administration in this trial. exclusion pertaining to dose 2: if 28 days after the participant's last imp dose had passed before they consent to continue dose 2, blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before dose 2 of imp (visit 7) continuously until 120 days after receiving dose 2 of imp. received allergy treatment with antigen injections within 28 days before visit 1 or visit 7 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine, aside from dose 1 of the current trial. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein (identified by any method) or troponin i value. note: participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. gilberts disease, in and of itself, is not considered exclusionary. exclusion pertaining to dose 2: only symptomatic participants or whose clinical picture, in the opinion of the investigator, warrant laboratory investigation, will have a repeat lab(s) prior to dose 2. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving the last dose of trial imp or intending to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national heart, lung, and blood institute asthma management guidelines. diabetes mellitus type 1 or type 2, or new onset of diabetes mellitus type 1 or 2 from the administration of dose 1, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. exclusion pertaining to dose 2: participants who have new onset of worsening hypertension since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in dose 2. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. exclusion pertaining to dose 2: participants who have new onset of cardiovascular disease since enrollment, that, in the opinion of the investigator would constitute an increased risk to the individual's participation in dose 2. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). exclusion pertaining to dose 2: participants who have new onset of a bleeding disorder since enrollment, that, in the opinion of the investigator, would constitute an increased risk to the individual's participation in dose 2. seizure disorders: history of seizure(s) within the past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. exclusion pertaining to dose 2: only symptomatic participants or whose clinical picture, in the opinion of the investigator, warrant ecg will have a repeat 12-lead ecg prior to dose 2. note: ecg changes including but not limited to: paroxysmal or sustained atrial or ventricular arrhythmias, atrioventricular (av) block (grade 2-3) or bundle branch block, diffuse st-segment elevation or pr-segment inversion, qtcf interval (qt interval corrected by the fridericia formula) >450 ms in men and >460 ms in women, changes supporting myocardial infarction and/or myocardial ischemia. exclusion pertaining to dose 2: subjects who have an ecg prior to dose 2 and have a change or new onset that, in the opinion of the investigator, should not receive dose 2. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. exclusion pertaining to dose 2: participants who have a change or new onset psychiatric illness. current or history of the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. exclusion pertaining to dose 2: participants who have a change or new onset immunodeficiency. received any non-trial imp within 28 days before visit 0 or visit 7. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized (except high doses as per exclusion criteria above), intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or visit 7 or administration is planned starting at visit 0 or prior to visit 7 until 120 days after the last imp administration in this trial. exclusion pertaining to dose 2: if 28 days after the participant's last imp dose had passed before they consent to continue dose 2, blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before dose 2 of imp (visit 7) continuously until 120 days after receiving dose 2 of imp. received allergy treatment with antigen injections within 28 days before visit 1 or visit 7 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine, aside from dose 1 of the current trial. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein (identified by any method) or troponin i value. note: participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. gilberts disease, in and of itself, is not considered exclusionary. exclusion pertaining to dose 2: only symptomatic participants or whose clinical picture, in the opinion of the investigator, warrant laboratory investigation, will have a repeat lab(s) prior to dose 2. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving the last dose of trial imp or intending to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national heart, lung, and blood institute asthma management guidelines. diabetes mellitus type 1 or type 2, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). seizure disorders: history of seizure(s) within past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. note: ecg changes including but not limited to: paroxysmal or sustained atrial or ventricular arrhythmias, atrioventricular (av) block (grade 2-3) or bundle branch block, diffuse st-segment elevation or pr-segment inversion, qtcf interval (qt interval corrected by the fridericia formula) >450 ms in men and >460 ms in women, changes supporting myocardial infarction and/or myocardial ischemia. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. current or history of the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. received any non-trial imp within 28 days before visit 0. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized (except high doses as per exclusion criteria above), intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or administration is planned starting at visit 0 until 120 days after the last imp administration in this trial. received allergy treatment with antigen injections within 28 days before visit 1 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein or troponin i value. note: with the exception of bilirubin, participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving the last dose of trial imp or intending to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national heart, lung, and blood institute asthma management guidelines. diabetes mellitus type 1 or type 2, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, symptomatic congestive heart failure, cardiomyopathy or clinically significant arrhythmias. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). seizure disorders: history of seizure(s) within past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. note: ecg changes including but not limited to: paroxysmal or sustained atrial or ventricular arrhythmias, atrioventricular (av) block (grade 2-3) or bundle branch block, diffuse st-segment elevation or pr-segment inversion, qtcf interval (qt interval corrected by the fridericia formula) >450 ms in men and >460 ms in women, changes supporting myocardial infarction and/or myocardial ischemia. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. current or history of the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. received any non-trial imp within 28 days before visit 0. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized (except high doses as per exclusion criteria above), intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or administration is planned starting at visit 0 until 120 days after the last imp administration in this trial. received allergy treatment with antigen injections within 28 days before visit 1 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein or troponin i value. note: with the exception of bilirubin, participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving the last dose of trial imp or intending to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components such as antibiotics or lipids, etc., and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national asthma education and prevention program expert panel report. diabetes mellitus type 1 or type 2, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). seizure disorders: history of seizure(s) within past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. current or history of the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. received any non-trial imp within 28 days before visit 0. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or administration is planned starting at visit 0 until 120 days after the last imp administration in this trial. received allergy treatment with antigen injections within 28 days before visit 1 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein or troponin i value. note: with the exception of bilirubin, participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving the last dose of trial imp or intending to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components such as antibiotics or lipids, etc., and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national asthma education and prevention program expert panel report. diabetes mellitus type 1 or type 2, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). seizure disorders: history of seizure(s) within past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. current or history of the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. received any non-trial imp within 28 days before visit 0. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or administration is planned starting at visit 0 until 120 days after the last imp administration in this trial. received allergy treatment with antigen injections within 28 days before visit 1 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein or troponin i value. note: with the exception of bilirubin, participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving last dose or to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components such as antibiotics or lipids, etc., and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national asthma education and prevention program expert panel report. diabetes mellitus type 1 or type 2, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). seizure disorder: history of seizure(s) within past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. received any non-trial imp within 28 days before visit 0. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or administration is planned starting at visit 0 until 120 days after the last imp administration in this trial. received allergy treatment with antigen injections within 28 days before visit 1 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein or troponin i value. note: with the exception of bilirubin, participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.

breastfeeding or intending to become pregnant starting with visit 0 until 28 days after receiving last dose or to father children starting with visit 0 until 28 days after receiving the last trial imp dose. history of any severe adverse reactions to vaccines or to vaccine components such as antibiotics or lipids, etc., and including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (not excluded from participation: a volunteer who had an anaphylactic adverse reaction to pertussis vaccine as a child). current or history of the following medical conditions: uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease); symptoms of asthma severity as defined in the most recent us national asthma education and prevention program expert panel report. diabetes mellitus type 1 or type 2, including cases controlled with diet alone (not excluded: history of isolated gestational diabetes). hypertension: if a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. well controlled blood pressure is defined as consistently ≤140 mm hg systolic and ≤90 mm hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤150 mm hg systolic and ≤90 mm hg diastolic at visit 0. if a person does not have a history of elevated blood pressure or hypertension previously or during screening, also exclude for systolic blood pressure ≥150 mm hg at visit 0 or diastolic blood pressure ≥100 mm hg at visit 0. any current or history of cardiovascular diseases such as myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias. a diagnosed bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions). seizure disorder: history of seizure(s) within past 3 years. also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years. screening 12-lead ecg that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of the trial results. current or history of major psychiatric illness, including but not limited to bipolar disorder, major depressive disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that could interfere with participation and follow-up as required by the trial protocol. the following diseases associated with immune dysregulation: primary immunodeficiencies. history of solid organ or bone marrow transplantation. asplenia: any condition resulting in the absence of a functional spleen. currently existing or history of autoimmune disease including and not limited to thyroid autoimmune disease, multiple sclerosis, or psoriasis. received any non-trial imp within 28 days before visit 0. received or planned treatment throughout the entire trial with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial. inhaled/nebulized, intraarticular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. blood/plasma products and/or immunoglobulin containing therapy (including monoclonal antibodies) received within 120 days before visit 1 or administration is planned starting at visit 0 until 120 days after the last imp administration in this trial. received allergy treatment with antigen injections within 28 days before visit 1 or where allergy treatment with antigen injections are scheduled within 14 days after any visit with imp administration in this trial. participants with a history of sars-cov-2 infection (symptomatic or asymptomatic) <60 days prior to randomization. have received any non-rna or unauthorized covid-19 vaccine. any existing condition which may affect imp administration and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. are vulnerable individuals as per international council for harmonisation (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. any screening hematology and/or blood chemistry laboratory value that meets the definition of a grade ≥1 abnormality at visit 0, or an abnormal c-reactive protein or troponin i value. note: with the exception of bilirubin, participants with any stable grade 1 abnormalities (according to the toxicity grading scale) may be considered eligible at the discretion of the investigator. history of alcohol abuse or drug addiction within 1 year before visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments.