Inclusion/Exclusion Criterion
Had acute illness, with or without fever, within 72h prior to 1st immunization. Acute illness resolved with minor symptoms, in opinion of the invest., symptoms will not compromise their well-being.
Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.
Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
Had any major surgery within past 5 years, in opinion of the invest., could compromise their well-being if they participate in trial, or that prevent, limit, or confound prot. specified assessments.
Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.
Chronic use (>14 days) of systemic meds., including immunosuppressant, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety.
Chronic use (>14 days) of systemic meds., including immunosuppressants, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety.
Chronic use (>21 days) of systemic meds., including immunosuppressants, 6mo prior to Visit 0, unless med. would not prevent, limit, confound the prot. specified assessments or compromise safety.
Chronic use (>21 days) of systemic meds., including immunosuppressants (except for Cohort 13), 6mo prior to Visit 0, unless med. would not prevent, limit, confound assessments or compromise safety.
Received any vaccination within the 28 d prior to Visit 0.
Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0.
Had administration of another investigational product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0.
Had administration of another investigational medicinal product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0.
Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C, within the 30 d prior to Visit 0.
Have a known history or a positive test of any of the following: HIV 1 or 2, Hepatitis B, Hepatitis C.
Have a known history or a positive test of any of HIV 1 or 2, Hepatitis B, or Hepatitis C (except for Cohort 13), within the 30 d prior to Visit 0.
Have a positive PCR-based test for anti-SARS-CoV-2 within the 30 d prior to Visit 0.
Have a positive PCR-based test for anti-SARS-CoV-2 within the 30 d prior to Visit 1.
Positive drugs of abuse (amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or 1.
Have a positive breath alcohol test at Visit 0 or Visit 1.
Previously participated in an investigational trial involving lipid nanoparticles.
Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial.
Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. Allowed participation in non-COVID-19 trials after entering follow-up phase.
Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site).
History (past 5 years) of substance abuse or known medical, psycho., or social conditions which compromise well-being as trial subjects, or prevent, limit, or confound the prot. specified assessments.
Have a history of hypersensitivity or serious reactions to previous vaccinations.
Have a history of Guillain-Barre Syndrome within 6 wks following a previous vaccination.
Have history of alcohol abuse or drug addiction within 1 year before Visit 0.
Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0.
(Except for Cohort 13) Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0.
Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site.
Had any blood loss >450 mL, within the 7d prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 d after receiving the last immunization.
They were in any country with a high SARS-CoV-2 infection risk (as defined by the RKI at the time Visit 0) within the 14 d prior to Visit 0.
They plan to visit any country with a high SARS-CoV-2 infection risk (as defined by the RKI at the time Visit 0), from Visit 0 until 14 d after receiving the last immunization.
Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties.
(Once commercially available in Germany) Have a positive test for anti-SARS-CoV-2 antibodies.
Have had contact with persons tested positive for SARS-CoV-2 antibodies within the 30 d prior to Visit 0.
Are soldiers, subjects in detention, CRO or sponsor staff or their family members.
Are vulnerable persons, i.e., soldiers, subjects in detention, CRO or sponsor staff or their family members.
Regular receipt of inhaled/nebulized corticosteroids.
For older adults only: Have a condition known to put them at high risk for severe COVID-19.
For older adults only: Have a condition known to put them at high risk for severe COVID-19. (BMI removed as risk factor.)
For older adults and Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19.
Have given informed consent by signing the ICF before initiation of any trial-specific procedures.
Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to reduce COVID-19 exposure), and other requirements of the trial.
They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the trial.
They must be able to understand and follow trial-related instructions.
They must be aged from 18 to 55 years, have a body mass index of over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
They must be aged 18 <= 55 years and weigh at least 50 kg at Visit 0.
They must be aged from 18 to 55 years (Cohorts 1 to 8) or 65 to 85 years (elderly subject cohorts), have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
For younger cohorts, must be aged from 18-55 years. For older cohorts, must be aged 56-85 years. Must have a body mass index over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
Must be healthy based on MH, PE, 12-lead ECG, VS (systolic/diastolic BP, pulse rate, temp., respiratory rate), and clinical lab tests (blood chemistry, hematology, and urine chemistry) at Visit 0.
Must be healthy based on MH, PE, ECG, VS (BP, pulse rate, temp., respiratory rate), and clinical lab tests at Visit 0. Healthy volunteers with pre-existing stable disease can be included.
Must be healthy in clinical judgment of investigator at Visit 0. For cohort 13, volunteers must be immunocompromised but otherwise healthy.
WOCBP have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized be considered as not having reproductive potential.
WOCBP must agree to practice one highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
WOCBP must agree to practice two highly effective forms of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
WOCBP must practice a highly effective form of contraception, starting after Visit 0 and continuously until 60 d after receiving the last immunization, and must require male partners to use condoms.
WOCBP must confirm that they practiced one highly effective form of contraception for the 14 d prior to Visit 0.
WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0.
WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
Men sexually active with WOCBP and not had a vasectomy must agree to practice a contraception with female of childbearing potential, after Visit 0 and until 60d after receiving the last immunization.
Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
They must have confirmation of their health insurance coverage prior to Visit 0.
They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 d after receiving the last immunization.