Created at Source Raw Value Validated value
Jan. 13, 2022, 11 p.m. oms

Receipt of medications or vaccines intended to prevent or treat COVID-19 infection in the past. Fever (non-axillary temperature > 37.5 ºC) or any other symptoms of infection that have not completely resolved including respiratory symptoms/illnesses within the past 3 days from randomization (Day 0) Participants with a BMI > 35 kg/m2. A major or clinically significant medical condition. Individuals currently working in occupations with high risk of exposure to SARS-CoV Pregnant or lactating women or willingness/intention to become pregnant during the study. History of allergy to any component of the RBD SARS-CoV-2 HBsAg VLP Vaccine, or serious adverse reactions to the vaccine A history of anaphylaxis to a vaccine, food, drug, toxin or other exposure Known hypersensitivity reactions to yeast. Positive test result at screening for HIV ½ antibody, HBsAg or HCV Ab Clinical laboratory tests of blood and urine not within the normal range and show clinically relevant deviations as judged by the Investigator. History of demyelinating disease or Guillain Barre syndrome Eczema or other significant skin lesion or infection at the site/s of vaccination Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination Positive screen for drugs of abuse or alcohol (breath test) at screening and randomization (Day 0). (Drugs of abuse include amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, and tetrahydrocannabinol). Participants who currently smoke at least 10 cigarettes or equivalent per day Receipt of blood/blood products/immunoglobulins or donation of blood/blood products 8 weeks prior to vaccination or planned receipt or donation during the study period Any other medical condition which in the opinion of the Investigator may affect the subject’s safety or study participation and conduct.

Receipt of medications or vaccines intended to prevent or treat COVID-19 infection in the past. Fever (non-axillary temperature > 37.5 ºC) or any other symptoms of infection that have not completely resolved including respiratory symptoms/illnesses within the past 3 days from randomization (Day 0) Participants with a BMI > 35 kg/m2. A major or clinically significant medical condition. Individuals currently working in occupations with high risk of exposure to SARS-CoV Pregnant or lactating women or willingness/intention to become pregnant during the study. History of allergy to any component of the RBD SARS-CoV-2 HBsAg VLP Vaccine, or serious adverse reactions to the vaccine A history of anaphylaxis to a vaccine, food, drug, toxin or other exposure Known hypersensitivity reactions to yeast. Positive test result at screening for HIV ½ antibody, HBsAg or HCV Ab Clinical laboratory tests of blood and urine not within the normal range and show clinically relevant deviations as judged by the Investigator. History of demyelinating disease or Guillain Barre syndrome Eczema or other significant skin lesion or infection at the site/s of vaccination Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination Positive screen for drugs of abuse or alcohol (breath test) at screening and randomization (Day 0). (Drugs of abuse include amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, and tetrahydrocannabinol). Participants who currently smoke at least 10 cigarettes or equivalent per day Receipt of blood/blood products/immunoglobulins or donation of blood/blood products 8 weeks prior to vaccination or planned receipt or donation during the study period Any other medical condition which in the opinion of the Investigator may affect the subject’s safety or study participation and conduct.