any current acute illness requiring medical or surgical care, or chronic illness (excluding hiv in hiv-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable. chronic disease, including: hypertension (elevated blood pressure [bp]) ≥ grade 2 (systolic bp ≥ 160 mmhg; and/or diastolic bp ≥ 100 mmhg) according to the south african hypertension society's practice guidelines. note: hypertension [elevated bp] ≤ grade 1 (systolic bp ≤ 159 mmhg; diastolic bp ≤ 99 mmhg) according to the south african hypertension society's practice guidelines is not exclusionary; congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years; chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the past 2 years; evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator; note: stable coronary heart disease is not exclusionary. asthma requiring regular/chronic control medication (eg, short-acting beta2-agonist [saba] > 2 days per week; or any chronic use of inhaled corticosteroids [ics], long-acting beta2-agonist [laba], leukotriene receptor antagonist [ltra], or oral corticosteroids), and/or worsening of asthma symptoms in the past 3 months; note: asthma not requiring regular/chronic control medication, and not requiring saba > 2 days per week, and not demonstrating worsening of symptoms in the past 3 months, will not be excluded. type 1 or 2 diabetes (adult onset) requiring treatment with insulin; note: non-insulin dependent type 2 diabetes is not exclusionary. chronic kidney disease/renal insufficiency; chronic gastrointestinal and hepatic diseases; chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), or a history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms; note: history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary. participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. prior receipt of investigational or approved covid-19 vaccine at any time. history of a diagnosis of suspected or confirmed covid-19. received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first study vaccination. any autoimmune or immunodeficiency disease/condition (excluding hiv in hiv-positive patients). chronic (more than 14 days continuous) administration of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). acute respiratory and/or non-respiratory illness consistent with potential covid-19, concurrent with or within 14 days prior to first study vaccination, or documented temperature of > 38°c during this period. known blood clotting disorder. active cancer (malignancy) within 3 years prior to first study vaccination (with the exception of adequately treated non-melanoma skin cancers, as assessed by the investigator). any known allergies to products contained in the investigational product, or latex allergy, or any history of anaphylaxis in relation to any previous vaccination. women who are breastfeeding or who are pregnant at the time of screening, or plan to become pregnant within the first 6 months of the study. history of alcohol abuse or drug addiction within 2 years prior to the first study vaccination. any condition (other than hiv in hiv-positive subjects) that, in the opinion of the investigator, would pose a health risk to the subject if they participate in the study, or could interfere with evaluation of the study vaccine or interpretation of study results. study team member or first-degree relative of any study member. other protocol-defined inclusion/exclusion criteria may apply

any current acute illness requiring medical or surgical care, or chronic illness (excluding hiv in hiv-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable. chronic disease, including: hypertension (elevated blood pressure [bp]) ≥ grade 2 (systolic bp ≥ 160 mmhg; and/or diastolic bp ≥ 100 mmhg) according to the south african hypertension society's practice guidelines. note: hypertension [elevated bp] ≤ grade 1 (systolic bp ≤ 159 mmhg; diastolic bp ≤ 99 mmhg) according to the south african hypertension society's practice guidelines is not exclusionary; congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years; chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the past 2 years; evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator; note: stable coronary heart disease is not exclusionary. asthma requiring regular/chronic control medication (eg, short-acting beta2-agonist [saba] > 2 days per week; or any chronic use of inhaled corticosteroids [ics], long-acting beta2-agonist [laba], leukotriene receptor antagonist [ltra], or oral corticosteroids), and/or worsening of asthma symptoms in the past 3 months; note: asthma not requiring regular/chronic control medication, and not requiring saba > 2 days per week, and not demonstrating worsening of symptoms in the past 3 months, will not be excluded. type 1 or 2 diabetes (adult onset) requiring treatment with insulin; note: non-insulin dependent type 2 diabetes is not exclusionary. chronic kidney disease/renal insufficiency; chronic gastrointestinal and hepatic diseases; chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), or a history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms; note: history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary. participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. prior receipt of investigational or approved covid-19 vaccine at any time. history of a diagnosis of suspected or confirmed covid-19. received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first study vaccination. any autoimmune or immunodeficiency disease/condition (excluding hiv in hiv-positive patients). chronic (more than 14 days continuous) administration of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). acute respiratory and/or non-respiratory illness consistent with potential covid-19, concurrent with or within 14 days prior to first study vaccination, or documented temperature of > 38°c during this period. known blood clotting disorder. active cancer (malignancy) within 3 years prior to first study vaccination (with the exception of adequately treated non-melanoma skin cancers, as assessed by the investigator). any known allergies to products contained in the investigational product, or latex allergy, or any history of anaphylaxis in relation to any previous vaccination. women who are breastfeeding or who are pregnant at the time of screening, or plan to become pregnant within the first 6 months of the study. history of alcohol abuse or drug addiction within 2 years prior to the first study vaccination. any condition (other than hiv in hiv-positive subjects) that, in the opinion of the investigator, would pose a health risk to the subject if they participate in the study, or could interfere with evaluation of the study vaccine or interpretation of study results. study team member or first-degree relative of any study member. other protocol-defined inclusion/exclusion criteria may apply

- any current acute illness requiring medical or surgical care, or chronic illness (excluding hiv in hiv-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable. - chronic disease, including: 1. hypertension (elevated blood pressure [bp]) ≥ grade 2 (systolic bp ≥ 160 mmhg; and/or diastolic bp ≥ 100 mmhg) according to the south african hypertension society's practice guidelines. note: hypertension [elevated bp] ≤ grade 1 (systolic bp ≤ 159 mmhg; diastolic bp ≤ 99 mmhg) according to the south african hypertension society's practice guidelines is not exclusionary; 2. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years; 3. chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the past 2 years; 4. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator; note: stable coronary heart disease is not exclusionary. 5. asthma requiring regular/chronic control medication (eg, short-acting beta2-agonist [saba] > 2 days per week; or any chronic use of inhaled corticosteroids [ics], long-acting beta2-agonist [laba], leukotriene receptor antagonist [ltra], or oral corticosteroids), and/or worsening of asthma symptoms in the past 3 months; note: asthma not requiring regular/chronic control medication, and not requiring saba > 2 days per week, and not demonstrating worsening of symptoms in the past 3 months, will not be excluded. 6. type 1 or 2 diabetes (adult onset) requiring treatment with insulin; note: non-insulin dependent type 2 diabetes is not exclusionary. 7. chronic kidney disease/renal insufficiency; 8. chronic gastrointestinal and hepatic diseases; 9. chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), or a history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms; note: history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary. - participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. - prior receipt of investigational or approved covid-19 vaccine at any time. - history of a diagnosis of suspected or confirmed covid-19. - received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first study vaccination. - any autoimmune or immunodeficiency disease/condition (excluding hiv in hiv-positive patients). - chronic (more than 14 days continuous) administration of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. - received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). - acute respiratory and/or non-respiratory illness consistent with potential covid-19, concurrent with or within 14 days prior to first study vaccination, or documented temperature of > 38°c during this period. - known blood clotting disorder. - active cancer (malignancy) within 3 years prior to first study vaccination (with the exception of adequately treated non-melanoma skin cancers, as assessed by the investigator). - any known allergies to products contained in the investigational product, or latex allergy, or any history of anaphylaxis in relation to any previous vaccination. - women who are breastfeeding or who are pregnant at the time of screening, or plan to become pregnant within the first 6 months of the study. - history of alcohol abuse or drug addiction within 2 years prior to the first study vaccination. - any condition (other than hiv in hiv-positive subjects) that, in the opinion of the investigator, would pose a health risk to the subject if they participate in the study, or could interfere with evaluation of the study vaccine or interpretation of study results. - study team member or first-degree relative of any study member. other protocol-defined inclusion/exclusion criteria may apply

- any current acute illness requiring medical or surgical care, or chronic illness (excluding hiv in hiv-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable. - chronic disease, including: 1. hypertension (elevated blood pressure [bp]) ≥ grade 2 (systolic bp ≥ 160 mmhg; and/or diastolic bp ≥ 100 mmhg) according to the south african hypertension society's practice guidelines. note: hypertension [elevated bp] ≤ grade 1 (systolic bp ≤ 159 mmhg; diastolic bp ≤ 99 mmhg) according to the south african hypertension society's practice guidelines is not exclusionary; 2. congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years; 3. chronic obstructive pulmonary disease (copd) with a history of an acute exacerbation of any severity in the past 2 years; 4. evidence of unstable coronary artery disease in the past 3 months, as determined by the investigator; note: stable coronary heart disease is not exclusionary. 5. asthma requiring regular/chronic control medication (eg, short-acting beta2-agonist [saba] > 2 days per week; or any chronic use of inhaled corticosteroids [ics], long-acting beta2-agonist [laba], leukotriene receptor antagonist [ltra], or oral corticosteroids), and/or worsening of asthma symptoms in the past 3 months; note: asthma not requiring regular/chronic control medication, and not requiring saba > 2 days per week, and not demonstrating worsening of symptoms in the past 3 months, will not be excluded. 6. type 1 or 2 diabetes (adult onset) requiring treatment with insulin; note: non-insulin dependent type 2 diabetes is not exclusionary. 7. chronic kidney disease/renal insufficiency; 8. chronic gastrointestinal and hepatic diseases; 9. chronic neurological diseases (such as multiple sclerosis, dementia, transient ischemic attacks, parkinson's disease, degenerative neurological conditions, neuropathy, or epilepsy), or a history of stroke within 12 months with residual symptoms, or previous neurological disorder within 12 months with residual symptoms; note: history of migraine or chronic headaches, or nerve root compression that have been stable on treatment for the last 4 weeks are not exclusionary. - participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination. - prior receipt of investigational or approved covid-19 vaccine at any time. - history of a diagnosis of suspected or confirmed covid-19. - received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first study vaccination. - any autoimmune or immunodeficiency disease/condition (excluding hiv in hiv-positive patients). - chronic (more than 14 days continuous) administration of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). note: an immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. the use of topical, inhaled, and nasal glucocorticoids will be permitted. - received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination (excluding haart in hiv-positive subjects). - acute respiratory and/or non-respiratory illness consistent with potential covid-19, concurrent with or within 14 days prior to first study vaccination, or documented temperature of > 38°c during this period. - known blood clotting disorder. - active cancer (malignancy) within 3 years prior to first study vaccination (with the exception of adequately treated non-melanoma skin cancers, as assessed by the investigator). - any known allergies to products contained in the investigational product, or latex allergy, or any history of anaphylaxis in relation to any previous vaccination. - women who are breastfeeding or who are pregnant at the time of screening, or plan to become pregnant within the first 6 months of the study. - history of alcohol abuse or drug addiction within 2 years prior to the first study vaccination. - any condition (other than hiv in hiv-positive subjects) that, in the opinion of the investigator, would pose a health risk to the subject if they participate in the study, or could interfere with evaluation of the study vaccine or interpretation of study results. - study team member or first-degree relative of any study member. other protocol-defined inclusion/exclusion criteria may apply