A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001)

Exclusion Criteria

• •Is currently actively infected with SARS-CoV-2 (confirmed by polymerase chain reaction;\[PCR\]).
• •Has prior medical history of confirmed SARS-CoV-2 infection or known exposure to an individual with confirmed coronavirus disease 2019 (COVID-19) disease or SARS CoV-2 infection within the past 2 weeks. With the exception of the sentinel participants (Panel A, Panel B, and the first 5 participants of Panel E), study participants will not be screened for enrollment by SARS-CoV-2 serology, allowing those who may have had a prior asymptomatic SARS-CoV-2 infection to be enrolled.
• •Has a history of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of known or suspected allergic reaction likely to be exacerbated by any component of the COVID-19 vaccine.
• •Is currently (or highly suspected to be) immunocompromised, including anticipating the need for systemic immunosuppressive treatment within the next 6 months or 12 months for 2-dose Day 1, Day 169 panels or has been diagnosed or highly suspected as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition that could impact the immune response or the safety of the study vaccine.
• •Has clinically significant thrombocytopenia or other coagulation disorder contraindicating intramuscular vaccination or repeated venipuncture.
• •Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study or interfere with the participant's participation for the full duration of the study.
• •Has a history or presence of clinically significant pulmonary disorders (e.g. chronic obstructive pulmonary disease \[COPD\], etc.), or asthma.
• •Has a history of confirmed SARS-CoV-1 or Middle Eastern respiratory syndrome (MERS)
• •Has a history of or current clinically significant medical condition that puts or may put a participant at increased risk for severe SARS-CoV-2 disease, such as conditions associated with increased risk of severe illness from COVID-19, cancer, chronic kidney disease, COPD, immunocompromised state (weakened immune system) from solid organ transplant, obesity (BMI of 30 or higher), serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies, sickle cell disease, Type 2 diabetes mellitus, asthma, cerebrovascular disease, cystic fibrosis, hypertension or high blood pressure, an immunocompromised state (weakened immune system), neurologic conditions, such as dementia, liver disease, pregnancy, pulmonary fibrosis (having damaged or scarred lung tissues), smoking, thalassemia (a type of blood disorder), or Type 1 diabetes mellitus.
• •Part 2B ONLY: Older adult participants having mild, well controlled hypertension as is widely characteristic of aging are allowed if their medication regimens have not substantively changed for the past 6 months, hypertension has not led to hospitalization or currently increased rate of clinic visits over the past year, and hypertension has not been confirmed as putting subjects at increased risk of severe illness from COVID-19 by the CDC (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html).
• •Is mentally or legally incapacitated, has significant emotional problems at the time of pre-study (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years.
• •Has a history of any clinically significant major neurological disorders or seizures (including Guillain-Barré syndrome), with the exception of febrile seizures during childhood.
• •Has a history of cancer (malignancy)
• •Has a known or suspected history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., systemic allergic reaction) to prescription or non-prescription drugs or food.
• •Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)-1 or 2 antibodies. Individuals with antibodies to hepatitis C may be enrolled if hepatitis C viral load is undetectable and there is no evidence of or history of liver disease.
• •Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pre-study (screening) visit.
• •Has received immunosuppressive drugs (like e.g. systemic corticosteroids, excluding topical preparations and inhalers) within 3 months prior to the first vaccination or 6 months for chemotherapies.
• •\*Has received vaccination within 4 weeks prior to first vaccination or is planning to receive a licensed vaccine 4 weeks before or after each study vaccination (e.g.
• •Inactivated influenza vaccine).
• •\*Has received measles-containing vaccine within 3 months prior to the first vaccination.
• •Has received a blood transfusion or blood products, including immunoglobulin, starting from 3 months before the first study vaccination or is scheduled to receive a blood transfusion or blood product through study completion. Autologous blood transfusions are not considered an exclusion criterion.
• •Is unable to meet the concomitant medication restrictions
• •Is using antiviral medications or any investigational agents for prophylaxis of SARSCoV-2 within 4 weeks prior to the first vaccination.
• •Has ever participated in an investigational study of a SARS-CoV-2 vaccine, or an antiviral or other biologic product intended for the treatment of COVID-19.
• •Is currently participating in any study of a vaccine or investigational medicinal product (IMP) or has recently completed participation in another study of a vaccine or IMP and received a vaccine within 3 months prior to screening or an IMP within 4 weeks (or 5 half-lives of the IMP, whichever is longer) prior to the pre-study (screening) visit. The window will be derived from the date of the last study intervention (e.g., receiving a vaccine or IMP) in the previous study to the date of the pre-study (screening) visit for this study. In addition, a participant cannot participate in another investigational trial up to the post-trial visit of this study (approximately 12 months after the last study vaccination).
• •Has glycated hemoglobin (A1C) ≥ 6.5% at screening.
• •Has a history of alcohol, cocaine, or opioid abuse during the previous 3 years.
• •Participants who currently smoke or used nicotine or nicotine-containing products (e.g. nicotine patch) within last 3 months. Former smokers that have less than a 10 pack-year history of smoking and have not smoked in the last 12 months are eligible to be enrolled.
• •Has a tattoo, scar or other physical finding at the area of the vaccination site that would interfere with intramuscular injection or a local tolerability assessment.
• •Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study.
• •Lives in a nursing home or long-term care facility.
• •Is currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g., health care worker with direct patient contact, emergency response personnel), or, at the investigator's discretion to be at increased risk to acquire SARS-CoV-2 for any other reason.
• •Individuals who are living and/or working with severely immunocompromised people, pregnant women, lactating women, children under 12 months old, or any other individual that, in the judgment of the investigator, might be at increased risk.
• •Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigatively involved with this study.