KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers

Inclusion Criteria

• Subject read, understood, and signed the informed consent form (ICF).
• Healthy adult males and females 18-49 years of age (Part A) or 50-85 years of age (Part B), inclusive, at screening.
• RT-PCR negative at time of screening.
• Body mass index (BMI) of ≥ 18 and ≤ 30 kg/m2 at screening. BMI = weight (kg)/(height [m])2.
• Must be in general good health before study participation with no clinically relevant abnormalities that could interfere with study assessments.
• Women of childbearing potential (WOCBP) and men whose sexual partners are WOCBP must be able and willing to use at least 1 highly effective method of contraception (ie, include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, hormonal oral [in combination with male condoms with spermicide], transdermal, implant, or injection, barrier [ie, condom, diaphragm with spermicide]; intrauterine device; vasectomized partner [6 months minimum], clinically sterile partner; or abstinence) during the study. A female subject is considered to be a WOCBP after menarche and until she is in a postmenopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile. Note: Subjects not of childbearing potential are not required to use any other forms of contraception during the study. Non-childbearing potential is defined as subject confirmed:
• Surgical sterilization (eg, bilateral oophorectomy, bilateral salpingectomy, bilateral occlusion by cautery [Essure System is not acceptable], hysterectomy, or tubal ligation).
• Postmenopausal (defined as permanent cessation of menstruation for at least 12 consecutive months prior to screening) with FSH ≥ 30 mIU/mL at screening.
• WOCBP must have a negative urine pregnancy test before each vaccination.
• Must be able to attend all visits, including unscheduled visits if respiratory symptoms develop during the study, for the duration of the study and comply with all study procedures, including daily completion of the Diary Card for 7 days after each injection.

Exclusion Criteria

• History of an acute or chronic medical condition including dementia that, in the opinion of the Investigator, would render vaccination unsafe or would interfere with the evaluation of responses. Chronic conditions that are NOT included on the Center for Disease Control's list of subjects at higher risk for severe illness from SARS-CoV-2 are acceptable if the condition has been stable for the 3 months prior to vaccine administration (Day 1), with no medication changes, and no hospitalization in the past 6 months.
• History of any medical conditions that place subjects at higher risk for severe illness due to SARS-CoV-2 including but not limited to cancer, chronic kidney disease at any stage, chronic lung disease, dementia or other neurological conditions, diabetes (Type 1 or Type 2), Down syndrome, heart conditions, human immunodeficiency virus (HIV) infection, immunocompromised state (weakened immune system), liver disease, overweight/obesity, pregnancy, sickle cell disease or thalassemia, smoker (current or former), transplants (solid organ or blood stem cell), stroke or cerebrovascular disease, and substance use disorders.
• History of ongoing clinical condition or medication or treatments that may adversely affect the immune system.
• Individuals who are PCR positive for SARS-CoV-2 at screening or prior to second dose of TAP-COVID-19 vaccine.
• Individuals who are at increased risk of exposure to SARS-CoV-2 (eg, healthcare workers, emergency responders).
• Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration.
• Living in a group care facility (eg, assisted living or nursing home).
• Individuals with any elevated (Grade 1 or higher) laboratory test assessed as clinically significant for age by the Investigator at screening.
• Individuals with any elevated (Grade 1 or higher) liver function enzyme at screeni