| Eligibility |
Inclusion Criteria:
- Seronegative (Group 1): negative qualitative test for SARS-CoV-2 antibodies at SCR.
Seropositive (Group 2 and Group 3): Previous COVID-19 disease or previously completed
vaccination regimen with an authorized SARS-CoV-2 vaccine at least 90 days before planned
trial vaccination and a positive qualitative test for SARS-CoV-2 antibodies at SCR.
"Authorized" SARS-CoV-2 vaccine refers to authorization status at SCR, i.e., subjects can
be eligible if the subject previously received investigational vaccines that have since
been authorized for emergency use or granted full market licensure. Receipt of a single
dose of an authorized COVID-19 vaccine regimen in subjects with a previous diagnosis of
COVID-19 or a mix/match series of 2 doses of any authorized COVID-19 vaccine will be
considered as a completed vaccination.
- General good health, without acute medical illness, physical exam findings, or
laboratory abnormalities, as determined by the investigator.
- Body mass index (BMI) =18.5 and <40.
- Female subjects of childbearing potential (WOCBP) must agree to the use of an
effective method of birth control from at least 30 days prior to administration of the
vaccine until 30 days after the vaccination. Male subjects who are sexually active
with a WOCBP must agree to the use of an effective method of birth control from the
day of administration of the vaccine until 30 days after the vaccination.
- Negative human immunodeficiency virus antibody test (anti HIV), negative hepatitis B
surface antigen (HBsAG) and negative antibody to hepatitis C virus (HCV).
Exclusion Criteria:
• Group 1 only: History of COVID-19 infection or previous vaccination with a licensed or
candidate SARS-CoV-2 vaccine, or positive qualitative test for SARS-CoV-2 antibodies at
SCR.
Groups 2 and 3 only: History of COVID-19 infection and subsequent receipt of more than one
licensed or candidate SARS-CoV-2 vaccine.
- Positive test for SARS-CoV-2 infection at SCR.
- Pregnant or breastfeeding women.
- Subject has an acute or chronic medical condition that, in the opinion of the
investigator, would render the trial procedures unsafe or would interfere with the
evaluation of the responses.
- History of or active autoimmune disease. History of Guillain-Barré syndrome or Reye's
syndrome. Persons with vitiligo or thyroid disease taking thyroid replacement are not
excluded.
- Known or suspected impairment of immunologic functions including, but not limited to,
known immunodeficiency syndrome.
- History of malignancy other than squamous cell or basal cell skin cancer, unless there
has been surgical excision at least 6 months prior to SCR that is considered to have
achieved cure. Subjects with history of skin cancer must not be vaccinated at the
previous tumor site.
- Laboratory parameters (such as complete blood count, serum biochemistry including
aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline
phosphokinase [AP], bilirubin, or creatinine values), pulse rate, blood pressure, or
electrocardiogram (ECG) outside normal range at SCR and deemed clinically relevant by
the investigator.
- Clinically significant mental disorder not adequately controlled by medical treatment.
- Active or recent history (within 6 months before SCR) of chronic alcohol abuse,
intravenous drug abuse, or nasal drug abuse.
- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine.
- History of anaphylaxis or severe allergic reaction to any vaccine.
- Having received any vaccinations or planned vaccinations with a live vaccine within 30
days prior to or after trial vaccination.
- Having received any vaccinations or planned vaccinations with an inactivated vaccine
within 14 days prior to or after trial vaccination.
- Recent blood donation (including platelets, plasma and red blood cells) within 4 weeks
prior to SCR, or planned blood donations during the active trial phase.
- Chronic systemic administration (defined as more than 14 days of >5 mg prednisone [or
equivalent]/day), or any other immune-modifying drugs during a period starting 3
months prior to administration of the vaccine and ending 4 weeks after the last
vaccination. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is
allowed.
- Post organ transplant subjects, whether or not receiving chronic immunosuppressive
therapy.
- Administration or planned administration of immunoglobulins and/or any blood products
during a period starting 3 months prior to administration of the vaccine and ending 4
weeks after the last vaccination. Receipt of packed red blood cells given for an
emergency indication in an otherwise healthy person, and not required as ongoing
treatment is not exclusionary (for example packed red blood cells given in emergency
during an elective surgery).
- Use of any investigational or non-registered drug or vaccine other than the trial
vaccine within 30 days preceding the administration of trial vaccine, or planned
administration of such a drug or vaccine throughout the trial.
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