A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19

Inclusion Criteria:

1. Male or females ≥12 years of age, inclusive*.

2. Participants who are willing and able to comply with study requirements, including all
scheduled visits, vaccinations, laboratory tests, the electronic completion of the
COVID-19 ePRO and other study procedures.

3. Healthy adult or adolescent subjects or adult or adolescent subjects with pre-existing
medical conditions who are in stable condition. A stable medical condition is defined
as disease not requiring significant change in therapy or hospitalization for
worsening disease during the 3 months before enrollment.

*Note: The first 200 individuals enrolled in the Phase 2 part of the study should be
healthy subjects 18 to 64 years or age without comorbidities associated with a high
risk of severe COVID-19

4. Female subjects who are WOCBP are eligible to participate in the study if not
pregnant, not breastfeeding, and at least 1 of the following criteria apply:

- WOCBP must have a negative urine pregnancy test prior to each vaccination. A
confirmatory serum pregnancy test may be conducted at the investigator's
discretion.

- They must be using a highly effective licensed method of birth control for 30
days prior to the first vaccination and must agree to continue such precautions
during the study until 90 days after the second vaccination.

5. Male subjects must agree to employ acceptable contraception from the day of first dose
of the study vaccine/placebo until 6 months after the last dose of the study
vaccine/placebo and also refrain from donating sperm during this period.

6. Individuals (or their legally acceptable representative based on local regulations)
willing and able to give an informed consent, prior to screening. For adolescent
subjects: informed assent signed by adolescents and informed consent signed by the
parent(s) or legally acceptable representative(s) as per local requirements.

7. Applicable for HIV-positive individuals only if:

They are medically stable at screening, as determined by the investigator, and free of
opportunistic infections in the 1 year prior to first study vaccination, and They have an
HIV-1 viral load <1000 copies/mL within 45 days of randomization in the study, and They are
receiving highly active antiretroviral therapy (HAART) for at least 3 months before
screening. Changes in antiretroviral dosage within 3 months of entering the study are
allowed, as are exchanges in pharmacological formulations.

Exclusion Criteria:

1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR*
or Rapid COVID-19 Antigen test) at screening or within 14 days prior to enrollment.

2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse)
in the opinion of the investigator.

3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or
history of Guillian-Barré syndrome.

4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic
agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or
planned receipt during the study period.

5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during
the study period.

6. Individuals who have a history of severe adverse reaction associated with a vaccine or
severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine
(SCB-2019, CpG1018 Adjuvant and Aluminum hydroxide components).

7. Individuals who have a history of malignancy within 1 year before screening
(exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ
of the cervix which have been cured, or other malignancies with minimal risk of
recurrence).

8. Individuals who have received any other investigational product within 30 days prior
to Day 1 or intent to participate in another clinical study at any time during the
conduct of this study.

9. Individuals who have received previous vaccination with any coronavirus vaccine.

10. Individuals who have received any other licensed vaccines within 14 days prior to
enrollment in this study or who are planning to receive any vaccine up to 14 days
after the second vaccination.

11. Individuals with known bleeding disorder that would, in the opinion of the
investigator, contraindicate intramuscular injection.

12. Individuals who received any blood/plasma products or immunoglobulins within 60 days
prior to Day 1 or plan to receive it during the study period.

13. Individuals with any condition that, in the opinion of the investigator, may increase
the risk of study participation or interfere with the assessment of the primary study
objectives.

14. Individuals with fever >37.8°C (irrespective of method), or any acute illness at
baseline (Day 1) or within 3 days of randomization.