A Phase ? Clinical Trial of Recombinant Corona Virus Disease-19 (COVID-19) Vaccine (Sf9 Cells)

ABSTRACT

ConditionCOVID-19

InterventionBiological Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen;Biological Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen;Biological High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen;Biological High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen;Biological Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen;Biological Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen;Biological High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen;Biological High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen;Biological Low-dose placebo (18-59 years) & Two dose regimen;Biological Low-dose placebo (18-59 years) & Three dose regimen;Biological High-dose placebo (18-59 years) & Two dose regimen;Biological High-dose placebo (18-59 years) & Three dose regimen;Biological Low-dose placebo (60-85 years) & Two dose regimen;Biological Low-dose placebo (60-85 years) & Three dose regimen;Biological High-dose placebo (60-85 years) & Two dose regimen;Biological High-dose placebo (60-85 years) & Three dose regimen

Primary outcome:Geometric mean (GMT) of specific antibody;The incidence of adverse reaction (AR)

Criteria
Inclusion Criteria

- Aged 18 years and above.

- Able to understand the content of informed consent and willing to sign the informed
consent.

- Able and willing to complete all the secluded study process during the whole study
follow-up period (about 7 months).

- Axillary temperature =37.0?.

- General good health as established by medical history and physical examination.

Exclusion Criteria

First dose exclusion criteria

- Positive serum immunoglobulin M (IgM) and IgG to the SARS-CoV-2.

- A Known History of HIV infection

- Family history of seizure, epilepsy, brain or mental disease.

- Participant that has an allergic history to any ingredient of vaccines.

- Woman who is pregnant, breast-feeding or positive in pregnancy test on day of
enrollment, or is planning to be pregnant during the next 6 months.

- Any acute fever disease or infections.

- Have a medical history of SARS.

- Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial
infarction, severe hypertension and not well-controlled.

- Major chronic illness, such as asthma, diabetes, or thyroid disease, and not
well-controlled.

- Hereditary angioneurotic edema or acquired angioneurotic edema.

- Urticaria in last one year.

- Asplenia or functional asplenia.

- Platelet disorder or other bleeding disorder may cause injection contraindication.

- Faint at the sight of blood or needles.

- Prior administration of immunodepressant or corticosteroids, antianaphylactics
treatment, cytotoxic treatment in last 6 months.

- Prior administration of blood products in last 4 months.

- Prior administration of other research medicines in last 1 month.

- Prior administration of attenuated vaccine in last 1 month.

- Prior administration of subunit vaccine or inactivated vaccine in last 14 days.

- Being treated for tuberculosis.

- Any condition that in the opinion of the investigators may interfere with the
evaluation of study objectives.

Exclusion criteria for subsequent doses

- Patients with severe allergic reactions after the previous dose of vaccination;

- Patients with serious adverse events causally related to the previous dose of
vaccination.