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

About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
Eligibility 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.
Sites / Locations
- Jiangsu Provincial Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Low-dose vaccine (18-59 years) & Two dose regimen
Low-dose vaccine (18-59 years) & Three dose regimen
High-dose vaccine (18-59 years) & Two dose regimen
High-dose vaccine (18-59 years) & Three dose regimen
Low-dose vaccine (60-85 years) & Two dose regimen
Low-dose vaccine (60-85 years) & Three dose regimen
High-dose vaccine (60-85 years) & Two dose regimen
High-dose vaccine (60-85 years) & Three dose regimen
Low-dose placebo (18-59 years) & Two dose regimen
Low-dose placebo (18-59 years) & Three dose regimen
High-dose placebo (18-59 years) & Two dose regimen
High-dose placebo (18-59 years) & Three dose regimen
Low-dose placebo (60-85 years) & Two dose regimen
Low-dose placebo (60-85 years) & Three dose regimen
High-dose placebo (60-85 years) & Two dose regimen
High-dose placebo (60-85 years) & Three dose regimen
two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
two doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
three doses of low-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
two doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
three doses of high-dose Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
two doses of placebo at the schedule of day 0, 21.
three doses of placebo at the schedule of day 0, 14, 28.
two doses of placebo at the schedule of day 0, 21.
three doses of placebo at the schedule of day 0, 14, 28.
two doses of placebo at the schedule of day 0, 21.
three doses of placebo at the schedule of day 0, 14, 28.
two doses of placebo at the schedule of day 0, 21.
three doses of placebo at the schedule of day 0, 14, 28.