This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).
This is a phase Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to
evaluate the immunogenicity and safety of the recombinant COVID-19 vaccine (Sf9 cells) in the
subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85
years) . The phase Ⅱ clinical trials designed 8 research group, including two immunization
procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages
group (adults and elder): Each group including 120 participants. Vaccination or placebo group
will be randomly assigned to receive in a 5:1 ratio, 960 in total.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen
18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen
18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen
60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
Biological: High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen
60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
Biological: Low-dose placebo (18-59 years) & Two dose regimen
18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Biological: Low-dose placebo (18-59 years) & Three dose regimen
18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
Biological: High-dose placebo (18-59 years) & Two dose regimen
18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
Biological: High-dose placebo (18-59 years) & Three dose regimen
18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
Biological: Low-dose placebo (60-85 years) & Two dose regimen
60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
Biological: Low-dose placebo (60-85 years) & Three dose regimen
60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
Biological: High-dose placebo (60-85 years) & Two dose regimen
60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
Biological: High-dose placebo (60-85 years) & Three dose regimen
60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
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.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Fengcai Zhu, Doctor, Principal Investigator
Jiangsu Provincial Center for Disease Control and Prevention