COVID-19
Conditions
Keywords
Safety, Immunogenicity, COVID-19 Vaccine, Recombinant vaccine
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALLow-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.
BIOLOGICALLow-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.
BIOLOGICALHigh-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.
BIOLOGICALHigh-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.
BIOLOGICALLow-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.
BIOLOGICALLow-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.
BIOLOGICALHigh-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.
BIOLOGICALHigh-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.
BIOLOGICALLow-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.
BIOLOGICALLow-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.
BIOLOGICALHigh-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.
BIOLOGICALHigh-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.
BIOLOGICALLow-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.
BIOLOGICALLow-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.
BIOLOGICALHigh-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.
BIOLOGICALHigh-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.
Sponsors
West China Hospital
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean (GMT) of specific antibody | 1 months after immunization in each study group | Geometric mean (GMT) of specific antibody against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike protein Receptor-binding domain(S-RBD) protein (ELISA) |
| The incidence of adverse reaction (AR) | 0 to 7 days after vaccination in each study group | The incidence of adverse reaction (AR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe adverse events (SAE) | 0 to 28 days after vaccination in each study group | The incidence of severe adverse events (SAE) |
| The incidence of serious adverse events | 6 months after vaccination in each study group | The incidence of serious adverse events |
| Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies | 1 months after immunization in each study group | Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies (euvirus and pseudovirus-neutralizing assays) |
| The positive conversion rate of S-RBD protein-specific antibody | 14 days, 30 days after immunization in each study group | The positive conversion rate of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2 |
| Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies | 14 days, 30 days after immunization in each study group | Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies (eucivirus and pseudovirus neutralization assays) |
| Geometric mean fold increase (GMI) of S-RBD protein-specific antibody | 14 days, 30 days after immunization in each study group | Geometric mean fold increase (GMI) of S-RBD protein-specific antibody (ELISA) against SARS-CoV-2 |
| The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody | 14 days, 30 days after immunization in each study group | The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization test) |
| The incidence of adverse events (AE) | 0 to 28 days after vaccination in each study group | The incidence of adverse events (AE) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subtypes of immunoglobulin G (IgG) antibodies | 1 months after immunization in each study group | Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group |
| The consistency analysis of the specific antibody and the specific neutralizing antibody | 1 months after immunization in each study group | The consistency analysis of the specific antibody (ELISA) and the specific neutralizing antibody (euvirus and pseudovirus neutralization assays) against SARS-CoV-2 S-RBD protein |
| The persistence (GMT，GMI，positive conversion rate) of specific antibodies | 6 months after vaccination in each study group | The persistence (GMT，GMI，positive conversion rate) of specific antibodies against SARS-CoV-2 S-RBD protein |
| The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody | 1 months after immunization in each study group | The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups |
Countries
China
Outcome results
None listed