A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱ Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 Years and Above
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Enrollment
- 960
- Locations
- 1
- Primary Endpoint
- Geometric mean (GMT) of specific antibody
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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-
- •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.
Outcomes
Primary Outcomes
Geometric mean (GMT) of specific antibody
Time Frame: 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)
Time Frame: 0 to 7 days after vaccination in each study group
The incidence of adverse reaction (AR)
Secondary Outcomes
- The incidence of adverse events (AE)(0 to 28 days after vaccination in each study group)
- The incidence of severe adverse events (SAE)(0 to 28 days after vaccination in each study group)
- The incidence of serious adverse events(6 months after vaccination in each study group)
- Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies(14 days after immunization in each study group)
- The positive conversion rate 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(14 days, 30 days after immunization in each study group)
- The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody(14 days, 30 days after immunization in each study group)
- Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies(14 days, 30 days after immunization in each study group)