A Single-center, Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells), in the Subjects From Healthy Aged 18 to 85 Years Old
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Locations
- 1
- Primary Endpoint
- The incidence of adverse reaction (AR)
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a phase Ⅱb, 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 18-59 and 60-85 years) with immunization procedures 0, 21, 42 days and doses 40μg.
Detailed Description
This is a phase Ⅱb, 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 18-59 and 60-85 years) . The phase Ⅱb clinical trials designed two research group, including adults group (aged 18-59 years) and elderly adults group (aged 60-85 years). Each group including 2000 participants. Vaccination or placebo group will be randomly assigned to receive in a 3:1 ratio, 4000 in total.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18-85 years old
- •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 14 months).
- •Axillary temperature ≤37.0℃
Exclusion Criteria
- •Positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS-CoV-
- •SARS-CoV-2 nucleic acid testing positive.
- •History of SARS-CoV-2 infection or vaccination
- •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 14 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.
Outcomes
Primary Outcomes
The incidence of adverse reaction (AR)
Time Frame: 0 to 7 days after each dose
The incidence of adverse reaction (AR)
The incidence of Adverse Events of Special Interest (AESI)
Time Frame: from day 0 to day 60 after last dose
The incidence of Adverse Events of Special Interest (AESI)
Secondary Outcomes
- The incidence of adverse events (AE)(from day 0 to day 30 after last dose)
- The incidence of severe adverse events (SAE)(Month 12 after the whole process of vaccination)
- Geometric mean (GMT) of specific antibody(day 30, day 60, month 6, month 12 after last dose)
- The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody(day 30, day 60, month 6, month 12 after last dose)
- Geometric mean (GMT) of anti-SARS-CoV-2-specific neutralizing antibodies(day 30, day 60, month 6, month 12 after last dose)
- The incidence of grade 3 adverse events (AE)(from day 0 to day 30 after last dose)
- Geometric mean fold increase (GMI) of S-RBD protein-specific antibody(day 30, day 60, month 6, month 12 after last dose)
- The positive conversion rate of S-RBD protein-specific antibody(day 30, day 60, month 6, month 12 after last dose)
- Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibodies(day 30, day 60, month 6, month 12 after last dose)