A Single-center, Randomized, Double Blinded, Placebo Controlled, Phase 2 Clinical Trial of Recombinant COVID-19 Vaccine (CHO 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
- 480
- Locations
- 1
- Primary Endpoint
- The incidence of adverse reaction (AR)
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a phase Ⅱ, randomized, placebo-controlled, double-blind study, to evaluate immunogenicity and safety of a recombinant COVID-19 vaccine (CHO cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with an immunization procedure (0, 28, 56 days).
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 (CHO 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 4 research group, including an immunization procedures (0, 28, 56 days), two doses (20μg/0.5ml, 40μg/0.5ml) 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, 480 in total. Cellular immune blood samples were collected from the top 96 subjects (i.e., the top 24 in each study group, vaccine group: control group =5:1), and Elispot test and cytokine staining (ICS)/flow assay were performed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects of ≥ 18 years old.
- •The subject can understand and voluntarily sign the informed consent.
- •Axillary temperature ≤37.0℃.
- •General good health as established by medical history and physical examination
Exclusion Criteria
- •Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
- •Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
- •Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
- •In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
- •Have a history of SARS.
- •Have a history of SARS-CoV-2 infection or history of Coronavirus Vaccination (including Emergency Vaccine and Experimental Vaccine).
- •Positive in SARS-CoV-2 IgG or IgM antibody screening.
- •Have a history of HIV infection;
- •Women who are breastfeeding, pregnant, or planning to become pregnant during 6 months after full-course vaccination (based on the subject's self-report and blood pregnancy test results for women of childbearing age).
- •Have a history of asthma, a history of vaccine or vaccine component allergy, have serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
Outcomes
Primary Outcomes
The incidence of adverse reaction (AR)
Time Frame: 0 to 7 days after vaccination in each study group
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
Time Frame: 30 days after full-course vaccination in each study group
Secondary Outcomes
- The GMI of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody(14 days, 30days, 6 months and 12 months after full-course vaccination in each study group)
- The GMT of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody(14 days, 30days, 6 months and 12 months after full-course vaccination in each study group)
- The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (pseudovirus neutralization assays)(14 days, 30days, 6 months and 12 months after full-course vaccination in each study group)
- The Geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)(14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group)
- The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)(14 days, 6 months and 12 months after full-course vaccination in each study group)
- The positive conversion rate of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody(14 days, 30days, 6 months and 12 months after full-course vaccination in each study group)
- The incidence of severe adverse events (SAE)(12 months after prime and boost vaccination)
- The Geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (euvirus and pseudovirus neutralization assays)(14 days, 30 days, 6 months and 12 months after full-course vaccination in each study group)
- The incidence of adverse events (AE)(0 to 30 days after vaccination in each study group)