Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)
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
1 other identifier
interventional
480
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Mar 2021
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2021
CompletedStudy Start
First participant enrolled
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMarch 31, 2022
March 1, 2022
1.4 years
March 19, 2021
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The positive conversion rate of anti-SARS-CoV-2 specific neutralizing antibody (eucivirus neutralization assays)
30 days after full-course vaccination in each study group
The incidence of adverse reaction (AR)
0 to 7 days after vaccination in each study group
Secondary Outcomes (9)
The incidence of adverse events (AE)
0 to 30 days after 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 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
- +4 more secondary outcomes
Other Outcomes (4)
The geometric mean titer (GMT) ratio of the SARS-CoV-2 neutralizing antibody and the S-RBD protein specific antibody in each study groups
14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
Subtypes of IgG antibodies against the S-RBD protein of SARS-CoV-2 after immunization in each study group
14 days, 30days, 6 months and 12 months after full-course vaccination in each study group
The proportion of IFN-γ secreted by T cells at Day 14 using ELISpot detection method
Day 14 after full-course vaccination in each study group
- +1 more other outcomes
Study Arms (8)
Middle-dose vaccine (18-59 years)
EXPERIMENTALThree doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56
High-dose vaccine (18-59 years)
EXPERIMENTALTwo doses of High-dose vaccine at the schedule of day 0, 28, 56
Middle-dose vaccine (60-85 years)
EXPERIMENTALThree doses of middle-dose experimental vaccine at the schedule of day 0, 28, 56
High-dose vaccine (60-85 years)
EXPERIMENTALTwo doses of High-dose experimental vaccine at the schedule of day 0, 28, 56
Middle-dose placebo (18-59 years)
PLACEBO COMPARATORThree doses of middle-dose placebo at the schedule of day 0, 28, 56
High-dose placebo (18-59 years)
PLACEBO COMPARATORTwo doses of High-dose placebo at the schedule of day 0, 28, 56
Middle-dose placebo (60-85 years)
PLACEBO COMPARATORThree doses of middle-dose placebo at the schedule of day 0, 28, 56
High-dose placebo (60-85 years)
PLACEBO COMPARATORTwo doses of High-dose placebo at the schedule of day 0, 28, 56
Interventions
18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
- Subjects with severe chronic diseases, severe cardiovascular diseases, hypertension(sbp≥160mmHg and/or dbp≥100mmHg) and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.
- Subjects with severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
- Subjects with thyroid disease or history of thyroidectomy, no spleen, functional asthenia, and any spleen or splenectomy caused by any condition.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Related Publications (1)
Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016.
PMID: 36103390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Doctor
Jiangsu Provincial Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2021
First Posted
March 24, 2021
Study Start
March 23, 2021
Primary Completion
July 30, 2022
Study Completion
July 30, 2022
Last Updated
March 31, 2022
Record last verified: 2022-03