- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04990544
Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
April 18, 2023 updated by: Shanghai Zerun Biotechnology Co.,Ltd
A Randomized, Double-blinded, Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for the Prevention of COVID-19 in Adults Aged 18 Years and Above
The purpose of this double-blind, randomized, controlled study is to assess immunogenicity and safety of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
528
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Xuchang, China
- Xiangcheng Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required).
- Willing to participate in the study with informed consent prior to screening
- Negative in SARS-CoV-2 IgG and IgM test at screening.
- Women of childbearing potential must be using effective method of birth control for 14 days prior to the enrollment of the study and must agree to continue such precautions during the study until 30 days after the second dose of the study vaccine/placebo.
- Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 30 days after the second dose of the study vaccine/placebo.
Exclusion Criteria:
- Confirmed or asymptomatic COVID-19 cases or SARS-CoV-2 infection(had positive in SARS-CoV-2 nucleic acid test or serological test).
- Had a history of traveling or residence in domestic area of high pandemic risk, overseas or epidemic areas, or had a history of contact with confirmed, asymptomatic or suspected COVID-19 cases within the past 14 days;
- History of SARS;
- Received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
- Individuals involving a clinical study within 6 months prior to the screening visit; or planning to participate in another clinical study during study period.
- Individual's systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg at screening visit
- Axillary temperature >=37.3℃ prior to vaccination
- Individuals in other acute diseases, or in the acute phase of chronic diseases within 3 days prior to the signing of the informed consent form.
- Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
- Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS-CoV-2 infection and/or its complications as judged by the investigator.
- Individuals with a history of severe allergic reaction (throat swelling, difficult in breath, dyspnea, or shock).
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction [e.g., anaphylaxis to any component of the study vaccines (S protein, Aluminum hydroxide, CpG adjuvant).
- Any autoimmune or immunodeficiency disease/condition [e.g. human immunodeficiency virus (HIV) infection, Systemic lupus erythematosus (SLE)]
- Received immunoglobulin, blood-derived products within 3 months prior to the first study vaccination.
- Abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) obvious bruises or coagulopathy.
- Pregnant women or breastfeeding women.
- According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adult Group 2a
Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low adjuvant dose at Day 0 and Day 28
|
standard dose of 202-CoV with low dose CpG / alum adjuvant
|
Experimental: Adult Group 2b
Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low antigen dose at Day 0 and Day 28
|
low dose of 202-CoV with CpG / alum adjuvant
|
Experimental: Adult Group 2c
Adult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28.
|
standard dose 202-CoV with CpG / alum adjuvant
|
Placebo Comparator: Adult Placebo
Adult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28
|
Normal saline solution
|
Experimental: Elderly Group 2d
Adult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28
|
standard dose of 202-CoV with low dose CpG / alum adjuvant
|
Experimental: Elderly Group 2e
Adult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28
|
low dose of 202-CoV with CpG / alum adjuvant
|
Experimental: Elderly Group 2f
Adult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28
|
standard dose 202-CoV with CpG / alum adjuvant
|
Placebo Comparator: Elderly Placebo
Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28
|
Normal saline solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies
Time Frame: 56 days
|
Neutralizing antibody activity as detected by neutralization assay expressed as GMTs at multiple time points through Day 56
|
56 days
|
Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies
Time Frame: 56 days
|
Neutralizing antibody activity as detected by neutralization assay expressed as seroconversion rate at multiple time points through Day 56
|
56 days
|
Geometric mean titer (GMT) of serum IgG antibodies
Time Frame: 56 days
|
Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as GMTs at multiple time points through Day 56
|
56 days
|
Seroconversion rate (SCR) of serum IgG antibodies
Time Frame: 56 days
|
Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as seroconversion rate at multiple time points through Day 56
|
56 days
|
Geometric mean fold rise (GMFR) of SARS-CoV-2 neutralising antibodies
Time Frame: 56 days
|
GMFR in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point
|
56 days
|
Geometric mean fold rise (GMFR) of serum IgG antibodies
Time Frame: 56 days
|
GMFR of serum IgG antibodies from before vaccination to each subsequent time point
|
56 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of participants reporting adverse events (AEs)
Time Frame: From dose 1 through 28 days after the last dose
|
Percentage of participants with solicited AEs (local, systemic) for 28 days following each primary vaccination (Days 0, 28) by intensity, relevance.
|
From dose 1 through 28 days after the last dose
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Percentage of participants reporting solicited AEs
Time Frame: For 7 days after dose 1 and dose 2
|
Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.
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For 7 days after dose 1 and dose 2
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Percentage of participants reporting unsolicited AEs
Time Frame: From dose 1 through 28 days after the last dose
|
Percentage of participants with unsolicited AEs for 28 days following each vaccination
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From dose 1 through 28 days after the last dose
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Percentage of participants reporting serious adverse events (SAEs)
Time Frame: From dose 1 through 12 months after the last dose
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Percentage of participants with SAEs from dose 1 through 12month after last dose vaccination
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From dose 1 through 12 months after the last dose
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Percentage of participants reporting adverse events of special interest (AESIs)
Time Frame: From dose 1 through 12 months after the last dose
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Percentage of participants with AESI from dose 1 through 12month after last dose vaccination
|
From dose 1 through 12 months after the last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2021
Primary Completion (Actual)
April 22, 2022
Study Completion (Anticipated)
November 1, 2023
Study Registration Dates
First Submitted
August 2, 2021
First Submitted That Met QC Criteria
August 2, 2021
First Posted (Actual)
August 4, 2021
Study Record Updates
Last Update Posted (Actual)
April 19, 2023
Last Update Submitted That Met QC Criteria
April 18, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202-COV-1002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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