Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
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
1 other identifier
interventional
528
1 country
1
Brief Summary
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.
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 Jul 2021
Longer than P75 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
Study Start
First participant enrolled
July 31, 2021
CompletedFirst Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedApril 19, 2023
April 1, 2023
9 months
August 2, 2021
April 18, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies
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
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
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
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
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
GMFR of serum IgG antibodies from before vaccination to each subsequent time point
56 days
Secondary Outcomes (5)
Percentage of participants reporting adverse events (AEs)
From dose 1 through 28 days after the last dose
Percentage of participants reporting solicited AEs
For 7 days after dose 1 and dose 2
Percentage of participants reporting unsolicited AEs
From dose 1 through 28 days after the last dose
Percentage of participants reporting serious adverse events (SAEs)
From dose 1 through 12 months after the last dose
Percentage of participants reporting adverse events of special interest (AESIs)
From dose 1 through 12 months after the last dose
Study Arms (8)
Adult Group 2a
EXPERIMENTALAdult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low adjuvant dose at Day 0 and Day 28
Adult Group 2b
EXPERIMENTALAdult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low antigen dose at Day 0 and Day 28
Adult Group 2c
EXPERIMENTALAdult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28.
Adult Placebo
PLACEBO COMPARATORAdult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28
Elderly Group 2d
EXPERIMENTALAdult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28
Elderly Group 2e
EXPERIMENTALAdult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28
Elderly Group 2f
EXPERIMENTALAdult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28
Elderly Placebo
PLACEBO COMPARATORAdult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28
Interventions
standard dose of 202-CoV with low dose CpG / alum adjuvant
low dose of 202-CoV with CpG / alum adjuvant
standard dose 202-CoV with CpG / alum adjuvant
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangcheng Center for Disease Control and Prevention
Xuchang, China
Related Publications (1)
Liu H, Zhou C, An J, Song Y, Yu P, Li J, Gu C, Hu D, Jiang Y, Zhang L, Huang C, Zhang C, Yang Y, Zhu Q, Wang D, Liu Y, Miao C, Cao X, Ding L, Zhu Y, Zhu H, Bao L, Zhou L, Yan H, Fan J, Xu J, Hu Z, Xie Y, Liu J, Liu G. Development of recombinant COVID-19 vaccine based on CHO-produced, prefusion spike trimer and alum/CpG adjuvants. Vaccine. 2021 Nov 26;39(48):7001-7011. doi: 10.1016/j.vaccine.2021.10.066. Epub 2021 Oct 30.
PMID: 34750014DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 4, 2021
Study Start
July 31, 2021
Primary Completion
April 22, 2022
Study Completion
November 1, 2023
Last Updated
April 19, 2023
Record last verified: 2023-04