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Phase II Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04990544
Recruitment Status : Active, not recruiting
First Posted : August 4, 2021
Last Update Posted : September 1, 2022
Sponsor:
Collaborator:
Walvax Biotechnology Co., Ltd.
Information provided by (Responsible Party):
Shanghai Zerun Biotechnology Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: 202-CoV low adjuvant dose Biological: 202-CoV low antigen dose Biological: 202-CoV standard dose Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1056 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 31, 2021
Actual Primary Completion Date : November 10, 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


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
Biological: 202-CoV low adjuvant dose
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
Biological: 202-CoV low antigen dose
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.
Biological: 202-CoV standard dose
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
Biological: Placebo
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
Biological: 202-CoV low adjuvant dose
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
Biological: 202-CoV low antigen dose
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
Biological: 202-CoV standard dose
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
Biological: Placebo
Normal saline solution




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: From dose 1 through 12 months after the last dose ]
    Percentage of participants with SAEs from dose 1 through 12month after last dose vaccination

  5. Percentage of participants reporting adverse events of special interest (AESIs) [ Time Frame: From dose 1 through 12 months after the last dose ]
    Percentage of participants with AESI from dose 1 through 12month after last dose vaccination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04990544


Locations
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China
Xiangcheng Center for Disease Control and Prevention
Xuchang, China
Sponsors and Collaborators
Shanghai Zerun Biotechnology Co.,Ltd
Walvax Biotechnology Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai Zerun Biotechnology Co.,Ltd
ClinicalTrials.gov Identifier: NCT04990544    
Other Study ID Numbers: 202-COV-1002
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases