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Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (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: NCT05238649
Recruitment Status : Active, not recruiting
First Posted : February 14, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

Tracking Information
First Submitted Date  ICMJE February 10, 2022
First Posted Date  ICMJE February 14, 2022
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE November 10, 2021
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2022)
Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies [ Time Frame: 28 days after booster immunization ]
The Geometric Mean Titers of SARS-CoV-2 neutralizing antibodies
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine
Official Title  ICMJE A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
Brief Summary A Randomized, Double Blind, Positive Control Clinical Study to Evaluate the Immunogenicity and Safety of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines
Detailed Description

This is a Randomized, Double Blind, Positive Control exploratory clinical study. 150 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines 6 months (±1 month) ago were enrolled in this study to evaluate the safety and immunogenicity of V-01.

The participants will be enrolled to test group A (V-01 10 μg), test group B (V-01 25 μg) and test group C (inactivated vaccine) by the ratio of 1:1:1. The participants received 1 dose of V-01 or inactivated vaccine base on the group.

The random stratification factor is age (18-59 years old vs. ≥ 60 years old).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19 Pandemic
Intervention  ICMJE
  • Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg
    The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
    Other Name: V-01 10μg
  • Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg
    The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
    Other Name: V-01 25μg
  • Biological: SARS-Cov-2 Vaccine Inactivated
    The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
    Other Name: Inactivated vaccine
Study Arms  ICMJE
  • Experimental: V-01 10 μg
    10 μg(0.5ml)/vial, one dose administrated by intramuscular injection
    Intervention: Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 10μg
  • Experimental: V-01 25 μg
    25 μg(0.5ml)/vial, one dose administrated by intramuscular injection
    Intervention: Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine 25μg
  • Active Comparator: Inactivated vaccine
    0.5ml/vial, containing 100U inactivated COVID-19 virus antigen. One dose administrated by intramuscular injection
    Intervention: Biological: SARS-Cov-2 Vaccine Inactivated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 10, 2022)
150
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 28, 2023
Estimated Primary Completion Date November 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy participants aged 18 years and older who have completed the second dose of 2-dose regimen of SARS-CoV-2 Inactivated Vaccine in the past 6 (±1) months;
  2. Voluntarily participate in the study and sign the informed consent form, who can provide valid ID and follow the study protocol requirement;
  3. In the past 14 days, no history of high or medium risk of the epidemic, overseas travel history or residence history; no history of contact with confirmed, asymptomatic or suspected COVID-19 cases; no history of contact with the persons from high- and medium-risk epidemic areas or contact patients with fever or respiratory symptoms; and those who are not in isolation period.
  4. Males of reproductive potential and females of childbearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 3 months after vaccination.

Exclusion Criteria:

1. Confirmed COVID-19 cases, or positive for SARS-CoV-2 test by RT-PCR. 2. History of previous SARS infection. 3. History of severe allergy to any vaccine or any ingredient of the vaccine including aluminum adjuvant, e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc.

4. People who currently suffer from the following diseases:

  1. Symptoms related to acute respiratory infections (such as: sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.)
  2. Patients with thrombocytopenia, any coagulation dysfunction, or receive anticoagulant treatment, etc.
  3. Patients with congenital or acquired angioedema/neuroedema;
  4. A history of congenital or acquired immunodeficiency or autoimmune disease (except for mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy); no spleen , or history of spleen surgery, history of trauma, or treatment with immunomodulators within 6 months, such as: glucocorticoid with the dose causing immunosuppressive (dose reference: equivalent to prednisone 20mg/day, more than one week); or monoclonal antibody ; or thymosin; or interferon, etc.; but local medication (such as ointment, eye drops, inhalation or nasal spray) is allowed.
  5. Patients with active tuberculosis, viral hepatitis, human immunodeficiency virus or syphilis infection.
  6. Patients with acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases: history of chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg) And/or diastolic blood pressure ≥100mmHg), history of severe cardiovascular disease (including heart failure, coronary artery disease, cardiomyopathy), history of chronic kidney disease, history of cancer (except for basal cell carcinoma), diabetes (unsatisfied blood sugar control or diabetes related serious complications).

5. Received inactivated vaccines or any subunit vaccines within 14 days before the vaccination and attenuated live vaccine within 28 days before the vaccination.

6. Injection of immunoglobulin and/or other blood products within 3 months before the administration of study vaccine; or with the plan to use such product within 6 month after immunization.

7. Pregnant (including positive urine pregnancy test for women of childbearing age) or breastfeeding women. Or women or their partners who have a pregnancy plan within 3 months after the trial vaccination.

8. Have participated in or are participating in other COVID-19 related clinical trials, or are participating in other drug clinical trials; 9. Those considered by the investigator as inappropriate to participate in the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05238649
Other Study ID Numbers  ICMJE ICV-V-01-Booster-A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Livzon Pharmaceutical Group Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Livzon Pharmaceutical Group Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ligong Lu, Dr. Zhuhai People's Hospital Medical Group
PRS Account Livzon Pharmaceutical Group Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP