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Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05096845
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Livzon Pharmaceutical Group Inc.

Brief Summary:
A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older

Condition or disease Intervention/treatment Phase
COVID-19 Pandemic Biological: Recombinant SARS-CoV-2 fusion protein vaccine (V-01) Other: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase 3

Detailed Description:

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III clinical study. Approximately 22,500 participants aged 18 years and older will be enrolled in this study to evaluate the efficacy, safety and immunogenicity of recombinant SARS-CoV-2 fusion protein vaccine (code: V-01, hereinafter referred to as V-01).

The eligible participants will be randomized in a 2:1 ratio into investigational vaccine group (V-01) and placebo group, with random stratification factors including 1) age (18-59 years vs ≥60 years); 2) gender (male vs female); and 3) whether or not being enrolled into immunogenicity subgroup (yes vs no). The participants will receive investigational vaccine V-01 or placebo on two doses schedule (one dose each on day 0 and 21, with +7 days' time window for the second dose).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
Actual Study Start Date : August 25, 2021
Estimated Primary Completion Date : March 2, 2023
Estimated Study Completion Date : April 22, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: V-01 COVID-19 Vaccine
Intramuscular injection into the lateral deltoid of the upper arm Two doses, one each on Day 0 and 21 (+7 days), respectively.
Biological: Recombinant SARS-CoV-2 fusion protein vaccine (V-01)

Appearance: creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5mL) /vial Vaccination route: intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg Immunization schedule: two doses, one each on Day 0 and 21 (+7 days), respectively.

Storage condition: store at 2~8°C protected from light Expiry date: 24 months after production date

Other Name: V-01

Placebo Comparator: Placebo control
Intramuscular injection into the lateral deltoid of the upper arm Two doses, one each on Day 0 and 21 (+7 days), respectively.
Other: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.




Primary Outcome Measures :
  1. The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) [ Time Frame: More than 14 days (≥15 days) after full course immunization ]
    To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above severity) starting from at least 14 days (≥15 days) after full-course immunization (completing all vaccinations);

  2. The incidence of adverse events (AEs) of V-01 [ Time Frame: From the first vaccination to 28 days after full-course immunization ]
    To evaluate the incidence of adverse events (AEs) of recombinant SARS-CoV-2 fusion protein vaccine (V-01) from the first vaccination to 28 days after full-course immunization


Secondary Outcome Measures :
  1. The efficacy of V-01 for the prevention of COVID-19 of severe or above in severity [ Time Frame: More than 14 days (≥15 days) after full-course immunization; ]
    To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of COVID-19 of severe or above severity starting from at least 14 days (≥15 days) after full-course immunization;

  2. The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) [ Time Frame: More than 14 days (≥15 days) after full-course immunization; ]
    To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) starting from more than 14 days after the first vaccination;

  3. The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) in different age groups [ Time Frame: More than 14 days (≥15 days) after full-course immunization; ]
    To evaluate the efficacy of the recombinant SARS-CoV-2 fusion protein vaccine (V-01) for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) starting from more than 14 days after full-course immunization in different age groups

  4. The morbidity of suspected but not confirmed COVID-19 (negative or not detected) [ Time Frame: More than 14 days (≥15 days) after full-course immunization; ]
    To evaluate the morbidity of suspected but not confirmed COVID-19 (negative or not detected)

  5. The mortality caused by COVID-19 [ Time Frame: More than 14 days (≥15 days) after full-course immunization; ]
    To evaluate the mortality caused by COVID-19

  6. The hospitalization rate caused by COVID-19 [ Time Frame: More than 14 days (≥15 days) after full-course immunization; ]
    To evaluate the hospitalization rate caused by COVID-19

  7. The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) [ Time Frame: From the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization ]
    To evaluate the incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) occurred from the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization

  8. The seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI) [ Time Frame: At day 28, month 3, month 6, and month 12 after full-course immunization ]
    1. To evaluate the seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI) at day 28, month 3, month 6, and month 12 after full-course immunization (enzyme-linked immunosorbent assay [ELISA]);
    2. To evaluate the seroconversion rate of serum anti-SARS-CoV-2 neutralizing antibody, GMT and GMI at day 28, month 3, month 6, and month 12 after full-course immunization (live virus neutralization assay);


Other Outcome Measures:
  1. The severity of COVID-19, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE) [ Time Frame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization ]
    To evaluate the severity of COVID-19 of participants in the vaccine group versus the control group, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE)

  2. The correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases [ Time Frame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization ]
    To explore the correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases.

  3. SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases [ Time Frame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization ]
    Genotypic analyses of SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases.

  4. The immunogenicity of V-01 against new SARS-CoV-2 variants [ Time Frame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization ]
    To explore the immunogenicity of V-01 against new SARS-CoV-2 variants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

The participants can be enrolled only all of the following criteria are met:

  1. Voluntarily participate in this study and sign the informed consent form;
  2. Adults aged 18 years and older, male or female;
  3. According to the assessment of the investigator, the participant has a stable medical condition (which is defined as no significant changes in therapy or hospitalization caused by disease aggravation within 3 months before enrollment) and is able to and willing to follow the requirements of the protocol.
  4. Males of reproductive potential and females of child-bearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 12 months after full-course immunization; females of child-bearing potential have a negative pregnancy test at screening and at the day of vaccination.

Exclusion Criteria:

Participants meeting any of the following exclusion criteria will not be allowed to participate in this study:

1.History of previous COVID-19 infection; 2.Positive result for RT-PCR test in the screening period or specific antibody IgG or IgM meet the following criteria:

  1. If IgG is positive, the participant will be excluded regardless of the results of other indexes.
  2. If IgG is negative and IgM is positive, it will be determined whether or not to enroll such participant after the result of RT-PCR test is obtained;
  3. If both IgG and IgM are negative, the participant can be vaccinated without waiting for the RT-PCR test results.

3.History of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS), and other human coronavirus infections or diseases; 4.History of severe allergy to any vaccine, e.g., acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain etc., or be allergic to any components of V-01; 5.Any confirmed or suspected immunosuppression or immunodeficiency condition known from medical history, including human immunodeficiency virus (HIV) infection, asplenia; 6.Serious or uncontrolled cardiovascular diseases, nervous system disorders (e.g., Guillain-Barre syndrome), blood and lymphatic system disorders, immune system disorders, hepatorenal disorders, respiratory system disorders (e.g., active tuberculosis, pulmonary fibrosis), metabolic and skeletal systems disorders or malignant tumors (except for skin basal cell carcinoma or in situ carcinoma of uterine cervix that has been cured for more than 5 years); 7.Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic disease, or requirement of continuous use of anticoagulants; 8.Prior use of any medications to prevent COVID-19, e.g., use of antipyretics without pyrexia and any other symptoms; 9.A history of vaccination against SARS-CoV-2 (marketed or investigational); 10.Received attenuated live vaccine within 28 days before the first vaccination or any other vaccines (licensed or investigational) within 14 days before the first vaccination; 11.Injection of immunoglobulin and/or other blood products within 3 months before the administration of study vaccine; 12.Long-term use (continuous use >14 days) of glucocorticoids (≥10mg/day of prednisone or its equivalent dose) or other immunosuppressive agents; however, enrollment is allowed for the following conditions: inhaled or topical use of topical steroids, or short-term use (treatment course ≤14 days) of oral steroids; 13.Pregnant or breastfeeding women; 14.Planning to donate blood during the study period; 15.Suspected or known alcohol or drug dependence; 16.History of severe psychiatric disorders which may affect study participation; 17.Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits, so that the scheduled visits cannot be followed; 18.Those considered by the investigator as inappropriate to participate in the study.


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): NCT05096845


Contacts
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Contact: Yang Jiaming, Dr. 86-756-7238289 yangjiaming@livzon.cn

Locations
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Sponsors and Collaborators
Livzon Pharmaceutical Group Inc.
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Responsible Party: Livzon Pharmaceutical Group Inc.
ClinicalTrials.gov Identifier: NCT05096845    
Other Study ID Numbers: TG2101V01
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
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
Keywords provided by Livzon Pharmaceutical Group Inc.:
V-01
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs