Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III (COVID-19)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Biological: Recombinant SARS-CoV-2 fusion protein vaccine (V-01); Other: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 22500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Padang, Indonesia
    • Andalas University Hospital
  • Samarinda, Indonesia
    • Medical Faculty of Mulawarman University
  • Sumedang, Indonesia
    • Medical Faculty of Padjadjaran University
  • Tangerang, Indonesia
    • Medical Faculty of UIN Syarif Hidayatullah
• Philippines
  • Makati City, Philippines
    • Makati Medical Center
  • Manila, Philippines, 1000
    • University of the Philippines - Philippine General Hospital
  • Manila, Philippines
    • East Avenue Medical Center
  • Manila, Philippines
    • Lung Center of the Philippines
  • Manila, Philippines
    • Mary Chiles General Hospital
  • Quezon City, Philippines, 1118
    • Far Eastern University-Nicanor Reyes Medical Foundation Medical Center
  • Quezon City, Philippines
    • St. Luke's Medical Foundation Medical Center
  • Batangas
    • Lipa city, Batangas, Philippines, 4217
      • Mary Mediatrix Medical Center
  • Iloilo
    • Iloilo City, Iloilo, Philippines, 5000
      • The Medical City- Iloilo
• Russian Federation
  • Engels, Russian Federation
    • Central Clinical Hospital of the Russian Academy of Sciences
  • Moscow, Russian Federation
    • Oris LLC
  • Moscow, Russian Federation
    • Zvezdnaya Clinic
  • Pyatigorsk, Russian Federation
    • UZI-4D Clinic LLC
  • Saint Petersburg, Russian Federation
    • Institute of Medical Research LLC
  • Saint Petersburg, Russian Federation
    • Lab. of molecular virology Smorodintsev Research Institute of Influenza MoH
  • Saint Petersburg, Russian Federation
    • LLC "Uromed"
  • Saint Petersburg, Russian Federation
    • Medical Technologies
  • Saint Petersburg, Russian Federation
    • N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
  • Saint Petersburg, Russian Federation
    • Research Center ECO Safety LLC
  • Saint Petersburg, Russian Federation
    • State Budgetary Healthcare Institution "Nikolaevskaya hospital"
  • Saint Petersburg, Russian Federation
    • Strategic Medical Systems LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity)	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);	More than 14 days (≥15 days) after full course immunization
The incidence of adverse events (AEs) of V-01	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	From the first vaccination to 28 days after full-course immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of V-01 for the prevention of COVID-19 of severe or above in severity	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;	More than 14 days (≥15 days) after full-course immunization;
The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity)	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;	More than 14 days (≥15 days) after full-course immunization;
The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) in different age groups	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	More than 14 days (≥15 days) after full-course immunization;
The morbidity of suspected but not confirmed COVID-19 (negative or not detected)	To evaluate the morbidity of suspected but not confirmed COVID-19 (negative or not detected)	More than 14 days (≥15 days) after full-course immunization;
The mortality caused by COVID-19	To evaluate the mortality caused by COVID-19	More than 14 days (≥15 days) after full-course immunization;
The hospitalization rate caused by COVID-19	To evaluate the hospitalization rate caused by COVID-19	More than 14 days (≥15 days) after full-course immunization;
The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)	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	From the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization
The seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI)	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]);; 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);	At day 28, month 3, month 6, and month 12 after full-course immunization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of COVID-19, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE)	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)	From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
The correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases	To explore the correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases.	From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases	Genotypic analyses of SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases.	From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
The immunogenicity of V-01 against new SARS-CoV-2 variants	To explore the immunogenicity of V-01 against new SARS-CoV-2 variants	From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization

Collaborators and Investigators

• Sponsor: Livzon Pharmaceutical Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Actual): February 8, 2022
• Study Completion (Anticipated): June 14, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: V-01
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: TG2101V01

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