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

NCT05096845 | Unknown Phase 3 DMC

• 1 other identifier: TG2101V01
• Study Type: interventional
• Target: 22,500
• Locations: 3 countries
• Sites: 25

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

Conditions

COVID-19 Pandemic

Keywords

V-01

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The efficacy of V-01 for the prevention of COVID-19 of severe or above in severity

  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)

  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

  More than 14 days (≥15 days) after full-course immunization;

• 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

  More than 14 days (≥15 days) after full-course immunization;

Other Outcomes (4)

• The severity of COVID-19, 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

  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

  From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization

Study Arms (2)

V-01 COVID-19 Vaccine

EXPERIMENTAL

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)

Placebo control

PLACEBO COMPARATOR

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)

Interventions

Recombinant SARS-CoV-2 fusion protein vaccine (V-01) BIOLOGICAL

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

Also known as: V-01

V-01 COVID-19 Vaccine

Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) OTHER

The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.

Placebo control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants can be enrolled only all of the following criteria are met:
• Voluntarily participate in this study and sign the informed consent form;
• Adults aged 18 years and older, male or female;
• 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.
• 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.

You may not qualify if:

• 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:
• If IgG is positive, the participant will be excluded regardless of the results of other indexes.
• 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;
• If both IgG and IgM are negative, the participant can be vaccinated without waiting for the RT-PCR test results.
• 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.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (25)

Andalas University Hospital

Padang, Indonesia

Location

Medical Faculty of Mulawarman University

Samarinda, Indonesia

Location

Medical Faculty of Padjadjaran University

Sumedang, Indonesia

Location

Medical Faculty of UIN Syarif Hidayatullah

Tangerang, Indonesia

Location

Mary Mediatrix Medical Center

Lipa City, Batangas, 4217, Philippines

Location

The Medical City- Iloilo

Iloilo City, Iloilo, 5000, Philippines

Location

Makati Medical Center

Makati City, Philippines

Location

University of the Philippines - Philippine General Hospital

Manila, 1000, Philippines

Location

East Avenue Medical Center

Manila, Philippines

Location

Lung Center of the Philippines

Manila, Philippines

Location

Mary Chiles General Hospital

Manila, Philippines

Location

Far Eastern University-Nicanor Reyes Medical Foundation Medical Center

Quezon City, 1118, Philippines

Location

St. Luke's Medical Foundation Medical Center

Quezon City, Philippines

Location

Central Clinical Hospital of the Russian Academy of Sciences

Engel's, Russia

Location

Oris LLC

Moscow, Russia

Location

Zvezdnaya Clinic

Moscow, Russia

Location

UZI-4D Clinic LLC

Pyatigorsk, Russia

Location

Institute of Medical Research LLC

Saint Petersburg, Russia

Location

Lab. of molecular virology Smorodintsev Research Institute of Influenza MoH

Saint Petersburg, Russia

Location

LLC "Uromed"

Saint Petersburg, Russia

Location

Medical Technologies

Saint Petersburg, Russia

Location

N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences

Saint Petersburg, Russia

Location

Research Center ECO Safety LLC

Saint Petersburg, Russia

Location

State Budgetary Healthcare Institution "Nikolaevskaya hospital"

Saint Petersburg, Russia

Location

Strategic Medical Systems LLC

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 27, 2021
• Study Start: August 25, 2021
• Primary Completion: February 8, 2022
• Study Completion: June 14, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

RU (12); ID (4); PH (9)