Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Study

NCT05096832 | Completed Phase 3 DMC

• 1 other identifier: TG2102V01
• Study Type: interventional
• Target: 10,381
• Locations: 2 countries
• Sites: 18

Brief Summary

A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity 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

Conditions

COVID-19 Pandemic

Keywords

V-01 Booster

Outcome Measures

Primary Outcomes (2)

• the relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity)

  To evaluate the relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and reverse transcription polymerase chain reaction (RT-PCR) positive COVID-19 (mild or above severity) compared with the placebo control group.

  From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization

• The incidence of adverse events (AEs)

  To evaluate the incidence of adverse events (AEs) within 28 days after the booster vaccination.

  Within 28 days after the booster vaccination

Secondary Outcomes (7)

• The relative vaccine efficacy of V-01 as a booster to prevent severe or above COVID-19

  From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization

• The relative vaccine efficacy of V-01 as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity)

  From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization

• The relative vaccine efficacy of V-01 as a booster to prevent suspected but not confirmed COVID-19

  From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization

• The relative vaccine efficacy of V-01 as a booster to prevent death caused by COVID-19

  From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization

• The relative vaccine efficacy of V-01 as a booster to prevent hospitalization caused by COVID-19

  From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization

Other Outcomes (2)

• The genotype of SARS-CoV-2 in symptomatic and RT-PCR positive COVID-19 cases.

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

• Immunogenicity of V-01 against new SARS-CoV-2 variants

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

Study Arms (2)

V-01 COVID-19 Vaccine

EXPERIMENTAL

1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac).

Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

Placebo control

PLACEBO COMPARATOR

1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac).

Biological: 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 (0.5 mL) /vial Vaccination route: Intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg (0.5 mL) Immunization schedule: 1 dose on Day 0, which should be 3-6 months after the second dose of 2-dose regimen of inactive vaccine (BBIBP-CorV or CoronaVac). Storage condition: Store at 2-8 °C protected from light Expiry date: 24 months temporarily

Also known as: V-01

V-01 COVID-19 Vaccine

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

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

Also known as: Placbo

Placebo control

Eligibility Criteria

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

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Voluntarily participate in the study and sign the informed consent form.
• Adults aged 18 years and older at time of consent, male or female.
• Able to and willing to comply with study procedure based on the assessment of the investigator.
• Participants who have completed the second dose of 2-dose regimen of inactive vaccination (BBIBP-CorV or CoronaVac) against SARS-CoV-2 in the past 3-6 months (Note: Participants who received mixed vaccination of BBIBP-CorV and CoronaVac will not be enrolled).
• Healthy participants or participants with pre-existing stable medical conditions (A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease within 3 months before enrollment).
• 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; and a female participant of childbearing potential should have a negative pregnancy test at screening and on the day of vaccination (day 0).
• Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause).

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• History of previous COVID-19 infection.
• Positive for SARS-CoV-2 test by RT-PCR during screening period (Note: Participants can be enrolled in the study and receive the investigational product without waiting for the report of the SARS-CoV-2 test by RT-PCR).
• History of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and other human coronavirus infections or diseases.
• 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.
• Any confirmed or suspected immunosuppression or immunodeficiency condition known from medical history, including human immunodeficiency virus (HIV) infection, asplenia.
• 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).
• Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic disease, or requirement of continuous use of anticoagulants.
• Prior use of any medication to prevent COVID-19 within 1 week before signing the informed consent form (except for previous vaccines, BBIBP-CorV or CoronaVac), e.g., use of antipyretics without pyrexia and any other symptoms.
• Received attenuated live vaccine within 28 days before the vaccination or any other vaccines (licensed or investigational) within 14 days before the vaccination.
• Has participated in an interventional clinical study within 1 months prior to the day of vaccination.
• Injection of immunoglobulin and/or other blood products within 3 months before the administration of study vaccine.
• Long-term use (continuous use \> 14 days) of glucocorticoids (≥ 10 mg/day of prednisone or its equivalent dose) or other immunosuppressive agents within 6 months before signing the informed consent form; 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.
• Pregnant or breastfeeding women.
• Planning to donate blood during the study period.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (18)

Sarawak General Hospital

Kuching, Sarawak, Malaysia

Location

Sunway Medical Centre Velocity (SMCV) Cheras

Kuala Lumpur, Malaysia

Location

Hospital Pakar Sultanah Fatimah

Muar town, Malaysia

Location

Sunway Medical Centre (SunMed)

Petaling Jaya, Malaysia

Location

Hospital Pulau Pinang

Pulau Pinang, Malaysia

Location

Klinik Kesihatan Seremban 2

Seremban, Malaysia

Location

Seri Manjung Hospital

Seri Manjung, Malaysia

Location

Hospital Sibu

Sibu, Malaysia

Location

Hospital Sultan Abdul Halim

Sungai Petani, Malaysia

Location

Hospital Taiping

Taiping, Malaysia

Location

Central Hospital Gujranwala

Gujranwala, 52250, Pakistan

Location

Shifa International Hospitals

Islamabad, 44000, Pakistan

Location

Aga Khan University Hospital

Karachi, 74200, Pakistan

Location

Dow University Hospital

Karachi, 74200, Pakistan

Location

Sindh Infectious Diseases Hospital & Research Center

Karachi, 74200, Pakistan

Location

Al Khidmat Foundation - Surraya Azeem Waqf Hospital

Lahore, 54660, Pakistan

Location

Avicenna Dental College

Lahore, 54660, Pakistan

Location

Central Park Medical College and Hospital

Lahore, 54660, Pakistan

Location

Related Publications (1)

• Wang XY, Mahmood SF, Jin F, Cheah WK, Ahmad M, Sohail MA, Ahmad W, Suppan VK, Sayeed MA, Luxmi S, Teo AH, Lee LY, Qi YY, Pei RJ, Deng W, Xu ZH, Yang JM, Zhang Y, Guan WX, Yu X. Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial. Emerg Microbes Infect. 2022 Dec;11(1):1910-1919. doi: 10.1080/22221751.2022.2088406.

  PMID: 35686572 DERIVED

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: November 3, 2021
• Primary Completion: February 18, 2022
• Study Completion: April 14, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

PA (8); MY (10)