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AzTrials

COVID-19 PandemicPhase 3COVID-19NCT05096832

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

A Phase 3 study testing Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) and Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in people with COVID-19 Pandemic, run by Livzon Pharmaceutical Group Inc. at 18 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic
What is being tested?
Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) and Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,381 participants
Where
18 sitesin 2 countries
Study dates
3 Nov 2021to 14 Apr 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Suspected or known alcohol or drug dependence.
  • History of severe psychiatric disorders which may affect study participation.
  • 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.
  • Those considered by the investigator as inappropriate to participate in the study.

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

Malaysia10 sites

  • Sunway Medical Centre Velocity (SMCV) Cheras

    Kuala Lumpur

  • Sarawak General Hospital

    Kuching, Sarawak

  • Hospital Pakar Sultanah Fatimah

    Muar town

  • Sunway Medical Centre (SunMed)

    Petaling Jaya

  • Hospital Pulau Pinang

    Pulau Pinang

  • Klinik Kesihatan Seremban 2

    Seremban

  • Seri Manjung Hospital

    Seri Manjung

  • Hospital Sibu

    Sibu

  • Hospital Sultan Abdul Halim

    Sungai Petani

  • Hospital Taiping

    Taiping

Other trials in Malaysia

Pakistan8 sites

  • Central Hospital Gujranwala

    Gujranwala, 52250

  • Shifa International Hospitals

    Islamabad, 44000

  • Aga Khan University Hospital

    Karachi, 74200

  • Dow University Hospital

    Karachi, 74200

  • Sindh Infectious Diseases Hospital & Research Center

    Karachi, 74200

  • Al Khidmat Foundation - Surraya Azeem Waqf Hospital

    Lahore, 54660

  • Avicenna Dental College

    Lahore, 54660

  • Central Park Medical College and Hospital

    Lahore, 54660

Other trials in Pakistan

About this study

Official title: 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

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

Read the detailed description

This is a global, multicenter, randomized, double-blind, placebo-controlled phase III clinical study. Approximately 10,722 participants aged 18 years and older who have completed the 2 doses of administration of inactive vaccines (BBIBP-CorV or CoronaVac) will be enrolled in this study to evaluate the efficacy, safety and immunogenicity of V-01.

The eligible participants will be randomly assigned to receive dose of either 10 μg V-01 or a placebo in a 1:1 randomization ratio. Assignment will be stratified by age (18-59 years vs. ≥ 60 years), gender (male vs. female), whether or not being enrolled into immunogenicity subgroup (yes vs no), and the types of inactivated vaccines (BBIBP-CorV vs. CoronaVac).

Being tested
Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01), Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
Keywords
V-01 Booster
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called V-01

    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

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

    Also called Placbo

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

Study groups in NCT05096832
Study groupRoleWhat they receive
V-01 COVID-19 VaccineExperimental1 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).
Receives: Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)
Placebo controlPlacebo comparator1 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).
Receives: Biological: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. The incidence of adverse events (AEs)

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

    Measured: Within 28 days after the booster vaccination

Secondary outcomes (7)

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

    To evaluate the relative vaccine efficacy of V-01 as a booster to prevent severe or above COVID-19 compared with the placebo control group.

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

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

    To evaluate the relative vaccine efficacy of V-01 as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity) in different age subgroups compared with the placebo control group.

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

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

    To evaluate the relative vaccine efficacy of V-01 as a booster to prevent suspected but not confirmed COVID-19 compared with the placebo control group.

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

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

    To evaluate the relative vaccine efficacy of V-01 as a booster to prevent death caused by COVID-19 compared with the placebo control group.

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

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

    To evaluate the relative vaccine efficacy of V-01 as a booster to prevent hospitalization caused by COVID-19 compared with the placebo control group.

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

  6. 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) within 12 months after the booster vaccination.

    Measured: Within 12 months after the booster vaccination

  7. The seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, GMT and GMI (Immunology Subgroup Only)

    To evaluate the immunogenicity of V-01.

    Measured: At day 14, day 28, month 3, month 6, and month 12 after immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start3 Nov 2021
  3. Primary completion18 Feb 2022
  4. Study completion14 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10,381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096832
Sponsor's protocol ID
TG2102V01
Acronym
COVID-19
Status last verified
Apr 2023
First submitted
21 Oct 2021
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35686572

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) and Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in people with COVID-19 Pandemic, run by Livzon Pharmaceutical Group Inc. at 18 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Malaysia, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From 15days after the administration of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-courseimmunization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096832, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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