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

COVID-19 Pandemic Clinical Trial

— COVID-19  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05096845
• Other study ID #: TG2101V01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 25, 2021
• Est. completion date: June 14, 2023

Study information

• Verified date: April 2023
• Source: Livzon Pharmaceutical Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22500
• Est. completion date: June 14, 2023
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

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:
• 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.

Locations

Country	Name	City	State
Indonesia	Andalas University Hospital	Padang
Indonesia	Medical Faculty of Mulawarman University	Samarinda
Indonesia	Medical Faculty of Padjadjaran University	Sumedang
Indonesia	Medical Faculty of UIN Syarif Hidayatullah	Tangerang
Philippines	The Medical City- Iloilo	Iloilo City	Iloilo
Philippines	Mary Mediatrix Medical Center	Lipa city	Batangas
Philippines	Makati Medical Center	Makati City
Philippines	East Avenue Medical Center	Manila
Philippines	Lung Center of the Philippines	Manila
Philippines	Mary Chiles General Hospital	Manila
Philippines	University of the Philippines - Philippine General Hospital	Manila
Philippines	Far Eastern University-Nicanor Reyes Medical Foundation Medical Center	Quezon City
Philippines	St. Luke's Medical Foundation Medical Center	Quezon City
Russian Federation	Central Clinical Hospital of the Russian Academy of Sciences	Engels
Russian Federation	Oris LLC	Moscow
Russian Federation	Zvezdnaya Clinic	Moscow
Russian Federation	UZI-4D Clinic LLC	Pyatigorsk
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	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Countries where clinical trial is conducted

Indonesia,  Philippines,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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;
Secondary	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;
Secondary	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;
Secondary	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;
Secondary	The mortality caused by COVID-19	To evaluate the mortality caused by COVID-19	More than 14 days (=15 days) after full-course immunization;
Secondary	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;
Secondary	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
Secondary	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