Clinical trial NCT05096845: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19 Pandemic
Keywords: V-01
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 22500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity)
timeFrame: More than 14 days (≥15 days) after full course immunization
measure: The incidence of adverse events (AEs) of V-01
timeFrame: From the first vaccination to 28 days after full-course immunization
Secondary outcomes:
measure: The efficacy of V-01 for the prevention of COVID-19 of severe or above in severity
timeFrame: More than 14 days (≥15 days) after full-course immunization;
measure: The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity)
timeFrame: More than 14 days (≥15 days) after full-course immunization;
measure: The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity) in different age groups
timeFrame: More than 14 days (≥15 days) after full-course immunization;
measure: The morbidity of suspected but not confirmed COVID-19 (negative or not detected)
timeFrame: More than 14 days (≥15 days) after full-course immunization;
measure: The mortality caused by COVID-19
timeFrame: More than 14 days (≥15 days) after full-course immunization;
measure: The hospitalization rate caused by COVID-19
timeFrame: More than 14 days (≥15 days) after full-course immunization;
measure: The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
timeFrame: From the first dose of recombinant SARS-CoV-2 fusion protein vaccine (V-01) to 12 months after full-course immunization
measure: The seroconversion rate of serum SARS-CoV-2 RBD protein-binding antibody, geometric mean titer (GMT) and geometric mean increase (GMI)
timeFrame: At day 28, month 3, month 6, and month 12 after full-course immunization
Other outcomes:
measure: The severity of COVID-19, so as to evaluate the vaccine-mediated antibody-dependent enhancement (ADE)
timeFrame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
measure: The correlation of immunogenicity and efficacy through evaluating the titer level of RBD protein-binding antibody in confirmed COVID-19 cases
timeFrame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
measure: SARS-CoV-2 nucleic acid sequence in symptomatic and RT-PCR-positive COVID-19 cases
timeFrame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
measure: The immunogenicity of V-01 against new SARS-CoV-2 variants
timeFrame: From the first dose of recombinant SARS-CoV-2fusion protein vaccine (V-01) to 12 months after full-course immunization
Locations:
city: Padang
country: Indonesia
facility: Andalas University Hospital
city: Samarinda
country: Indonesia
facility: Medical Faculty of Mulawarman University
city: Sumedang
country: Indonesia
facility: Medical Faculty of Padjadjaran University
city: Tangerang
country: Indonesia
facility: Medical Faculty of UIN Syarif Hidayatullah
city: Lipa city
country: Philippines
facility: Mary Mediatrix Medical Center
state: Batangas
city: Iloilo City
country: Philippines
facility: The Medical City- Iloilo
state: Iloilo
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: University of the Philippines - Philippine General Hospital
city: Manila
country: Philippines
facility: East Avenue Medical Center
city: Manila
country: Philippines
facility: Lung Center of the Philippines
city: Manila
country: Philippines
facility: Mary Chiles General Hospital
city: Quezon City
country: Philippines
facility: Far Eastern University-Nicanor Reyes Medical Foundation Medical Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Foundation Medical Center
city: Engels
country: Russian Federation
facility: Central Clinical Hospital of the Russian Academy of Sciences
city: Moscow
country: Russian Federation
facility: Oris LLC
city: Moscow
country: Russian Federation
facility: Zvezdnaya Clinic
city: Pyatigorsk
country: Russian Federation
facility: UZI-4D Clinic LLC
city: Saint Petersburg
country: Russian Federation
facility: Institute of Medical Research LLC
city: Saint Petersburg
country: Russian Federation
facility: Lab. of molecular virology Smorodintsev Research Institute of Influenza MoH
city: Saint Petersburg
country: Russian Federation
facility: LLC "Uromed"
city: Saint Petersburg
country: Russian Federation
facility: Medical Technologies
city: Saint Petersburg
country: Russian Federation
facility: N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences
city: Saint Petersburg
country: Russian Federation
facility: Research Center ECO Safety LLC
city: Saint Petersburg
country: Russian Federation
facility: State Budgetary Healthcare Institution "Nikolaevskaya hospital"
city: Saint Petersburg
country: Russian Federation
facility: Strategic Medical Systems LLC
Study officials:
References: