A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III ClinicalStudy to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older
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).
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 Name: V-01
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.
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.
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, Indonesia
Mary Mediatrix Medical Center
Lipa city, Batangas, Philippines
The Medical City- Iloilo
Iloilo City, Iloilo, Philippines
Makati Medical Center
Makati City, Philippines
University of the Philippines - Philippine General Hospital
Manila, Philippines
East Avenue Medical Center
Manila, Philippines
Lung Center of the Philippines
Manila, Philippines
Mary Chiles 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, Philippines
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, Russian Federation
Not Provided