severe acute respiratory syndrome coronavirus 2 SARS CoV 2
Conditions
Interventions
Placebo
Recombinant SARSCoV2 fusion protein vaccine V01
Sponsors
Livzon Mabpharm Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Voluntarily participate in this study and sign the informed consent form Adults aged 18 years and older, male or female 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 are able to and willing to follow the requirements of the protocol 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 negative pregnancy test at screening and at the day of vaccination
Exclusion criteria
Exclusion criteria: History of previous COVID19 infection Positive result for RTPCR test in screening period, or specific antibody IgG or IgM meet the following conditions If both IgG and IgM are negative the participant can be vaccinated without waiting for the RTPCR test results 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 eg acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain etc or be allergic to any components of V01 Any confirmed or suspected immunosuppression or immunodeficiency condition known from medical history, including human immunodeficiency virus infection asplenia Serious or uncontrolled cardiovascular diseases, nervous system disorders eg 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 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 medications to prevent COVID19 e g use of antipyretics without pyrexia and any other symptoms History of vaccination against SARSCoV2 marketed or investigational 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 Injection of immunoglobulin and/or other blood products within 3 months before the administration of inves
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives Efficacy: 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) Safety: 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; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: Efficacy: 1. 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; ? Definition of COVID-19 of severe or above severity (meeting any one of the following): 1) Tachypnea, respiratory rate = 30 breaths/min; 2) Oxygen saturation [SpO2]=93% at rest; 3) Arterial partial pressure of oxygen/fraction of inspired oxygen [PaO2/FiO2]=300mmHg (in the areas with altitude over 1000 meters, PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2×[760/atmospheric pressure (mmHg)]); 4) Progressive worsening of clinical symptoms; chest imaging showing significant lesion progression > 50% within 24 to 48 hours (if any); 5) Respiratory failure and requiring mechanical ventilation; 6) Shock; 7) With other organ failure that requires intensive care unit (ICU) care. 2. 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 the first vaccination; 3. 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 in different age groups; 4. To evaluate the morbidity of suspected but not confirmed COVID-19 (negative or not detected); 5. To evaluate the mortality caused by COVID-19; 6. To evaluate the hospitalization rate caused by COVID-19; Safety: 1. 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; | — |
Countries
Ghana, Rwanda, Uganda
Contacts
Public ContactVincent Mutabazi
Principal investigator
Outcome results
None listed