Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group1:Participants of Efficacy Safety Cohort will receive 3-dose injection on Day 0, Day 21and Day 42
Experimental group2:Participants of Efficacy-Extended Safety-Immunogenicity Cohort will receive 3-dose injection on Day 0, Day 21and Day 42
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and older; 2. Able and willing (in the investigators opinion) to comply with all study requirements; 3. Willing to allow the investigators to discuss the volunteers medical history with their general practitioner/personal doctor and access all medical records which are relevant to study procedures; 4. Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment; 5. For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination during the study, and have a negative pregnancy tests before each dose vaccination; Note: nonchildbearing 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). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status; 6. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination. 7. Agreement to refrain from blood donation during the study; 8. Provide written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. Participation in any other COVID-19 prophylactic drug trials during the duration of the study; Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-19. The study team should be informed as soon as possible; 2. Positive HIV antibody testing results; 3. Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study; Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys; 4. Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination; 5. Prior receipt of an investigational or licensed COVID-19 vaccine; 6. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs); 7. Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV status; asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting <= 14 days) oral steroids are not an exclusion criteria; 8. History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 vaccine (Sf9 cells); 9. Any history of angioedema; 10. Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine; 11. Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ); 12. History of serious psychiatric condition likely to affect participation in the study; 13. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture; 14. Suspected or known current alcohol or drug dependency; 15.Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed) 16. History of laboratory-confirmed COVID-19; 17. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban); 18. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data. Exclusion Criteria for the second/third dose: In this trial, the second/third dose vaccination may be terminated in some cases. These include systemic allergic reactions, severe hypersensitivity reactions, or intolerable grade 3 or higher adverse reactions after the previous vaccination/placebo. If these reactions occur, the participants should not continue to receive the second/third vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ?28 days after completion of 3 doses vaccination, regardless of severity;Serious adverse events from Day 0 through 6 months after completion of 3 doses vaccination;Adverse events of particular concern from Day 0 through 6 months after completion of 3 doses vaccination;Solicited adverse events within 7 days after each dose vaccination;Unsolicited adverse events within 21 days after the first dose and the second dose, and within 28 days after the third dose vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virologically confirmed (PCR positive)symptomatic COVID-19 cases first occurring ?14 days after completion of 3 doses vaccination, regardless of severity;Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring >14 days after completion of 3 doses vaccination;Severe COVID-19 and death (based on WHO criteria) caused by SARS-CoV-2 infection first occurring > 28 days after completion of 3 doses vaccination;Virologically confirmed (PCR positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring > 14 days after completion of 3 doses vaccination;Virologically confirmed (PCR positive) hospitalised moderate, severe COVID-19 and death caused by SARS-CoV-2 infection first occurring > 28 days after completion of 3 doses vaccination;Serologically confirmed SARS-CoV-2 infection or virologically confirmed (PCR positive) COVID-19 cases first occurring >14 days after completion of 3 doses vaccination, regardless of symptomatology or severity;Serologically confirmed SARS-CoV-2 infection or virologically confirmed (PCR positive) COVID-19 cases first occurring > 28 days after completion of 3 doses vaccination, regardless of symptomatology or severity;Serious adverse events, MAAEs and Adverse events of particular concernfrom Day 0 through 12 months after completion of 3 doses vaccination in all participants;The seroconversion rate, GMT and GMI of S-RBD IgG antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination, measured by ELISA;The seroconversion rate, GMT and GMI of live-virus neutralizing antibody on day 28, month 3, month 6 and month 12 after completion of 3 doses vaccination; | — |
Countries
Malaysia
Contacts
Public ContactWei Yuquan
WestVac Biopharma Co., Ltd. and West China Hospital of Sichuan University
Outcome results
None listed