A global Phase III clinical trial of recombinant COVID-19 vaccine (Sf9 cells) in adults aged 18 years and older
- Conditions
- Coronavirus disease COVID-19
- Registration Number
- PACTR202103845381761
- Lead Sponsor
- Chengdu WestVac Biopharm Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40000
1.Aged 18 years and older.
2.Able and willing (in the investigator’s opinion) to comply with all study requirements.
3.Willing to allow the investigators to discuss the volunteer’s 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).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of recombinant COVID-19 vaccine (Sf9 cells) in preventing virologically confirmed (PCR positive) symptomatic COVID-19;Safety of recombinant COVID-19 vaccine (Sf9 cells) in terms of SAE, MAAE and AESI in all participants from Day 0 through 6 months after completion of 3 doses vaccination
- Secondary Outcome Measures
Name Time Method Efficacy of recombinant COVID-19 vaccine (Sf9 cells) in preventing virologically confirmed (PCR positive) symptomatic COVID-19 cases first occurring ?14 days after completion of 3 doses vaccination, regardless of severity.<br><br>