A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
Hangzhou Tigermed Consulting Co., Ltd, PT. Equilab International
No Registry
INA-HB8C9XD
Tanggal Input Registry : 24-04-2024

31-07-2021
Efficacy of recombinant COVID-19 vaccine (Sf9 cell) in preventing virologically confirmed (PCR positive) symptomatic COVID-19
NA
 
A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older
A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older.
Interventional
Recombinant COVID-19 vaccine (Sf9 cell)
8000
 

Inclusion Criteria:

Aged 18 years and older, Able and willing (in the investigator’s opinion) to comply with all study requirements,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, 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, For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 90 days after completion of 3 doses vaccination, and have negative pregnancy tests before each dose vaccination, 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, Agreement to refrain from blood donation during the study, Provide written informed consent form

Exclusion Criteria:

Participation in any other COVID-19 prophylactic drug trials during the duration of the study, Positive HIV antibody testing results, Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus during the duration of the study, Planned receipt of any licensed or investigational vaccine, other than the study intervention, within 14 days before and after study vaccination, Prior receipt of an investigational or licensed COVID-19 vaccine, Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the investigational products (IPs), 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, History of allergic disease or reactions likely to be exacerbated by any component of Recombinant COVID-19 vaccine (Sf9 cell), Any history of angioedema, Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine, Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ), History of serious psychiatric condition likely to affect participation in the study, Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture, Suspected or known current alcohol or drug dependency, 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), History of laboratory-confirmed COVID-19, Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban), 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.
 
54/KEPK-RSUPP/ 05 /2021
Not applicable
PPUK/PPUB number
JSVCT109
dr. Sita Andarini, Sp.P(K), Ph.D