A Multicenter, Randomized, Double Blind, Controlled, Phase III Clinical Trial (Immunobridging Study) of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in Healthy Population Aged 18 Years and Above
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19 Pandemic
- Sponsor
- Dr. Soetomo General Hospital
- Enrollment
- 4005
- Locations
- 5
- Primary Endpoint
- The Humoral Immunogenicity Profile
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a multicenter, randomized, double blind, controlled, phase III clinical trial (Immunobridging Study) to evaluate the immunogenicity and safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in healthy populations aged 18 years and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in human.
Detailed Description
This is a double blind randomized controlled trial - immunobridging study. There will be 2 groups in the study. One adult group (18 year-old and above) with 5 µg dose, and 1 control group using CoronaVac Bio Farma. Both vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 6 months. This study will have two interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the blinded 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 6 months after the second dose
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
- •Subjects have been informed properly regarding the study and signed the informed consent form.
- •Subject will commit to comply with the instructions of the investigator and the schedule of the trial
- •Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
- •Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
Exclusion Criteria
- •Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial.
- •Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
- •Known history of allergy to any component of the vaccines.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Any autoimmune or immunodeficiency disease/condition
- •Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted.
- •Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
- •Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
- •Individuals who previously receive any vaccines against Covid-
- •Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
Outcomes
Primary Outcomes
The Humoral Immunogenicity Profile
Time Frame: 28 days after the second vaccination
The level of SARS-CoV-2 neutralizing and non neutralizing antibody among participants
Secondary Outcomes
- The Humoral Immunogenicity Profile(3 and 6 months following the second vaccination)
- The Safety Profile(Within 30 minutes, 24 hours, 7 and 28 days following each dose and 3 and 6 months after the second doses of vaccination)
- The Cellular Immunogenicity Profile(3 and 6 months after the second vaccination)