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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,005
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) contains purified S protein of SARS-CoV-2 - Dose: 5 µg, aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005%, Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.
Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia
Dr. Soebandi General Hospital
Jember, East Java, Indonesia
RECRUITINGJember Paru Hospital
Jember, East Java, Indonesia
RECRUITINGDr. Saiful Anwar General Hospital
Malang, East Java, Indonesia
The Humoral Immunogenicity Profile
The level of SARS-CoV-2 neutralizing and non neutralizing antibody among participants
Time frame: 28 days after the second vaccination
The Safety Profile
Evaluate number of adverse events occur among participants
Time frame: Within 30 minutes, 24 hours, 7 and 28 days following each dose and 3 and 6 months after the second doses of vaccination
The Humoral Immunogenicity Profile
The level of SARS-CoV-2 neutralizing and non neutralizing antibody among participants
Time frame: 3 and 6 months following the second vaccination
The Cellular Immunogenicity Profile
Evaluate Th1 and Th2 immune responses including CD4+/CD8+. IL-2, IL-4, TNF alpha, IFN gamma, and other markers after stimulation of PBMC with SARS-CoV-2 protein peptides and Interferon gamma release assay (IGRA) to assess the production of IFN-γ from stimulated CD4+ and CD8+ with antigen peptides specific to SARS-CoV-2 among participants
Time frame: 3 and 6 months after the second vaccination
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Airlangga University Hospital
Surabaya, East Java, Indonesia
RECRUITINGDr. Soetomo General Hospital
Surabaya, East Java, Indonesia
RECRUITING