This is a phase II, observer-blind, multiple-centre, randomized, placebo-controlled study to evaluate the immunogenicity, safety, tolerability and lot consistency of 2 doses of UB-612 vaccine in adolescent, younger and elderly adults. Around 3850 adult subjects will be randomized to be composed of the core group, while around 385 adolescents will be randomized to be the supplementary group. Subjects will be unblinded at Visit 5, and subjects in the vaccine group will be encouraged to have 3rd dose of vaccination.
This clinical study will be consisted of 7 clinical visits and one long-term follow-up visit. Subjects will also be unblinded at Visit 5, subjects in placebo group will withdraw from the study and subjects in vaccine group will be encouraged to have 3rd dose of vaccination (Day 197\~Day 242) at Visit 6. Those who received 3rd dose will have Visit 7 (14 days after Visit 6) to check the booster effect. After Day 197, subjects will enter the long-term follow-up with a safety call bi-monthly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,877
Changhua Christian Hospital
Changhua, Taiwan
Chang-Geng Medical Foundation Kaoshiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody
Immunogenicity evaluation
Time frame: Day 57
Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody
Immunogenicity evaluation
Time frame: Day 57
Local reactions and systemic events
Safety evaluation
Time frame: Up to 7 days following each dose
Unsolicited adverse events
Safety evaluation
Time frame: Day 1 to Day 57
Medically attend adverse events (MAAEs), serious adverse events (SAEs), adverse event of special interests (AESIs) and antibody dependent enhancements (ADEs)
Safety evaluation
Time frame: Day 1 to Day 365
SCR of anti-S1-RBD antibody
Immunogenicity evaluation
Time frame: Day 57
GMT of SARS-CoV-2 neutralizing antibody
Immunogenicity evaluation
Time frame: Day 197 and 365
GMT of anti-S1-RBD antibody
Immunogenicity evaluation
Time frame: Day 57, 197 and 365
Geometric mean fold increase in SARS-CoV-2 neutralizing antibody and antigen-specific antibody (Anti-S1-RBD)
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Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
...and 2 more locations
Immunogenicity evaluation
Time frame: Day 57, 197 and 365
Lot consistency by comparisons of GMT of SARS-CoV-2 neutralizing antibody
Evaluation of lot to lot consistency
Time frame: Day 57