This is a study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses.
This is a phase I, open-label clinical study to evaluate the ability of UB-612 vaccine to boost immunity of subjects who previously received two doses of AstraZeneca COVID-19 vaccine (ChAdOx1-S) with an 8-16 week interval between first and second doses. This study will enroll approximately 30 subjects aged 20 to 55 years. The previous COVID-19 vaccine series will have been completed at least six months before study enrollment. Both sexes should be evenly distributed in subjects. Subjects will be enrolled to receive one dose of 100 μg UB-612 vaccine at Day 1. The subjects will come to the clinics at Visit 1 (screening, Day -28 to -1), Visit 2 (Day 1, vaccination), Visit 3 (Day 15, 14 days after vaccination), Visit 4 (Day 29, 28 days after vaccination), Visit 5 (Day 169, 6 months after vaccination) and will receive phone calls at 7 days after vaccination for safety check.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.
Safety and tolerability
* Local solicited adverse events * Systemic solicited adverse events * Skin allergic reactions
Time frame: within 7 days after vaccination
Safety and tolerability
• Unsolicited adverse events
Time frame: 28 days after vaccination
Immunogenicity
• Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild type
Time frame: 14 days after vaccination
Immunogenicity
• Seroconversion rate (SCR) of neutralizing antibody against SARS-CoV-2 wild type
Time frame: 14 days after vaccination
Immunogenicity
• Geometric mean fold increase (GMFI) of neutralizing antibody against SARS-CoV-2 wild type
Time frame: 14 days after vaccination
Safety
* Adverse events) * AE of special interest * Vaccine-associated enhanced disease * Serious adverse events * Medically attended adverse events
Time frame: Day 1
Safety
* Adverse events) * AE of special interest * Vaccine-associated enhanced disease * Serious adverse events * Medically attended adverse events
Time frame: 14 days after vaccination
Safety
* Adverse events) * AE of special interest * Vaccine-associated enhanced disease * Serious adverse events * Medically attended adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 28 days after vaccination
Safety
* Adverse events) * AE of special interest * Vaccine-associated enhanced disease * Serious adverse events * Medically attended adverse events
Time frame: 6 months after vaccination
Evaluation of safety of hematology and biochemistry
Change of safety laboratory measurement from pre-vaccination
Time frame: Pre-vaccination
Immunogenicity
• GMT of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 14 days after vaccination
Immunogenicity
• SCR of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 14 days after vaccination
Immunogenicity
• GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 14 days after vaccination
Immunogenicity
• GMT of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 28 days after vaccination
Immunogenicity
• SCR of neutralizing antibody against SARS-CoV-2 wild type, antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 28 days after vaccination
Immunogenicity
• GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 28 days after vaccination
Immunogenicity
• GMT of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 6 months after vaccination
Immunogenicity
• SCR of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 6 months after vaccination
Immunogenicity
• GMFI of neutralizing antibody against SARS-CoV-2 wild type, , antigen-specific antibody titers (anti-S1-RBD), S1-RBD:ACE2 binding inhibition antibody
Time frame: 6 months after vaccination
Immunogenicity
• GMT of neutralizing antibody titers against SARS-CoV-2 variant
Time frame: 14 days after vaccination
Immunogenicity
• SCR of neutralizing antibody titers against SARS-CoV-2 variant
Time frame: 14 days after vaccination
Immunogenicity
• GMFI of neutralizing antibody titers against SARS-CoV-2 variant
Time frame: 14 days after vaccination
Immunogenicity
• Reduction fold of GMT compared with neutralizing antibody titers against SARS-CoV-2 wild type
Time frame: 14 days after vaccination
Immunogenicity
• GMT of neutralizing antibody titers against SARS-CoV-2 variant
Time frame: 28 days after vaccination
Immunogenicity
• SCR of neutralizing antibody titers against SARS-CoV-2 variant
Time frame: 28 days after vaccination
Immunogenicity
• GMFI of neutralizing antibody titers against SARS-CoV-2 variant
Time frame: 28 days after vaccination
Immunogenicity
• Reduction fold of GMT compared with neutralizing antibody titers against SARS-CoV-2 wild type
Time frame: 28 days after vaccination
Immunogenicity
• T cell responses
Time frame: Day 1
Immunogenicity
• T cell responses
Time frame: 14 days after vaccination