This is a multicenter, international, randomized, active-controlled platform study with each sub-study designed to randomize subjects to receive a single injection with UB-612 or a comparator COVID-19 vaccine in 1:1 ratio.
The current platform protocol is designed to determine the safety and immunizing activity of a booster dose of 100 μg UB-612 in patients who have received a different vaccine 3 months or more before the study start (i.e., Day 1). The randomized, active-controlled multicenter study sponsored by Vaxxinity will be conducted in several countries under a master platform protocol outlining common objectives, endpoints, population, study design, and data analysis. The platform protocol is designed for multiple sub-studies to be implemented at any time, each independently addressing the same set of scientific questions aimed to evaluate the immune responses after a booster injection with UB-612 vaccine candidate and a particular comparator COVID-19 vaccine product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
944
UB-612 (100µg), 0.5mL suspension, intramuscular injection
BNT162b2 vaccine (30µg), 0.3mL suspension, intramuscular injection
ChAdOx1-S vaccine, 0.5 mL suspension with approximately 5.0 × 10˄10 viral particles, intramuscular injection
PanAmerican Clinical Research
Brownsville, Texas, United States
Cevaxin David
David, Panama
Cevaxin 24 de Dieciembre
Panama City, Panama
Cevaxin The Panama Clinic
Panama City, Panama
Presence of solicited local or systemic reactions
Local: pain, tenderness, erythema, induration, pruritis. Systemic: Nausea, diarrhea, headache, fatigue, myalgia, chills, joint pain, rash
Time frame: Day 8 after injection
Presence of unsolicited local or systemic reactions
Any AE reported by the subject that is not specified as a solicited
Time frame: Day 29 after injection
Presence of serious adverse events
SAE are reported through the study
Time frame: Day 387 after injection
Presence of medically attended adverse events
AE that leads to an unscheduled visit
Time frame: Day 387 after injection
Presence of adverse events of special interest
AESI are reported throughout the study
Time frame: Day 387 after injection
Boost in neutralizing antibody titers against Wuhan strain at Day 29
Geometric Mean Titer Ratios of neutralizing antibodies at Day 29 determined using replicating or pseudotyped virus
Time frame: Day 29 after injection
Boost in neutralizing antibody titers against Omicron strain at Day 29
Geometric Mean Titer Ratios of neutralizing antibodies at Day 29 determined using replicating or pseudotyped virus
Time frame: Day 29 after injection
Responders determined on Day 29 (Wuhan)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sinopharm BIBP COVID-19 vaccine, 0.5mL (4µg) suspension, intramuscular injection
Health Index Multispecialty
Bacoor, Philippines
Iloilo Doctors Hospital
Iloilo City, Philippines
St Pauls Hospital Iloilo City
Iloilo City, Philippines
Proportion of subjects with ≥4-fold antibody titer rise from Day 1 to Day 29
Time frame: Day 1 to 29 after injection
Responders determined on Day 29 (Omicron)
Proportion of subjects with ≥4-fold antibody titer rise from Day 1 to Day 29
Time frame: Day 1 to 29 after injection
Kinetics and duration of antibody response - Responders via neutralizing antibodies
Proportion of subjects with ≥4-fold antibody titer rise over the life of trial measured by neutralizing antibodies determined using replicating or pseudotyped virus
Time frame: Day 1 to Day 15, Day 29, and Months 6 and 12
Kinetics and duration of antibody response - Responders via binding to S1-RBD
Proportion of subjects with ≥4-fold antibody titer rise over the life of trial measured by IgG antibodies titers measured by direct S1-RBD binding ELISA
Time frame: Day 1 to Day 15, Day 29, and Months 6 and 12
Kinetics and duration of antibody response - GMFI via neutralizing antibodies
Geometric Mean Fold Increase of neutralizing antibodies determined using replicating or pseudotyped virus
Time frame: Day 1 to Day 15, Day 29, and Months 6 and 12
Kinetics and duration of antibody response - GMFI via binding to S1-RBD
Geometric Mean Fold Increase of IgG antibodies titers measured by direct S1-RBD binding ELISA
Time frame: Day 1 to Day 15, Day 29, and Months 6 and 12
Kinetics and duration of antibody response - AUC via neutralizing antibodies
Area under the curve (AUC) by treatment group and virus variants calculated from neutralizing antibody response determined using replicating or pseudotyped virus
Time frame: Day 15 to Month 12
Kinetics and duration of antibody response - AUC via binding to S1-RBD
Area under the curve (AUC) by treatment group and virus variants calculated from IgG antibody response measured by direct S1-RBD binding ELISA
Time frame: Day 15 to Month 12
Kinetics and duration of antibody response - GMT via neutralizing antibodies
Geometric Mean Titers measured by neutralizing antibody response by treatment group and virus variants
Time frame: Days 15, 29, and Months 6 and 12
Kinetics and duration of antibody response - GMT via binding to S1-RBD
Geometric Mean Titers measured by IgG antibody response measured by direct S1-RBD binding ELISA
Time frame: Days 15, 29, and Months 6 and 12
Kinetics and duration of antibody response - Reverse Cumulative Distribution Curve via neutralizing antibodies
Distribution of neutralizing antibody titers displayed as reverse cumulative distribution curves by treatment group and virus variants measured by neutralizing antibody response
Time frame: Day 29 and Month 6 and 12
Kinetics and duration of antibody response - Reverse Cumulative Distribution Curve via binding to S1-RBD
Distribution of IgG antibody titers displayed as reverse cumulative distribution curves by the treatment group and virus variant measured IgG antibody response measured by direct S1-RBD binding ELISA
Time frame: Day 29 and Month 6 and 12