Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine 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
A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines. 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
A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. This is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of UB-612 COVID-19 vaccine in adults who completed two vaccinations of UB-612 vaccine 10, 30, and 100 μg in V-122 study. 60 subjects will receive one booster dose of UB-612 vaccines 100 μg with the same dose which was offered in Phase II study, at least 6 months after first vaccination. In this study, there will be 3 clinical visits. Subjects will come to the clinics at Day 1
A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities. This Phase 2/3 trial will enroll a total of 7320 male and female subjects randomized in a double-blind manner to receive either UB-612 or placebo. Assignment will be stratified by age (18 to 59 years and ≥60 years) and by presence/absence of comorbidities.All subjects will receive 2 doses of the study vaccine, separated by 28 days, as an intramuscular (IM) injection.Phase 2 and Phase 3 will start simultaneously; Phase 2 will enroll all Strata #1 to #4; Phase 3 will enroll
A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers 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
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults, aged from 20 to 55 years old. This is a phase I, open-label, dose-escalation clinical study to evaluate the safety , tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults. Up to 60 subjects (20 subjects per group) will be enrolled into this study. Subjects in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval (Day 0 and Day 28).
, quarantine of COVID-19 cases, travel and gathering restriction, were implemented. In the meanwhile, two COVID-19 vaccines, namely MVC-COV1901 and UB-612, have been developed under the support of government. Furthermore, MVC-COV1901 was taken into clinical practice after received emergency use approval. In addition, two traditional Chinese medicines, including NRICM101 and NRICM102 showed their promising
A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants. BackgroundThe Delta and Omicron variants of SARS-CoV-2 are currently responsible for breakthrough infections due to waning immunity. We report phase I/II trial results of UB-612, a multitope subunit vaccine containing S1-RBD-sFc protein and rationally designed promiscuous peptides representing sarbecovirus conserved helper T cell and cytotoxic T lymphocyte epitopes on the nucleocapsid (N), membrane (M), and spike (S2) proteins.MethodWe conducted a phase I primary 2-dose (28 days apart) trial of 10, 30, or 100 μg UB-612 in 60 healthy young adults 20 to 55 years old, and 50 of them were boosted with 100 μg of UB-612 approximately 7 to 9 months after the second dose. A separate placebo
A Novel RBD-Protein/Peptide Vaccine Elicits Broadly Neutralizing Antibodies and Protects Mice and Macaques against SARS-CoV-2. The development of safe and effective vaccines to respond to COVID-19 pandemic/endemic remains a priority. We developed a novel subunit protein-peptide COVID-19 vaccine candidate (UB-612) composed of: (i) receptor binding domain of SARS-CoV-2 spike protein fused to a modified single-chain human IgG1 Fc; (ii) five synthetic peptides incorporating conserved helper and cytotoxic T lymphocyte (Th/CTL) epitopes derived from SARS-CoV-2 structural proteins (three from S2 subunit, one from membrane and one from nucleocapsid), and one universal Th peptide; (iii) aluminum phosphate as adjuvant. The immunogenicity and protective immunity induced by UB-612 vaccine were evaluated