UB-612 / Aurobindo, Vaxxinity - LARVOL DELTA

Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial. (PubMed, EClinicalMedicine) - P3 | "This Phase 3, multicenter, international, randomized, active-controlled trial compared UB-612 as a third-dose heterologous booster to BNT162b2, ChAdOx1-S, or BBIBP-CorV homologous boosters in healthy subjects aged ≥16 years. In a pivotal Phase 3 study, UB-612 demonstrated the potential for broad use as a cross-platform heterologous booster, restoring protective immunity in adults previously vaccinated with mRNA, adenovirus-vectored, or inactivated virus-based COVID-19 vaccines. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and Vaxxinity."

Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Bridging the Gaps: The Urgency for a Pan-SARS-CoV-2 Vaccine and the Potential of T Cell Immunity-promoting UB-612 Vaccine that targets both Spike and non-Spike proteins (IVC-MG 2024) - "By targeting Spike and non-Spike proteins, UB-612 vaccine-induced immunity could mirror that of natural infection. In contrast with the currently authorized vaccines relying solely on the Spike protein, a hybrid immunity involving natural infection plus UB-612 vaccination may potentially provide safe, robust, and long-lasting protection against reinfection of any severity."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

RBD-Protein/Peptide Vaccine UB-612 Elicits Mucosal and Fc-Mediated Antibody Responses against SARS-CoV-2 in Cynomolgus Macaques. (PubMed, Vaccines (Basel)) - "The level of mucosal or serum ADMP and ADNKA antibodies was found to be UB-612 dose-dependent. Our results highlight that the novel subunit UB-612 vaccine is a potent B-cell immunogen inducing polyfunctional antibody responses contributing to anti-viral immunity and vaccine efficacy."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

UB-612: A novel peptide/protein subunit COVID-19 vaccine booster stimulated broadly neutralizing and Fc-mediated effector antibodies in a head-to-head Phase 3 randomized clinical trial (VACCINES SUMMIT 2023) - "• UB-612 was generally safe and well tolerated throughout the trial. • UB-612 is under review for conditional/provisional market authorization as a COVID-19 booster with stringent health agencies in the UK and Australia."

Clinical • Head-to-Head • P3 data • Infectious Disease • Novel Coronavirus Disease

A Novel RBD-Protein/Peptide Vaccine Elicits Broadly Neutralizing Antibodies and Protects Mice and Macaques against SARS-CoV-2. (PubMed, Emerg Microbes Infect) - P3 | "The vaccination significantly reduced viral loads, lung pathology scores, and disease progression after intranasal and intratracheal challenge with SARS-CoV-2 in mice, rhesus and cynomolgus macaques. UB-612 has been tested in primary regimens in Phase 1 and Phase 2 clinical studies and is currently being evaluated in a global pivotal Phase 3 clinical study as a single dose heterologous booster.Trial registration: ClinicalTrials.gov identifier: NCT05293665.."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine (clinicaltrials.gov) - P3 | N=944 | Active, not recruiting | Sponsor: Vaxxinity, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease

High neutralizing antibody levels against SARS-CoV-2 Omicron BA.1 and BA.2 after UB-612 vaccine booster. (PubMed, J Infect Dis) - "Based on the RBD protein-binding antibody responses, the UB-612 third dose booster may lead to an estimated ∼95% efficacy against symptomatic COVID-19 caused by the ancestral strain. Our results support UB-612 as a potential potent booster against current and emerging SARS-CoV-2 variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers (clinicaltrials.gov) - P2 | N=3877 | Terminated | Sponsor: United Biomedical Inc., Asia | Active, not recruiting ➔ Terminated; Under the limited resources, to re-plan the ongoing clinical trials of this product.

Trial termination • Infectious Disease • Novel Coronavirus Disease

[PREPRINT] High neutralizing antibody levels against SARS-CoV-2 Omicron BA.1 and BA.2 after UB-612 vaccine booster (bioRxiv) - P=N/A | N= N/A | “Here, we demonstrate that a booster dose of UB-612 vaccine candidate delivered 7-9 months after primary vaccination increases neutralizing antibody levels by 131-, 61- and 49-fold against ancestral SARS-CoV-2, Omicron BA.1 and BA.2 variants, respectively. Based on the RBD protein binding antibody responses, we estimated a ∼95% efficacy against symptomatic COVID-19 caused by the ancestral strain after a UB-612 booster. Our results support UB-612 vaccine as a potent booster against current and emerging SARS-CoV-2 variants.”

Clinical • Preprint • Novel Coronavirus Disease

A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Vaxxinity, Inc. | N=7320 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine (clinicaltrials.gov) - P3 | N=1010 | Recruiting | Sponsor: Vaxxinity, Inc.

New P3 trial • Infectious Disease • Novel Coronavirus Disease

A multitope SARS-COV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants. (PubMed, J Clin Invest) - P1, P2 | "UB-612 has presented a favorable safety profile, potent booster effect against VoCs, and long-lasting B- and broad T-cell immunity that warrants further development for both primary immunization and heterologous boosting of other COVID-19 vaccines."

Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers (clinicaltrials.gov) - P2 | N=3877 | Active, not recruiting | Sponsor: United Biomedical Inc., Asia | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2021 ➔ Apr 2022

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines. (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: United Biomedical Inc., Asia | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Ability of UB-612 COVID-19 Vaccine to Boost Immunity of Heterologous COVID-19 Vaccines. (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: United Biomedical Inc., Asia

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine (clinicaltrials.gov) - P1; N=50; Completed; Sponsor: United Biomedical Inc., Asia; Recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Development of Next Generation UB-612 Vaccine (VACCINES SUMMIT 2021) - No abstract available

A Extension Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: United Biomedical Inc., Asia

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: United Biomedical Inc., Asia; Active, not recruiting ➔ Completed; Trial completion date: Aug 2021 ➔ May 2021

Clinical • Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers (clinicaltrials.gov) - P2; N=3850; Recruiting; Sponsor: United Biomedical Inc., Asia; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine (clinicaltrials.gov) - P1; N=60; Active, not recruiting; Sponsor: United Biomedical Inc., Asia; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers (clinicaltrials.gov) - P2; N=3850; Active, not recruiting; Sponsor: United Biomedical Inc., Asia; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] UB-612, a Novel Multitope Protein/Peptide-Based Vaccine against SARS-CoV-2 (PEGS 2021) - "UB-612 consists of eight components rationally designed for induction of high neutralizing antibodies and broad T cell responses against SARS-CoV-2: In preclinical models the vaccine induced high titers of neutralizing and a Th1 oriented T cell response and was protective in challenge studies. Phase 1 trial is being completed and phase 2/3 global efficacy trials will start in Q1 2021."

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers (clinicaltrials.gov) - P2; N=3850; Recruiting; Sponsor: United Biomedical Inc., Asia

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease

COVAXX’s COVID-19 Vaccine, UB-612, Induced Neutralizing Antibodies in 100% of Participants During Phase 1 Clinical Trial (Businesswire) - P1, N=60; NCT04545749; Sponsor: United Biomedical Inc., Asia; "COVAXX...announced positive interim Phase 1 data from its open-label COVID-19 clinical trial conducted in Taiwan....UB-612 was well-tolerated and had a reassuring safety profile....UB-612 induced neutralizing antibodies in 100% of participants....At the 100 ug dose level, anti-S1-RBD and viral neutralizing antibody responses compared favorably to responses observed in hospitalized patients who had recovered from COVID-19."

P1 data • Infectious Disease • Novel Coronavirus Disease