NCT04773067

A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers

Terminated Phase 2 Last updated 26 August 2022

What this trial tests

Phase 2 trial testing UB-612 in COVID-19 in 3,877 participants. Terminated before completion.

Timeline

30 January 2021

Primary endpoint
8 March 2022

8 March 2022

Quick facts

Lead sponsor	United Biomedical Inc., Asia
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	3,877
Start date	30 January 2021
Primary completion	8 March 2022
Estimated completion	8 March 2022
Sites	12 locations across Taiwan

Drugs / interventions tested

• UB-612 — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

United Biomedical Inc., Asia — full company profile →

Who can join

Adults 12 to 85, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
2. Scientific rationale for developing potent RBD-based vaccines targeting COVID-19.
   Kleanthous H, Silverman JM, Makar KW, Yoon IK, et al · · 2021 · cited 118× · PMID 34711846 · DOI 10.1038/s41541-021-00393-6
3. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
   Luxi N, Giovanazzi A, Capuano A, Crisafulli S, et al · · 2021 · cited 98× · PMID 34739716 · DOI 10.1007/s40264-021-01131-6
4. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
   Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
5. A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants.
   Wang CY, Hwang KP, Kuo HK, Peng WJ, et al · · 2022 · cited 66× · PMID 35316221 · DOI 10.1172/jci157707
6. Safety and efficacy of COVID-19 vaccines in children and adolescents: A systematic review of randomized controlled trials.
   Tian F, Yang R, Chen Z. · · 2022 · cited 47× · PMID 35705969 · DOI 10.1002/jmv.27940
7. Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses.
   Wang CY, Peng WJ, Kuo BS, Ho YH, et al · · 2023 · cited 30× · PMID 37079651 · DOI 10.1371/journal.ppat.1010870
8. High Neutralizing Antibody Levels Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1 and BA.2 After UB-612 Vaccine Booster.
   Guirakhoo F, Wang S, Wang CY, Kuo HK, et al · · 2022 · cited 18× · PMID 35723969 · DOI 10.1093/infdis/jiac241