NCT04683224

A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine

A Phase 2/3 Randomized, Multicenter, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 Vaccine in Adults

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Vaxxinity, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2/3, randomized, multicenter, double-blind, dose-response study to evaluate the safety, immunogenicity, and efficacy of UB 612 in 2 age groups, adults 18 to 59 and ≥60 years of age with or without comorbidities.

Detailed description

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 Stratum #1 until the Data and Safety Monitoring Board (DSMB) has reviewed Phase 2 data through Day 43 and endorsed enrolment of Strata #2 to #4. All subjects in Phase 2 and Phase 3 will be followed for safety and efficacy. This Phase 2/3 study also contains a Safety and Immunogenicity Cohort (N=1300) consisting of 1000 SARS-CoV-2 seronegative subjects (320 subjects enrolled in Phase 2 and 680 subjects enrolled in Phase 3) and 300 SARS-CoV-2 seropositive subjects enrolled in Phase 3.

Conditions

• Covid-19
• SARS-CoV-2
• Coronavirus

Interventions

Type	Name	Description
BIOLOGICAL	UB-612	100 µg \[microgram\] of an experimental study vaccine
OTHER	Placebo	Placebo is a 0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2021-02-01
• Primary completion: 2023-03-22
• Completion: 2023-03-22
• First posted: 2020-12-24
• Last updated: 2022-04-04