NCT05293665

Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine

A Phase 3 Multi-Center International, Randomized, Active-Controlled Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 944 (actual)
• Sponsor: Vaxxinity, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19 Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	UB-612	UB-612 (100µg), 0.5mL suspension, intramuscular injection
BIOLOGICAL	BNT162b2 vaccine	BNT162b2 vaccine (30µg), 0.3mL suspension, intramuscular injection
BIOLOGICAL	ChAdOx1-S vaccine	ChAdOx1-S vaccine, 0.5 mL suspension with approximately 5.0 × 10˄10 viral particles, intramuscular injection
BIOLOGICAL	Sinopharm BIBP	Sinopharm BIBP COVID-19 vaccine, 0.5mL (4µg) suspension, intramuscular injection

Timeline

• Start date: 2022-03-16
• Primary completion: 2022-11-01
• Completion: 2023-09-01
• First posted: 2022-03-24
• Last updated: 2022-10-14

Locations

7 sites across 3 countries: United States, Panama, Philippines

Regulatory

• FDA-regulated drug study