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

NCT05293665 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 944

Last updated 2022-10-14

No results posted yet for this study

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.

Conditions

  • COVID-19 Vaccines

Interventions

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

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Vaxxinity, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2022-11-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States
  • Panama
  • Philippines

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05293665 on ClinicalTrials.gov