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A Phase I/II Study of GLB-COV2-043 as a COVID-19 Vaccine Booster

NCT05602961 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-08-14

No results posted yet for this study

Summary

The scope of this Phase I/II study is to determine whether GLB-COV2-043 is a promising booster vaccine candidate component for adult participants who have received the 2-dose priming course of the mRNA BNT162b2 vaccine against COVID-19, or the 2-dose priming course and a third BNT162b2 injection (i.e., as a "booster"), and, if so, to select the booster dose for further evaluation and potential development.

Conditions

Interventions

DRUG

GLB-COV2-043

COVID-19 vaccine, administered as a booster

DRUG

BNT162b2/COMIRNATY®

active control

Sponsors & Collaborators

  • GreenLight Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Shelly Karuna, MD, MPH · GreenLight Biosciences

  • Etienne Karita, MD, MSc, MSPH · Center for Family Health Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-21
Primary Completion
2024-09-30
Completion
2024-09-30

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Entities

Diseases

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 NCT05602961 on ClinicalTrials.gov