Phase Ⅱ and Ⅲ Trial of a SARS-CoV-2 Vaccine LYB001

COVID-19 Clinical Trial

Official title: Immunogenicity and Safety of a SARS-CoV-2 Vaccine LYB001 in Healthy Adults: a Randomized, Double Blinded, Placebo-controlled Phase Ⅱ Trial and a Single-arm, Open-label Phase Ⅲ Trial for Extended Safety

Status Not yet recruiting

Clinical Trial Summary

The phase Ⅱ trial adopts a randomized, double-blind, placebo-controlled design to evaluate the immunogenicity and safety profile of LYB001 in healthy adults aged 18 years and older. This Phase III study adopts a single-arm, open-label design to evaluate the expanded safety of LYB001 in healthy subjects 18 years of age and older. The study vaccine will be administered IM at upper arm deltoid as a three-dose regimen with 28d interval on day 0, 28, 56.

The phase Ⅱ trial will be carried out in an age-sequential enrolment manner:

1. A DSMB meeting will be held after the completion of the 7-day safety observation following each vaccination of high-dose LYB001 or placebo in participants aged 18-59 years in phase Ⅰ trial. Thereafter, the DSMB will recommend whether to initiate enrollment of younger adult participants in the Phase II trial based on the findings, who will receive low dose (25μg), high dose (50μg) LYB001 or placebo at a ratio of 3:3:1.

2. A DSMB meeting will be held after the completion of the 7-day safety observation following each vaccination of high-dose LYB001 or placebo in participants aged ≥60 year in phase Ⅰ trial. Thereafter, the DSMB will recommend whether to initiate enrollment of older adult participants in the Phase II trial based on the findings, who will receive low dose (25μg), high dose (50μg) LYB001 or placebo at a ratio of 3:3:1.

3. The phase Ⅱ trial will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.

Phase III trial (the expanded safety study):

1. After completion of the 7-day safety observation following the first immunization of all cohorts in the Phase II trial, a DSMB meeting will be held to recommend whether to initiate enrollment of participants in the Phase III trial. A total of 1200 subjects will be enrolled in younger adult and older adults, with older adults accounting for ≥20% of the population, and appropriate doses will be determined based on the results of early clinical trials.

2. The phase III trial will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05137444
• Study type: Interventional
• Source: Yantai Patronus Biotech Co., Ltd.
• Contact: Jingwen Qu
• Phone: +8615626903973
• Email: qujingwen@luye.com
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2022
• Completion date: May 2023