A Phase Ⅰ Trial to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine LYB001

Summary

This is a randomized, double-blind, placebo-controlled Phase Ⅰ trial in healthy adults aged 18 years and older, intended to evaluate the safety, reactogenicity, and immunogenicity profile of LYB001. The study vaccine will be administered IM at upper arm deltoid as a three-dose regimen with 28d interval on day 0, 28, 56. To ensure the safety of the participants, the phase Ⅰ trial was will be carried out in a dose-escalation and age-sequential enrolment manner: 1. The safety, reactogenicity, and immunogenicity will be firstly evaluated in a cohort of adults aged 18-59 years randomly assigned (4:1) either to receive low-dose (25µg) LYB001 or placebo. After confirmation of an favorable 7-day safety, reactogenicity profile in this cohort by investigator, the study was able to proceed to the cohort of adults aged 18-59 years receiving high-dose (50µg) LYB001 or placebo. 2. After completing a favorable 7-day safety observation following the first dose of 50μg LYB001 in cohorts aged 18-59 years, the study was able to advance to cohorts aged ≥ 60 years receiving low-dose (25µg) LYB001 or placebo. By analogy, all dose and age-stratified groups will be sequentially enrolled. The study will be ended after all participants completed 360-day safety observation following the 3rd dose of vaccination.

Timeline

Start

2021-12

Primary completion

2023-02

Completion

2023-04

Drugs

Indications