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

NCT05125926 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-11-18

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

LYB001

The investigational vaccine, with its antigen consisting of receptor-binding domain (RBD) from SARS-CoV-2 and virus-like particle (VLP) vector, adjuvanted with aluminum hydroxide. The investigational are administered through Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56.

BIOLOGICAL

Placebo

Aluminum hydroxide

Sponsors & Collaborators

  • Yantai Patronus Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2023-02-28
Completion
2023-04-30

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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 NCT05125926 on ClinicalTrials.gov