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

Yantai Patronus Biotech Co., Ltd.0 sites1,900 target enrollmentJanuary 2022

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Yantai Patronus Biotech Co., Ltd.
Enrollment: 1900
Primary Endpoint: Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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:

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.
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.
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):

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

Registry

clinicaltrials.gov

Start Date

January 2022

End Date

May 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yantai Patronus Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects aged 18 years and older;
•Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, are capable of providing valid identification, understanding and complying with the requirements of the clinical protocol.
•For female participants of childbearing potential, effective contraception measures should be used within 2 weeks prior to participation in this study and the results of pregnancy test is required to be negative. Participants should voluntarily agree to use effective contraceptive measures from the time of signing the informed consent form to the end of the study (effective contraceptive measures including oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release topical contraceptives, hormonal patches, intrauterine device, sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.).

Exclusion Criteria

•Abnormal results of laboratory screening tests which was clinically significant judged by clinicians;
•Abnormal vital signs with clinical significance at screening, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C;
•Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
•History of human coronavirus infection/diseases, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);
•History of COVID-19, or history of close contact with confirmed/suspected COVID-19 patients, or positive results for either SARS-CoV-2 nucleic acid or antibody tests (IgG and IgM) at screening;
•Administration of antipyretics or painkillers within 24 hours prior to vaccination;
•Receipt of any COVID-19 vaccine, live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactived vaccine within 14 days prior to vaccination;
•Receipt of blood or blood-related products, including immunoglobulins, within 3 months prior to vaccination; or any planned use during the study period.
•Subjects with the following diseases:
•Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；

Outcomes

Primary Outcomes

Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

Time Frame: Change from Baseline at 28 days post dose 3

Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)

SRAS-CoV-2 S protein-binding antibodies

Time Frame: Change from Baseline at 28 days post dose 3

SRAS-CoV-2 S protein-binding antibodies

Adverse events (AEs)

Time Frame: 28 days after each dose

Immediate adverse events (AEs) within 30 minutes after each vaccination, solicited local and systemic AEs for within 7 days and unsolicited AEs within 28 days following each vaccination

Secondary Outcomes

Serious adverse events (SAEs)(360 days after first dose)
SRAS-CoV-2 S protein-binding antibodies(12 months post dose 3)
Neutralizing antibody against SARS-CoV-2 wild type and variants of concern (VOCs)(12 months post dose 3)