NCT05125926

Brief 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. 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Dec 2021

Typical duration for phase_1 covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

1.2 years

First QC Date

November 12, 2021

Last Update Submit

November 14, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    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;1. 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;

    28 days after each dose

Secondary Outcomes (6)

  • Serious adverse events (SAEs)

    360 days after first vaccination

  • Safety laboratory measures

    3 days after each dose

  • Geometric neutralizing titers (GMT), Geometric Mean Increases (GMI) and seroconversion rates against wild-type SARS-CoV-2

    pre dose 1, day 14 post dose 2, day 14, 28 post dose 3

  • GMT, GMI and seroconversion rates against SARS-CoV-2 variants of concern (VOCs)

    pre dose 1, day 14 post dose 2, day 14, 28 post dose 3

  • GMT, GMI and seroconversion rates of S protein-binding antibodies

    pre dose 1, day 14 post dose 2, day 14, 28 post dose 3

  • +1 more secondary outcomes

Study Arms (8)

low-dose LYB001 in participants aged 18-59 years

EXPERIMENTAL

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: LYB001

Placebo comparator Ⅰ in participants aged 18-59 years

PLACEBO COMPARATOR

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: Placebo

high-dose LYB001 in participants aged 18-59 years

EXPERIMENTAL

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: LYB001

Placebo comparator Ⅱ in participants aged 18-59 years

PLACEBO COMPARATOR

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: Placebo

low-dose LYB001 in participants aged over 60 years

EXPERIMENTAL

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: LYB001

Placebo comparator Ⅲ in participants aged over 60 years

PLACEBO COMPARATOR

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: Placebo

high-dose LYB001 in participants aged over 60 years

EXPERIMENTAL

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: LYB001

Placebo comparator Ⅳ in participants aged over 60 years

PLACEBO COMPARATOR

Intramuscular injection (IM) at upper arm deltoid on day 0, 28, 56

Biological: Placebo

Interventions

LYB001BIOLOGICAL

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.

high-dose LYB001 in participants aged 18-59 yearshigh-dose LYB001 in participants aged over 60 yearslow-dose LYB001 in participants aged 18-59 yearslow-dose LYB001 in participants aged over 60 years
PlaceboBIOLOGICAL

Aluminum hydroxide

Placebo comparator Ⅰ in participants aged 18-59 yearsPlacebo comparator Ⅱ in participants aged 18-59 yearsPlacebo comparator Ⅲ in participants aged over 60 yearsPlacebo comparator Ⅳ in participants aged over 60 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.).
  • Body mass index within range of 18\~30 kg/m2.

You may not qualify if:

  • 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；
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
  • Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (\>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
  • Currently suffering from or previously diagnosed with infectious diseases, positive screening results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus antibody；
  • History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
  • Asplenia, or functional asplenia；
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Jingwen Qu

CONTACT

+86 15626903973qujingwen@luye.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 18, 2021

Study Start

December 1, 2021

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

November 18, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share