The Immunogenicity and Safety Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB001

NCT05928455 | Unknown Early Phase 1 DMC

• 1 other identifier: MLD-C-22001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the immunogenicity and safety following a heterologous booster dose of recombinant SARS-CoV-2 vaccine (CHO cell) LYB001 in adults 18-59 years of age completed two- or three-dose inactivated COVID-19 vaccine. The main questions it aims to answer are:

• whether LYB001 group is better on immunogenicity than the control group of inactivated vaccine?
• whether LYB001 group has better performance on safety than the control group of inactivated vaccine, such as the lower adverse reaction rate?

Conditions

COVID-19; Vaccine Reaction

Keywords

Safety; immunogenicity; heterologous booster; inactivated COVID-19 vaccine; recombinant SARS-CoV-2 vaccine

Outcome Measures

Primary Outcomes (9)

• The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization

  The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, respectively.

  14 days after booster vaccination

• The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization

  The Seroconversion (SCRs) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, respectively.

  28 days after booster vaccination

• The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after booster vaccination

  The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, respectively.

  14 days after booster vaccination

• The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after booster vaccination

  The Geometric Neutralizing titers (GMT) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, respectively.

  28 days after booster vaccination

• The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 14 days after the booster immunization compared with the baseline

  The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 14 days after the booster immunization will be calculated for each group, compared with the baseline, respectively.

  14 days after booster vaccination

• The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 28 days after the booster immunization compared with the baseline

  The Geometric mean fold rise (GMFR) with Clopper-Pearson 95% CIs of neutralizing antibodies (Nabs) against prototype SARS-CoV-2 and circulating VOCs using Vesicular stomatitis virus (VSV)-based pseudovirus neutralizing assays, S protein-binding antibodies using ELISA assays, at 28 days after the booster immunization will be calculated for each group, compared with the baseline, respectively.

  28 days after booster vaccination

• The frequencies and percentages of adverse events within 30 minutes after booster vaccination

  Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups. Solicited and unsolicited AEs within 30 mins after vaccination will be collected.

  within 30 minutes after booster vaccination

• The frequencies and percentages of adverse events within 7 days after booster vaccination

  Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups. Solicited and unsolicited AEs within 7 days after vaccination will be collected.

  within 7 days after booster vaccination

• The frequencies and percentages of unsolicitedadverse events within 8-28 days after booster vaccination

  Statistical description of solicited and unsolicited adverse events (AEs) will be listed. Frequencies and percentages of AEs, including overall AEs, AEs related to vaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worse that related to vaccination, AEs leading to participant's withdrawal, AEs leading to participant's withdrawal that related to vaccination will be presented. Fisher's exact test will be used to compare the differences between the groups. Unsolicited AEs within 8-28 days after vaccination will be collected.

  within 8-28 days after booster vaccination

Secondary Outcomes (9)

• The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 3 months after booster vaccination

  3 months after booster vaccination

• The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 6 months after booster vaccination

  6 months after booster vaccination

• The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding at 12 months after booster vaccination

  12 months after booster vaccination

• The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 3 months after booster vaccination

  3 months after booster vaccination

• The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and S protein-binding antibodies at 6 months after booster vaccination

  6 months after booster vaccination

Other Outcomes (2)

• The counts of spot forming cells (SFCs) per 3×105 peripheral blood mononuclear cells (PBMCs) at 14 days after booster vaccination

  14 days after booster vaccination

• The counts of spot forming cells (SFCs) per 3×105 peripheral blood mononuclear cells (PBMCs) at 180 days after booster vaccination

  180 days after booster vaccination

Study Arms (2)

LYB001

EXPERIMENTAL

Participants receiving a boost with 30ug or 60ug LYB001 after a two-or three-dose primary series of inactivated COVID-19 vaccine.

Biological: LYB001

CoronaVac

ACTIVE COMPARATOR

Participants receiving a boost with vaccine CoronaVac after a two-or three-dose primary series of inactivated COVID-19 vaccine.

Biological: CoronaVac

Interventions

LYB001 BIOLOGICAL

Experimental: The LYB001 vaccine was administered through intramuscular injection at doses of 30ug or 60ug in a 0.5mL volume.

LYB001

CoronaVac BIOLOGICAL

Active Comparator: The CoronaVac vaccine was administered through intramuscular injection in a 0.5mL volume.

CoronaVac

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects aged 18-59 years, including both males and females;
• 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.
• Subjects who have completed two- or three-dose inactivated COVID-19 vaccine at 6-12 months earlier.
• 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.).

You may not qualify if:

• Receipt of any COVID-19 prophylactic medication (e.g., receipt history of any approved or under developing COVID-19 vaccines other than inactivated vaccine), or previous vaccination history other than other than two or three doses of inactivated vaccination;
• Abnormal vital signs with clinical significance prior to enrolment, with systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, or axillary body temperature ≥ 37.3°C prior to enrolment; abnormal results of laboratory screening tests which was clinically significant judged by clinicians prior to enrolment.
• Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;
• History of 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 SARS-CoV-2 nucleic acid tests at screening;
• Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment;
• Receipt of any live attenuated vaccine within 28 days prior to vaccination and other vaccines, such as subunit and inactivated 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 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；

Sponsors & Collaborators

• Guangzhou Patronus Biotech Co., Ltd.: lead
• Yantai Patronus Biotech Co., Ltd.: collaborator
• Affiliated Hospital of North Sichuan Medical College: collaborator

Study Sites (1)

Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College

Chengdu, Sichuan, 610055, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaolan Yong, Bachelor

  Chengdu Xinhua Hospital Affiliated to North Sichuan Medical College, Chengdu, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open label, positive control (Stage Ⅰ); Single-arm, open-label (Stage Ⅱ)

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 3, 2023
• Study Start: May 14, 2022
• Primary Completion: October 10, 2022
• Study Completion: June 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)