The Safety and Immunogenicity Following a Heterologous Booster Dose of Recombinant SARS-CoV-2 Vaccine LYB002

NCT05928468 | Unknown Early Phase 1 DMC

• 1 other identifier: LYB002/CT-CHN-IIT02
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, humoral immunogenicity, cellular immunogenicity and immune persistence following a heterologous booster dose of recombinant SARS-CoV-2 trivalent vaccine (CHO Cell) LYB002 in Chinese adults 18 years and above completed three-dose Inactivated COVID-19 vaccine;

Conditions

COVID-19

Outcome Measures

Primary Outcomes (9)

• The frequencies and percentages of adverse events within 30 minutes of each booster dose

  Statistical description of solicited and unsolicited adverse events (AEs) will be listed.Frequencies and percentages of AEs, including overall AEs, AEs related tovaccination, AEs classified as grade 3 or worse, AEs classified as grade 3 or worsethat related to vaccination, AEs leading to participant's withdrawal, AEs leading toparticipant's withdrawal that related to vaccination will be presented. Fisher's exacttest 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 of each booster dose

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

  7 days after booster vaccination

• The frequencies and percentages of adverse events within 28 days of each booster dose

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

  28 days after booster vaccination

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

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

  14 days after each booster vaccination

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

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

  28 days after each booster vaccination

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

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

  14 days after each booster vaccination

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

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

  28 days after each booster vaccination

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

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

  14 days after each booster vaccination

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

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

  28 days after each booster vaccination

Secondary Outcomes (5)

• The Seroconversion (SCRs) of neutralizing antibodies (Nabs) and S protein-binding

  3 months after the last booster vaccination

• The Geometric Neutralizing titers (GMT) of neutralizing antibodies (Nabs) and GMC of Sprotein-binding antibodies

  3 months after the last booster vaccination

• The Geometric mean fold rise (GMFR) of neutralizing antibodies (Nabs) and S protein-binding antibodies

  3 months after the last booster vaccination

• The frequencies and percentages of adverse events

  6 months after the last booster vaccination

• The changes of the frequencies and percentages of adverse events from the baseline at the 3rd day after each boost vaccination

  3 days after each booster vaccination

Other Outcomes (1)

• The counts of spot forming cells (SFCs) per 3×105 peripheral blood mononuclear cells(PBMCs) of Cellular immunity

  14 days after each booster vaccination

Study Arms (3)

LYB002V14

EXPERIMENTAL

The vaccine LYB002V14 was administered through intramuscular injection.

Biological: LYB002V14

LYB002V14A

ACTIVE COMPARATOR

The vaccine LYB002V14A was administered through intramuscular injection.

Biological: LYB002V14A

LYB002CA

ACTIVE COMPARATOR

The vaccine LYB002CA was administered through intramuscular injection.

Biological: LYB002CA

Interventions

LYB002V14 BIOLOGICAL

Participants receiving one or two boost doses of LYB002V14 after a three-dose primary series of inactivated COVID-19 vaccine.

LYB002V14

LYB002V14A BIOLOGICAL

Participants receiving one or two boost doses of LYB002V14A after a three-dose primary series of inactivated COVID-19 vaccine.

LYB002V14A

LYB002CA BIOLOGICAL

Participants at 18-59 years old receiving two boost doses of LYB002CA after a three-dose primary series of inactivated COVID-19 vaccine.

LYB002CA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 three-dose inactivated COVID-19 vaccine at 6 months earlier;
• S-protein binding antibody IgG concentration was less than 300BAU/mL before booster vaccination in cohort 1, while S-protein binding antibody IgG concentration was not screened in cohort 2; Subjects in cohort 1 and cohort 2 were negative in nucleic acid test or antigen test before booster vaccination.
• 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, or previous vaccination history other than other than three doses of inactivated vaccination;
• Abnormal vital signs with clinical significance prior to enrolment, systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg for subjects aged ≥60 years), or axillary body temperature ≥37.3℃;
• The results of laboratory tests before enrollment were abnormal and clinically significant as judged by clinicians;
• 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);
• 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)

Affiliated Hospital of North Sichuan MedicalCollege

Chengdu, Sichuan, 610055, China

Location

MeSH Terms

Conditions

COVID-19

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

  Affiliated Hospital to North Sichuan MedicalCollege

  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

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 3, 2023
• Study Start: April 25, 2023
• Primary Completion: July 31, 2023
• Study Completion: November 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)