Safety and Immunogenicity of Recombinant COVID-19 Trivalent Protein Vaccine （CHO Cell）LYB002V14 in Booster Vaccination

NCT06167915 | Unknown Phase 1 DMC

• 1 other identifier: LYB002V14/CT-CHN-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, and dose escalation phase I trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of Recombinant COVID-19 Trivalent (XBB.1+BQ.1.1+Prototype) Protein Vaccine （CHO Cell）（LYB002V14）.

Conditions

SARS-CoV-2; COVID-19 Vaccine

Outcome Measures

Primary Outcomes (1)

• Adverse events and adverse reactions

  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.

  Day 0 to Day 7

Secondary Outcomes (7)

• Adverse events and adverse reactions

  Day 0 to Day 28

• Serious Adverse Events （SAEs） and Adverse Events of Special Interest （AESI）

  Day 0 to Month 12

• Laboratory test and vital signs related adverse events.

  Day 0 to Day 3

• Geometric mean titer （GMT）, Geometric Mean Fold Rise （GMFR） and seroconversion rate （SCR） of neutralizing antibodies （nAb） against variants of concern circulating during the trial.

  Day 14、Day 28、Month 3 and Month 6

• GMT, GMFR and SCR of nAb against Omicron subvariant （XBB）

  Day 14、Day 28、Month 3 and Month 6

Study Arms (3)

Low dose vaccine group

EXPERIMENTAL

30μg dose of LYB002V14 vaccine IM, on day 0.

Biological: 30μg dose of LYB002V14

High dose vaccine group

EXPERIMENTAL

60μg dose of LYB002V14 vaccine IM, on day 0.

Biological: 60μg dose of LYB002V14

Placebo group

PLACEBO COMPARATOR

placebo IM, on day 0.

Biological: placebo

Interventions

30μg dose of LYB002V14 BIOLOGICAL

30μg dose of LYB002V14 vaccine IM, on day 0

Low dose vaccine group

60μg dose of LYB002V14 BIOLOGICAL

60μg dose of LYB002V14 vaccine IM, on day 0

High dose vaccine group

placebo BIOLOGICAL

placebo IM, on day 0

Placebo group

Eligibility Criteria

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

You may qualify if:

• Subjects aged 18 years and above when screening.
• Participate voluntarily and sign an informed consent form and have the ability to understand research procedures.
• Negative SARS-CoV-2 nucleic acid test and SARS-CoV-2 IgM test.
• Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment.
• Without a history of SARS-CoV-2 infection or known SARS-CoV-2 infection more than 3 months prior to screening.
• Fertile women take effective contraceptive measures 1 month before enrollment; Fertile women (except those received hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy) and men of childbearing potential voluntarily agree to take effective contraceptive measures from screening to 3 months after vaccination and without a plan of pregnancy and germ cell donation.

You may not qualify if:

• Have a known allergy, hypersensitivity, or intolerance to the planned investigational vaccine including any excipients of the vaccine. Have a known anaphylactic shock and other serious adverse events to other vaccine.
• Have a known history of SARS and MERS.
• Administration of antipyretics, painkillers or anti-allergy drugs within 24 hours prior to enrolment.
• Receipt of subunit and/or inactivated vaccine within 7 days prior to vaccination or receipt of any live attenuated vaccine within 14 days prior to vaccination.
• History of SARS-CoV-2 vaccination within 3 months prior to enrollment; Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study.
• Participants with the following diseases: ①Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment. ②Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. ③Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (\>14 immunosuppressive agents within the past 6 months with exception of inhaled or topical steroids, or short-term use （≤14 consecutive days） of oral corticosteroids. ④Currently suffering from or diagnosed with infectious diseases, or positive screening results for human immunodeficiency virus antibody. ⑤History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders. ⑥Asplenia, or functional asplenia. ⑦Presence of severe, uncontrollable or hospitalized cardiovascular diseases, diabetes, blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors. ⑧Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage. ⑨Hypertension not controlled by medication (on-site measurement: systolic blood pressure ≥ 160mmHg and / or diastolic blood pressure ≥ 100mmHg).
• Have a history of major surgery within 3 months before enrollment （based on the judgment of the researchers）, or has not yet fully recovered from the surgery, or has a major surgical plan during the study.
• Those participating or planning to participate in other clinical trials during the study period.
• Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse or confound the study results, or non-conformance with the maximal benefits of the participants.

Sponsors & Collaborators

• Guangzhou Patronus Biotech Co., Ltd.: lead
• Yantai Patronus Biotech Co., Ltd.: collaborator

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Study Officials

• Qin Yu, Master

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qin Yu, Master

CONTACT

18980602109; 908929936@qq.com

Study Design

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

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 13, 2023
• Study Start: December 26, 2023
• Primary Completion: December 26, 2024
• Study Completion: December 31, 2024
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)