Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above

NCT05552573 | Unknown Phase 1 DMC

• 1 other identifier: LYB001/CT-CHN-101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, positive-controlled study to evaluate the safety and immnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above. 100 subjects will be recruited in this study, including 50 aged 18-59 years old and 50 aged 60 years old and above.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse reactions (ARs)

  The incidence of adverse reactions (ARs) within 7 days after each vaccination

  Day 0-7 days after each vaccination

Secondary Outcomes (10)

• The occurrence of adverse events

  Day 0-28 days after each vaccination

• The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs)

  Day 0 to 12 months after dose1, dose2 and dose 3.

• Laboratory safety measures: coagulation, blood biochemistry, complete blood count and urinalysis

  Day 3 after each vaccination.

• Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).

  Day 14 after the second dose, day 14 , day 28 ,month 3, month 6, month 12 after full vaccination.

• Geometric mean fold rise(GMFR) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).

  Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination.

Other Outcomes (1)

• Anti-VLP antibody levels

  Day 14, day 28, month 3, month 6, month 12 after full vaccination.

Study Arms (4)

Low-dose vaccine(18-59 years)

EXPERIMENTAL

3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.

Biological: low-dose LYB001; Biological: Recombinant COVID-19 Vaccine (CHO Cell)

Low-dose vaccine(60 years old and above)

EXPERIMENTAL

3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.

Biological: low-dose LYB001; Biological: Recombinant COVID-19 Vaccine (CHO Cell)

High-dose vaccine(18-59 years)

EXPERIMENTAL

3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.

Biological: Recombinant COVID-19 Vaccine (CHO Cell); Biological: high-dose LYB001

High-dose vaccine(60 years old and above)

EXPERIMENTAL

3 doses of LYB001 or Recombinant COVID-19 Vaccine (CHO Cell) at the immunization schedule of 0, 28, 56 days. Vaccination or positve-controlled group will be randomly assigned to receive in a 4:1 ratio.

Biological: Recombinant COVID-19 Vaccine (CHO Cell); Biological: high-dose LYB001

Interventions

low-dose LYB001 BIOLOGICAL

This vaccine is prepared through gene recombination and 3 doses of low-dose(30µg/0.5ml) LYB001 at the schedule of 0, 28, 56 days.

Low-dose vaccine(18-59 years); Low-dose vaccine(60 years old and above)

Recombinant COVID-19 Vaccine (CHO Cell) BIOLOGICAL

This vaccine is Positive-controlled vaccine and 3 doses (0.5ml) at the schedule of 0, 28, 56 days.

High-dose vaccine(18-59 years); High-dose vaccine(60 years old and above); Low-dose vaccine(18-59 years); Low-dose vaccine(60 years old and above)

high-dose LYB001 BIOLOGICAL

This vaccine is prepared through gene recombination and 3 doses of high-dose(60µg/0.5ml) LYB001 at the schedule of 0, 28, 56 days.

High-dose vaccine(18-59 years); High-dose vaccine(60 years old and above)

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and above.
• Participate the trial voluntarily and sign informed consent form.
• Subjects are willing to comply with the requirements of the clinical trial protocol -and complete the study follow-up.
• Armpit temperature ≤37.0℃ on the day of enrollment.
• Novel Coronavirus (COVID-19) Antibody (IgG and IgM) was negative.

You may not qualify if:

• Known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines
• History of severe acute respiratory syndrome (SARS) and/or Middle East respiratory syndrome (MERS) infection or disease;
• History of COVID-19, or close contact with a confirmed/suspected COVID-19 patient, or SARS-CoV-2 nucleic acid test was positive or antibody test (IgG, IgM) was positive;
• Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
• Has received COVID-19 vaccine;
• vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment;
• Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use during the trial;
• Patients with the following diseases:
• Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment;
• Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
• History of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously\>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids;
• Known diagnosis of or having infectious diseases, or positive for any one of HBsAg, anti-HCV antibody, anti-TP antibody or anti-HCV antibody;
• Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history;
• Asplenia or functional asplenia;
• Serious or uncontrollable cardiovascular diseases, diabetes, hematological and lymphatic diseases, immune system diseases, liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization;

Sponsors & Collaborators

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

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• Tang R, Zeng Y, Zhou Y, Liang Q, Kang W, Yang Z, Zheng X, Zang X, Pan H, Jin J, Zhu F. Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study. Expert Rev Vaccines. 2024 Jan-Dec;23(1):498-509. doi: 10.1080/14760584.2024.2337051. Epub 2024 May 2.

  PMID: 38695310 DERIVED

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

• Fengcai Zhu

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 23, 2022
• Study Start: July 19, 2022
• Primary Completion: January 10, 2023
• Study Completion: December 1, 2023
• Last Updated: March 10, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)