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

NCT05663086 | Withdrawn Phase 2 DMC

• 1 other identifier: LYB001/CT-CHN-202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, blinded, positive-controlled study to evaluate the immunogenicity and safety of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged 18 years old and above（negative antibody against COVID-19）. 720 subjects will be recruited in this study, including 360 in 1 dose of 30 or 60 μg group and 360 in 2 doses of 30 or 60 μg group. The age group consists of 18-59 years old and 60 years old and above.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain

  GMT of neutralizing antibody against SARS-CoV-2 wild strain at day 14 after full vaccination.

  Day 14 after full vaccination.

Secondary Outcomes (9)

• The occurrence of adverse events

  30 mins,7 days and 28 days after each vaccination

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

  Day 0 to 12 months after dose1and dose2

• Geometric mean titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain

  Day 7 , 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 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination

• Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs).

  Day 7, day 14, day 28 , month 3, month 6, month 12 after full vaccination

Study Arms (3)

Low-dose vaccine

EXPERIMENTAL

30μg LYB001 is to be used in the clinical trial. The number of each arm is 60.

Biological: One dose group; Biological: Two doses group; Biological: Aged 18-59 years; Biological: Aged 60 years old and above

High-dose vaccine

EXPERIMENTAL

60μg LYB001 is to be used in the clinical trial. The number of each arm is 60.

Biological: One dose group; Biological: Two doses group; Biological: Aged 18-59 years; Biological: Aged 60 years old and above

Positive control

ACTIVE COMPARATOR

Positive-controlled vaccine is to be used in the clinical trial. The number of each arm is 60.

Biological: One dose group; Biological: Two doses group; Biological: Aged 18-59 years; Biological: Aged 60 years old and above

Interventions

One dose group BIOLOGICAL

The vaccines are to be administrated at day 0. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

High-dose vaccine; Low-dose vaccine; Positive control

Two doses group BIOLOGICAL

The vaccines are to be administrated at day 0 and 28. Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

High-dose vaccine; Low-dose vaccine; Positive control

Aged 18-59 years BIOLOGICAL

The vaccines are to be administrated in the population of 18-59 years.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

High-dose vaccine; Low-dose vaccine; Positive control

Aged 60 years old and above BIOLOGICAL

The vaccines are to be administrated in the population of 60 years old and above.Low dose or high dose LYB001 or positve-controlled group will be randomly assigned to receive in a 1:1:1 ratio.

High-dose vaccine; Low-dose vaccine; Positive control

Eligibility Criteria

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

You may qualify if:

• People aged 18 years and above who have not received COVID-19 vaccine or whose last vaccination was at least 6 months ago (at the time of screening).
• 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 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) or COVID-19 infection or disease;
• Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
• 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 duringthe 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;
• Positive for anti-AIDS 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;
• Contraindications of intramuscular injection and blood drawing,such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant;
• Severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) .

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

MeSH Terms

Conditions

COVID-19

Interventions

Population Groups; Aging

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Growth and Development; Physiological Phenomena

Study Officials

• Fengcai Zhu

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: December 22, 2022
• First Posted: December 23, 2022
• Study Start: January 7, 2023
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: September 26, 2023

Record last verified: 2022-12

Locations

CN (1)