A total of 1200 people aged 18 years and older who have completed two or three-doseinactivated COVID-19 vaccine for 6-18 months will be recruited in this study. Subjectswill be received 1 dose at day 0 as a booster vaccination.Immunogenicity and safety ofRecombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 will be evaluated.
The study is a randomized, double-blind, positive control design and 1200 subjects are
randomly assigned to LYB001 and positive control groups in a 1:1 ratio to evaluate the
safety and immunogenicity as a booster vaccination.
Biological: Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001
Intramuscular injection of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001 in the
deltoid muscle of the upper arm at day 0. The inoculation dose is 0.5 mL.
Biological: ZF2001
Intramuscular injection of ZF2001 in the deltoid muscle of the upper arm at day 0. The
inoculation dose is 0.5 mL.
Inclusion Criteria:
- Healthy subjects aged 18 years and older, 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 been vaccinated with two-dose or three-dose inactivated COVID-19
vaccine for 6-18 months .
- 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.).
Exclusion Criteria:
- Receipt of any COVID-19 prophylactic medication other than inactivated COVID-19
vaccine (e.g., receipt history of any approved or under developing COVID-19
vaccines, or other COVID-19 prophylactic medication, etc.), or previous vaccination
history other than two- or three-dose inactivated COVID-19 vaccination;
- Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or
axillary body temperature ≥ 37.3°C 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 close contact with a confirmed/suspected COVID-19 patient or
positive results for SARS-CoV-2 nucleic acid ;
- 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, monoclonal
antibodies, within 3 months prior to vaccination; or any planned use during the
study period.
- Subjects with the following diseases:
1. Any acute diseases or acute attacks of chronic diseases within 7 days prior to
enrolment;
2. Congenital malformations or developmental disorders, genetic defects, severe
malnutrition, etc.;
3. 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;
4. Currently suffering from or diagnosed with infectious diseases, such as
hepatitis B, hepatitis C, syphilis, AIDS etc.;
5. History or family history of neurological disorders (convulsions, epilepsy,
encephalopathy, etc.) or psychiatric disorders;
6. Asplenia, or functional asplenia;
7. Presence of severe, uncontrollable or hospitalized cardiovascular diseases,
endocrine diseases, blood and lymphatic diseases, immune diseases, liver and
kidney diseases, respiratory diseases, metabolic and skeletal diseases, or
malignant tumors;
8. Contraindications to IM injections and blood draws, such as coagulation
disorders, thrombotic or bleeding disorders, or conditions that needs
continuous anticoagulant usage.
- Drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the
investigator's opinion would compromise the participant's safety or compliance with
the study procedures;
- Pregnant or lactating females;
- Having participated or participating in COVID-19 related clinical trials, and those
participating or planning to participate in other clinical trials during the study
period;
- Presence of any underlying disease or condition which, in the opinion of the
investigator, may place the subject at unacceptable risk, is unable to meet the
requirements of the protocol, or interfere with the assessment of vaccine response
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
Xianfeng Zhang, Principal Investigator
Hubei Provincial Center for Disease Control and Prevention