This is a randomized, blinded, positive-controlled study to evaluate the safety andimmnunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) LYB001, in population aged18 years old and above. 100 subjects will be recruited in this study, including 50 aged18-59 years old and 50 aged 60 years old and above.
All subjects will be received 3 doses of LYB001, according to the immunization schedule
of 0, 28, 56 days. The adverse events within 28 days after vaccination will be observed.
In addition, blood samples will be collected on day 0 before vaccination,day 14 after
dose 2, and on day 14, 28 and month 3, 6, 9, 12 after full vaccination. Serum antibody
levels, cellular immune responses will be analyzed to evaluate the immunogenicity and
immune persistence of the vaccine.
Biological: low-dose LYB001
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.
Biological: Recombinant COVID-19 Vaccine (CHO Cell)
This vaccine is Positive-controlled vaccine and 3 doses (0.5ml) at the schedule of 0, 28,
56 days.
Biological: high-dose LYB001
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
1. Any acute disease or in the acute phase of chronic diseases within 7 days
before enrollment;
2. Congenital malformation or developmental disorder, genetic defect, severe
malnutrition, etc.;
3. 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;
4. Known diagnosis of or having infectious diseases, or positive for any one of
HBsAg, anti-HCV antibody, anti-TP antibody or anti-HCV antibody;
5. Neurological diseases or family history (convulsion, epilepsy, encephalopathy,
etc.); history of psychosis or family history;
6. Asplenia or functional asplenia;
7. 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;
8. Contraindications of intramuscular injection and blood drawing, such as
coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition
that needs continuous use of anticoagulant;
9. Severe hypertension with uncontrolled medication (at field measurement:
systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)
History of major surgery within 12 weeks before enrollment (in the opinion of
the investigator), or incomplete recovery after surgery, or planning major
surgery during the trial;
- Participating or will participate other clinical trials during this trial;
- Any disease or condition that, in the opinion of the investigator, would pose an
unacceptable risk to the subject; the subject is unable to meet the protocol
requirement; will interfere with evaluation of investigational vaccine.
- Women who were breastfeeding or pregnant during the clinical study or planned to
become pregnant during the study;
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Fengcai Zhu, Principal Investigator
Jiangsu Provincial Center for Disease Control and Prevention