Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yantai Patronus Biotech Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of adverse events | The occurrence of adverse events within 28 days after vaccination | Day 0-28 days after each vaccination |
| The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-VLP antibody levels | Anti-VLP antibody levels at day 14, day 28, month 3, month 6, month 12 after full vaccination. | Day 14, day 28, month 3, month 6, month 12 after full vaccination. |
Inclusion Criteria:
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:
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;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38695310 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 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. |
|
The incidences of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months after dose1, dose2 and dose 3.
| Day 0 to 12 months after dose1, dose2 and dose 3. |
| Laboratory safety measures: coagulation, blood biochemistry, complete blood count and urinalysis | The change of laboratory safety measures on day 3 after each vaccination in comparison with that before vaccination. | Day 3 after each vaccination. |
| Geometric neutralizing titers (GMT) of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs). | GMT of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28 , month 3, month 6, month 12 after full vaccination. | 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). | GMFR of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination. | Day 14 after the second dose, 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). | Seroconversion rate of neutralizing antibody against SARS-CoV-2 wild strain and variants of concern(VOCs) at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination. | Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination. |
| GMT of binding antibody against S protein of SARS-CoV-2 wild strain. | GMT of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination. | Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination. |
| GMFR of binding antibody against S protein of SARS-CoV-2 wild strain. | GMFR of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination. | Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination. |
| Seroconversion rate of of binding antibody against S protein of SARS-CoV-2 wild strain. | Seroconversion rate of binding antibody against S protein of SARS-CoV-2 wild strain at day 14 after the second dose, day 14 ,day 28, month 3, month 6, month 12 after full vaccination. | Day 14 after the second dose, day 14, day 28, month 3, month 6, month 12 after full vaccination. |
| The cytokine levels (Elispot): Th1 type: IL-2, IFN-γ; Th2 type: IL-4. | The cytokine levels (Elispot) at day 14 after the second dose, day 14 after full vaccination. | Day 14 after the second dose, day 14 after full vaccination. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |