This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18~59 Years.
This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different
doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules
based upon the randomized, double-blind and placebo-controlled principle. A total of 942
subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be
enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two
doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14
or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose
experimental vaccines or placebo at an interval of 14 or 28 days.
Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Biological: Placebo on a 0- and 28-day schedule
Two doses of placebo at the vaccination schedule of day 0,28
Biological: Placebo on a 0- and 14-day schedule
Two doses of placebo at the vaccination schedule of day 0,14
Inclusion Criteria:
- Phase Ia:
1. Healthy adults aged 18 to 59 years (including boundary values), both men and
women.
2. Proven legal identity.
3. Participants should understand the contents of the informed consent form, the
vaccine in this trial, voluntarily sign the informed consent form, and be capable
of using thermometers, scales, and filling in diary cards and contact cards as
required.
4. Participants should be able to communicate well with investigators, understand
and comply with the requirements of this trial.
5. Axillary temperature ≤37.0 ℃.
- Phase IIa:
1. Healthy adults aged 18 to 59 years (including boundary values), both men and
women.
2. Proven legal identity.
3. Participants should understand the contents of the informed consent form, the
vaccine in this trial, voluntarily sign the informed consent form, and be capable
of using thermometers, scales, and filling in diary cards and contact cards as
required.
4. Participants should be able to communicate well with investigators, understand
and comply with the requirements of this trial.
5. Axillary temperature ≤37.0 ℃.
Exclusion Criteria:
- Phase Ia:
1. Contraindications for vaccination.
2. History of allergy to vaccines or drugs.
3. Immunization with any vaccine within 1 month.
4. History of abnormal clinical manifestations and serious diseases to be excluded,
including but not limited to nervous system, cardiovascular system, blood and
lymphatic system, immune system, kidney, liver, gastrointestinal tract,
respiratory system, metabolism, bones and other system diseases, and a history of
malignant tumors.
5. Those who developed acute disease within 2 weeks, or had symptoms of fever or
upper respiratory tract infection within 7 days.
6. Those who have a hereditary bleeding tendency or coagulation dysfunction, or a
history of thrombosis or bleeding disorders.
7. Those who cannot tolerate venipuncture, or have a history of halo needles or halo
blood.
8. Surgical removal of spleen or other important organs for any reason.
9. Those who have undergone surgery within 3 months before signing the informed
consent, or those who plan to perform surgery during the trial or within 3 months
after the end of the trial (including cosmetic surgery, dental and oral surgery).
10. Those who donated or lost blood (≥400 mL) in the past 3 months, who received
blood transfusion or use of blood products, or who planned blood donation during
the trial.
11. Receipt of other investigational or unregistered products (drugs, vaccines,
biological product or devices) in the past 3 months, or plan to use other
investigational or unregistered products during the study.
12. Receipt of immunosuppressive therapy within 6 months before signing the informed
consent form, such as long-term systemic glucocorticoid therapy (with systemic
glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone
or similar drugs) ), but local administration (such as ointment, eye drops,
inhalation, or nasal spray) is allowed. The local administration should not
exceed the dosage recommended in the instructions or have any signs of systemic
exposure.
13. Those who have took soft drugs (such as marijuana) within 3 months before signing
the informed consent form or took hard drugs (such as: cocaine, phencyclidine,
etc.) within 1 year before the trial.
14. Those who smoked more than 5 cigarettes per day within 3 months before signing
the informed consent form.
15. The weekly drinking volume is greater than 14 units within 3 months before
signing the informed consent form (1 unit alcohol approximately equal to 360 mL
beer or 45 mL spirits with 40% alcohol content or 150 mL wine).
16. The comprehensive physical examination does not meet the health standards, mainly
including: (1) Those with abnormal vital signs with clinical significance. (2)
BMI<18 kg/m^2 or> 30 kg/m^2. (3) Abnormal laboratory examination with clinical
significance. (4) Those who tested positive for human immunodeficiency virus
(HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C
virus antibody, or Treponema pallidum antibody (tp-trust).
17. Participants who have a positive pregnancy test, or are breastfeeding, or plan to
become pregnant, or plan to donate sperm or eggs from the screening to 12 months
after the second vaccination.
18. Positive in drug abuse screening during the screening period (Morphine,
Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).
19. Positive in alcohol breath test during the screening period.
20. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)
screening.
21. History of severe acute respiratory syndrome (SARS) or Middle East respiratory
syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,
HCoV-HKU1).
22. History of contact with confirmed or suspected cases infected with SARS-CoV-2
within 1 month.
23. Any other situations judged by investigators as not suitable for participating in
this study.
- Phase IIa:
1. Contraindications for vaccination.
2. History of allergy to vaccines or drugs.
3. Immunization with any vaccine within 1 month.
4. History of abnormal clinical manifestations and serious diseases to be excluded,
including but not limited to nervous system, cardiovascular system, blood and
lymphatic system, immune system, kidney, liver, gastrointestinal tract,
respiratory system, metabolism, bones and other system diseases, and a history of
malignant tumors.
5. Those who developed acute disease within 2 weeks, or had symptoms of fever or
upper respiratory tract infection within 7 days.
6. Those who have a hereditary bleeding tendency or coagulation dysfunction, or a
history of thrombosis or bleeding disorders.
7. Surgical removal of spleen or other important organs for any reason.
8. Those who have undergone surgery within 3 months before signing the informed
consent, or those who plan to perform surgery during the trial or within 3 months
after the end of the trial (including cosmetic surgery, dental and oral surgery).
9. Those who donated or lost blood (≥400 mL) in the past 3 months, who received
blood transfusion or use of blood products, or who planned blood donation during
the trial.
10. Receipt of other investigational or unregistered products (drugs, vaccines,
biological product or devices) in the past 3 months, or plan to use other
investigational or unregistered products during the study.
11. Receipt of immunosuppressive therapy within 6 months before signing the informed
consent form, such as long-term systemic glucocorticoid therapy (with systemic
glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone
or similar drugs) ), but local administration (such as ointment, eye drops,
inhalation, or nasal spray) is allowed. The local administration should not
exceed the dosage recommended in the instructions or have any signs of systemic
exposure.
12. The comprehensive physical examination does not meet the health standards, mainly
including: (1) Those with abnormal vital signs (Pulse <55 beats per minute or>
100 beats per minute at rest, Systolic blood pressure ≥140mmHg or Diastolic blood
pressure ≥90mmHg, breathing> 20 beats per minute or <12 beats per minute). (2)
Those who tested positive for human immunodeficiency virus (HIV) antibody,
hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody,
or Treponema pallidum antibody (tp-trust).
13. Participants who have a positive pregnancy test, or are breastfeeding, or plan to
become pregnant, or plan to donate sperm or eggs from the screening to 12 months
after the second vaccination.
14. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)
screening.
15. History of severe acute respiratory syndrome (SARS) or Middle East respiratory
syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,
HCoV-HKU1).
16. History of contact with confirmed or suspected cases infected with SARS-CoV-2
within 1 month.
17. Any other situations judged by investigators as not suitable for participating in
this study.
West China Second University Hospital, Sichuan University / West China women's and children's Hospital
Chengdu, Sichuan, China
Investigator: Qin Yu
Contact: 86-028-85501952
908929936@qq.com
Qihan Li, PhD
86-0871-68335905
liqihan@imbcams.com
Yanchun Che, Researcher
86-0871-68335905
cheyanchun@imbcams.com