This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.
This phase Ib/IIb trial is designed to evaluate the safety and immunogenicity of different
doses of the Inactivated SARS-CoV-2 Vaccine based upon the randomized, double-blind and
placebo-controlled principle. A total of 471 subjects aged ⩾60 years will be enrolled in the
study, of which 96 and 375 will be enrolled for phase Ib and phase Ⅱb,respectively. The
enrolled subjects in phase Ib receive two doses of low-, medium-, or high-dose of
experimental vaccines or placebo at an interval of 28 days, while the enrolled subjects in
Phase Ⅱb receive two doses of medium, high-dose experimental vaccines or placebo at an
interval of 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: 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: 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: Placebo on a 0- and 28-day schedule
Two doses of placebo at the vaccination schedule of day 0,28
Inclusion Criteria:
- Phase Ib:
1. Healthy people aged ⩾60 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 IIb:
1. Healthy people aged ⩾60 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 Ib:
1. Contraindications for vaccination.
2. History of allergy to vaccines or drugs.
3. Immunization with any vaccine within 1 month.
4. Diseases that cannot be controlled by drugs, such as hypertension, diabetes,
asthma, etc.
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. For any reason, the spleen was removed partially or completely.
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 (≥200 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. Women who have a positive pregnancy test, or men who have a birth plan or plan to
donate sperm 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 IIb:
1. Contraindications for vaccination.
2. History of allergy to vaccines or drugs.
3. Immunization with any vaccine within 1 month.
4. Diseases that cannot be controlled by drugs, such as hypertension, diabetes,
asthma, etc.
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. For any reason, the spleen was removed partially or completely.
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 (≥200 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. Women who have a positive pregnancy test, or men who have a birth plan or plan to
donate sperm from the screening to 12 months after the second vaccination.
13. 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).
14. History of contact with confirmed or suspected cases infected with SARS-CoV-2
within 1 month.
15. 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).
16. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)
screening.
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