Back to resultsSafety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Placebo on a 0- and 28-day schedule
Placebo on a 0- and 14-day schedule
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
Phase Ia:
- Healthy adults aged 18 to 59 years (including boundary values), both men and women.
- Proven legal identity.
- 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.
- Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
- Axillary temperature ≤37.0 ℃.
Phase IIa:
- Healthy adults aged 18 to 59 years (including boundary values), both men and women.
- Proven legal identity.
- 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.
- Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
- Axillary temperature ≤37.0 ℃.
Exclusion Criteria:
Phase Ia:
- Contraindications for vaccination.
- History of allergy to vaccines or drugs.
- Immunization with any vaccine within 1 month.
- 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.
- Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
- Those who cannot tolerate venipuncture, or have a history of halo needles or halo blood.
- Surgical removal of spleen or other important organs for any reason.
- 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).
- 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.
- 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.
- 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.
- 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.
- Those who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form.
- 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).
- 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).
- 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.
- Positive in drug abuse screening during the screening period (Morphine, Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).
- Positive in alcohol breath test during the screening period.
- Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
- 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).
- History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
- Any other situations judged by investigators as not suitable for participating in this study.
Phase IIa:
- Contraindications for vaccination.
- History of allergy to vaccines or drugs.
- Immunization with any vaccine within 1 month.
- 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.
- Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
- Surgical removal of spleen or other important organs for any reason.
- 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).
- 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.
- 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.
- 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.
- 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).
- 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.
- Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
- 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).
- History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
- Any other situations judged by investigators as not suitable for participating in this study.
Sites / Locations
- West China Second University Hospital, Sichuan University / West China women's and children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Low dosage vaccine on a 0- and 28-day schedule
Low dosage vaccine on a 0- and 14-day schedule
Medium dosage vaccine on a 0- and 28-day schedule
Medium dosage vaccine on a 0- and 14-day schedule
High dosage vaccine on a 0- and 28-day schedule
High dosage vaccine on a 0- and 14-day schedule
Placebo on a 0- and 28-day schedule
Placebo on a 0- and 14-day schedule
Arm Description
Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Two doses of placebo at the vaccination schedule of day 0, 28
Two doses of placebo at the vaccination schedule of day 0, 14
Outcomes
Primary Outcome Measures
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Secondary Outcome Measures
Serious adverse events
Occurence of Serious adverse events after vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Full Information
NCT ID
NCT04412538
First Posted
May 21, 2020
Last Updated
October 8, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
West China Second University Hospital, Yunnan Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04412538
Brief Title
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
West China Second University Hospital, Yunnan Center for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
942 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dosage vaccine on a 0- and 28-day schedule
Arm Type
Experimental
Arm Description
Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Arm Title
Low dosage vaccine on a 0- and 14-day schedule
Arm Type
Experimental
Arm Description
Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Arm Title
Medium dosage vaccine on a 0- and 28-day schedule
Arm Type
Experimental
Arm Description
Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Arm Title
Medium dosage vaccine on a 0- and 14-day schedule
Arm Type
Experimental
Arm Description
Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Arm Title
High dosage vaccine on a 0- and 28-day schedule
Arm Type
Experimental
Arm Description
Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
Arm Title
High dosage vaccine on a 0- and 14-day schedule
Arm Type
Experimental
Arm Description
Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
Arm Title
Placebo on a 0- and 28-day schedule
Arm Type
Placebo Comparator
Arm Description
Two doses of placebo at the vaccination schedule of day 0, 28
Arm Title
Placebo on a 0- and 14-day schedule
Arm Type
Placebo Comparator
Arm Description
Two doses of placebo at the vaccination schedule of day 0, 14
Intervention Type
Biological
Intervention Name(s)
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Intervention Description
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Intervention Type
Biological
Intervention Name(s)
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Intervention Description
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Intervention Type
Biological
Intervention Name(s)
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Intervention Description
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Intervention Type
Biological
Intervention Name(s)
Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Intervention Description
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Intervention Type
Biological
Intervention Name(s)
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
Intervention Description
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Intervention Type
Biological
Intervention Name(s)
High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
Intervention Description
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Intervention Type
Biological
Intervention Name(s)
Placebo on a 0- and 28-day schedule
Intervention Description
Two doses of placebo at the vaccination schedule of day 0,28
Intervention Type
Biological
Intervention Name(s)
Placebo on a 0- and 14-day schedule
Intervention Description
Two doses of placebo at the vaccination schedule of day 0,14
Primary Outcome Measure Information:
Title
Adverse reactions/events rate
Description
Occurence of adverse reactions/events after vaccination
Time Frame
7 days after vaccination
Title
Adverse reactions/events rate
Description
Occurence of adverse reactions/events after vaccination
Time Frame
28 days after vaccination
Title
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Description
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Time Frame
14 days after the second vaccination
Title
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Description
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Title
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Description
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Time Frame
14 days after the second vaccination
Title
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Description
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Secondary Outcome Measure Information:
Title
Serious adverse events
Description
Occurence of Serious adverse events after vaccination
Time Frame
12 months after the second vaccination
Title
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Description
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Time Frame
7, 14 and 28 days after the second vaccination
Title
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Description
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Time Frame
14 and 28 days after the second vaccination
Title
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Description
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Time Frame
7, 14 and 28 days after the second vaccination
Title
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Description
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Time Frame
14 and 28 days after the second vaccination
Title
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Description
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Time Frame
7 and 28 days after the second vaccination
Title
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Description
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Title
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Description
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Time Frame
7 and 28 days after the second vaccination
Title
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Description
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Title
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Description
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Time Frame
14 days after the second vaccination
Title
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Description
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Time Frame
14 days after the second vaccination
Title
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Description
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Title
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Description
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Other Pre-specified Outcome Measures:
Title
Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Description
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Time Frame
7, 14 and 28 days after the second vaccination
Title
Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Description
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Time Frame
14 and 28 days after the second vaccination
Title
Level of anti-N protein antibodies Phase Ia (Day 0, 14 schedule)
Description
Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,14
Time Frame
7, 14 and 28 days after the second vaccination
Title
Level of anti-N protein antibodies Phase IIa (Day 0, 14 schedule)
Description
Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,14
Time Frame
14 and 28 days after the second vaccination
Title
Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Description
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Time Frame
7 and 28 days after the second vaccination
Title
Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Description
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Title
Level of anti-N protein antibodies Phase Ia (Day 0, 28 schedule)
Description
Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,28
Time Frame
7 and 28 days after the second vaccination
Title
Level of anti-N protein antibodies Phase IIa (Day 0, 28 schedule)
Description
Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
Title
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (both schedules)
Description
Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase Ia immunization schedules
Time Frame
3, 6, 9 and 12 months after the second vaccination
Title
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (both schedules)
Description
Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase IIa immunization schedules
Time Frame
6 and 12 months after the second vaccination
Title
Level of IgG antibodies against SARS-CoV-2 Phase Ia (both schedules)
Description
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase Ia immunization schedules
Time Frame
3, 6, 9 and 12 months after the second vaccination
Title
Level of IgG antibodies against SARS-CoV-2 Phase IIa (both schedules)
Description
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase IIa immunization schedules
Time Frame
6 and 12 months after the second vaccination
Title
Cellular immune responses Phase Ia (Day 0, 14 schedule)
Description
Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,14
Time Frame
7, 14 and 28 days after the second vaccination
Title
Cellular immune responses Phase IIa (Day 0, 14 schedule)
Description
Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,14
Time Frame
14 and 28 days after the second vaccination
Title
Cellular immune responses Phase Ia (Day 0, 28 schedule)
Description
Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,28
Time Frame
7 and 28 days after the second vaccination
Title
Cellular immune responses Phase IIa (Day 0, 28 schedule)
Description
Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,28
Time Frame
28 days after the second vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Phase Ia:
Healthy adults aged 18 to 59 years (including boundary values), both men and women.
Proven legal identity.
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.
Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
Axillary temperature ≤37.0 ℃.
Phase IIa:
Healthy adults aged 18 to 59 years (including boundary values), both men and women.
Proven legal identity.
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.
Participants should be able to communicate well with investigators, understand and comply with the requirements of this trial.
Axillary temperature ≤37.0 ℃.
Exclusion Criteria:
Phase Ia:
Contraindications for vaccination.
History of allergy to vaccines or drugs.
Immunization with any vaccine within 1 month.
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.
Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
Those who cannot tolerate venipuncture, or have a history of halo needles or halo blood.
Surgical removal of spleen or other important organs for any reason.
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).
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.
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.
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.
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.
Those who smoked more than 5 cigarettes per day within 3 months before signing the informed consent form.
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).
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).
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.
Positive in drug abuse screening during the screening period (Morphine, Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).
Positive in alcohol breath test during the screening period.
Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
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).
History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
Any other situations judged by investigators as not suitable for participating in this study.
Phase IIa:
Contraindications for vaccination.
History of allergy to vaccines or drugs.
Immunization with any vaccine within 1 month.
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.
Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
Those who have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis or bleeding disorders.
Surgical removal of spleen or other important organs for any reason.
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).
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.
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.
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.
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).
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.
Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM) screening.
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).
History of contact with confirmed or suspected cases infected with SARS-CoV-2 within 1 month.
Any other situations judged by investigators as not suitable for participating in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qin Yu
Organizational Affiliation
West China Second University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoqiang Liu
Organizational Affiliation
Yunnan Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Second University Hospital, Sichuan University / West China women's and children's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33875266
Citation
Pu J, Yu Q, Yin Z, Zhang Y, Li X, Yin Q, Chen H, Long R, Zhao Z, Mou T, Zhao H, Feng S, Xie Z, Wang L, He Z, Liao Y, Fan S, Jiang R, Wang J, Zhang L, Li J, Zheng H, Cui P, Jiang G, Guo L, Xu M, Yang H, Lu S, Wang X, Gao Y, Xu X, Cai L, Zhou J, Yu L, Chen Z, Hong C, Du D, Zhao H, Li Y, Ma K, Ma Y, Liu D, Yao S, Li C, Che Y, Liu L, Li Q. The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18-59 years: A phase I randomized, double-blinded, controlled trial. Vaccine. 2021 May 12;39(20):2746-2754. doi: 10.1016/j.vaccine.2021.04.006. Epub 2021 Apr 9.
Results Reference
derived
PubMed Identifier
33165503
Citation
Che Y, Liu X, Pu Y, Zhou M, Zhao Z, Jiang R, Yin Z, Xu M, Yin Q, Wang J, Pu J, Zhao H, Zhang Y, Wang L, Jiang Y, Lei J, Zheng Y, Liao Y, Long R, Yu L, Cui P, Yang H, Zhang Y, Li J, Chen W, He Z, Ma K, Hong C, Li D, Jiang G, Liu D, Xu X, Fan S, Cheng C, Zhao H, Yang J, Li Y, Zou Y, Zhu Y, Zhou Y, Guo Y, Yang T, Chen H, Xie Z, Li C, Li Q. Randomized, Double-Blinded, Placebo-Controlled Phase 2 Trial of an Inactivated Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine in Healthy Adults. Clin Infect Dis. 2021 Dec 6;73(11):e3949-e3955. doi: 10.1093/cid/ciaa1703.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
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