Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19

October 8, 2023 updated by: Institute of Medical Biology, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
942

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Second University Hospital, Sichuan University / West China women's and children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low dosage vaccine on a 0- and 28-day schedule
Two doses of low dosage 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 28-day schedule
Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
Experimental: Medium dosage vaccine on a 0- and 28-day schedule
Two doses of medium dosage 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
Experimental: High dosage vaccine on a 0- and 28-day schedule
Two doses of high dosage 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
Placebo Comparator: 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 28-day schedule
Two doses of placebo at the vaccination schedule of day 0,28
Experimental: Low dosage vaccine on a 0- and 14-day schedule
Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
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
Experimental: Medium dosage vaccine on a 0- and 14-day schedule
Two doses of medium dosage 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 14-day schedule
Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Experimental: High dosage vaccine on a 0- and 14-day schedule
Two doses of high dosage 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 14-day schedule
Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
Placebo Comparator: Placebo on a 0- and 14-day schedule
Two doses of placebo at the vaccination schedule of day 0, 14
Biological: Placebo on a 0- and 14-day schedule
Two doses of placebo at the vaccination schedule of day 0,14

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse reactions/events rate
Time Frame: 7 days after vaccination
Occurence of adverse reactions/events after vaccination
7 days after vaccination
Adverse reactions/events rate
Time Frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
28 days after vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
14 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
28 days after the second vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious adverse events
Time Frame: 12 months after the second vaccination
Occurence of Serious adverse events after vaccination
12 months after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time Frame: 7, 14 and 28 days after the second vaccination
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
7, 14 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 and 28 days after the second vaccination
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time Frame: 7, 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
7, 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
14 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time Frame: 7 and 28 days after the second vaccination
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
7 and 28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time Frame: 7 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
7 and 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
28 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time Frame: 14 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time Frame: 14 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
14 days after the second vaccination
Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
28 days after the second vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
Time Frame: 7, 14 and 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
7, 14 and 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
Time Frame: 14 and 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
14 and 28 days after the second vaccination
Level of anti-N protein antibodies Phase Ia (Day 0, 14 schedule)
Time Frame: 7, 14 and 28 days after the second vaccination
Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,14
7, 14 and 28 days after the second vaccination
Level of anti-N protein antibodies Phase IIa (Day 0, 14 schedule)
Time Frame: 14 and 28 days after the second vaccination
Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,14
14 and 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
Time Frame: 7 and 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
7 and 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
28 days after the second vaccination
Level of anti-N protein antibodies Phase Ia (Day 0, 28 schedule)
Time Frame: 7 and 28 days after the second vaccination
Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,28
7 and 28 days after the second vaccination
Level of anti-N protein antibodies Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,28
28 days after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (both schedules)
Time Frame: 3, 6, 9 and 12 months after the second vaccination
Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase Ia immunization schedules
3, 6, 9 and 12 months after the second vaccination
Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (both schedules)
Time Frame: 6 and 12 months after the second vaccination
Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase IIa immunization schedules
6 and 12 months after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase Ia (both schedules)
Time Frame: 3, 6, 9 and 12 months after the second vaccination
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase Ia immunization schedules
3, 6, 9 and 12 months after the second vaccination
Level of IgG antibodies against SARS-CoV-2 Phase IIa (both schedules)
Time Frame: 6 and 12 months after the second vaccination
Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase IIa immunization schedules
6 and 12 months after the second vaccination
Cellular immune responses Phase Ia (Day 0, 14 schedule)
Time Frame: 7, 14 and 28 days after the second vaccination
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
7, 14 and 28 days after the second vaccination
Cellular immune responses Phase IIa (Day 0, 14 schedule)
Time Frame: 14 and 28 days after the second vaccination
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
14 and 28 days after the second vaccination
Cellular immune responses Phase Ia (Day 0, 28 schedule)
Time Frame: 7 and 28 days after the second vaccination
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
7 and 28 days after the second vaccination
Cellular immune responses Phase IIa (Day 0, 28 schedule)
Time Frame: 28 days after the second vaccination
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
28 days after the second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
West China Second University Hospital
Yunnan Center for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoqiang Liu, Yunnan Center For Disease Control and Prevention
  • Principal Investigator: Qin Yu, West China Second University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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