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

  • STATUS
    Recruiting
  • participants needed
    942
  • sponsor
    Chinese Academy of Medical Sciences
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Updated on 16 February 2024
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covid-19
SARS
acute respiratory syndrome (sars)

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.

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 a,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 a receive two doses of medium, high-dose experimental vaccines or placebo at an interval of 14 or 28 days.

Details
Condition Covid 19
Age 18years - 59years
Treatment 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
Clinical Study IdentifierNCT04412538
SponsorChinese Academy of Medical Sciences
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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