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

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ClinicalTrials.gov Identifier: NCT04659239
Recruitment Status : Unknown
Verified February 2021 by Qihan Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : December 9, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Qihan Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
This is a randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Biological: Placebo Phase 3

Detailed Description:

The trial includes two parts, namely the efficacy study and immunogenicity bridging study. A total of 34020 participants will be enrolled, i.e. 32820 for efficacy cohort, and 1200 for domestic immunogenicity cohort in China.

Efficacy study: Participants will be randomly inoculated with two doses of investigational vaccine or placebo according to 1:1 ratio following Day 0-Day 14 immunization schedule and will be observed from the first dose of investigational vaccine to collect symptomatic and laboratory-confirmed COVID-19 cases for the evaluation of the efficacy of the investigational vaccine.

Immunogenicity bridging study: Before inoculating the first dose, 14 days, 6 months and 12 months after the whole-course immunization, blood samples will be taken for determination of neutralizing antibody and IgG antibody against SARS-CoV-2 (ELISA method); and before inoculating the first dose, 6 months and 12 months after the whole-course immunization, blood samples will be taken for detecting specific T cells with the ELISPOT assay with an aim to evaluate immunogenicity and immune persistence.

Safety observations for all participants will be conducted from the first dose to 28 days after the whole-course immunization, and follow-up of SAEs will also be conducted from the first dose to at least 12 months after the whole-course immunization to evaluate the safety of the investigational vaccine.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded, Placebo Controlled Phase III Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
Actual Study Start Date : January 28, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational Vaccine
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) according to the immunization schedule of D0, D14.
 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
Placebo Comparator: Placebo
Participants will receive 2 doses of the placebo according to the immunization schedule of D0, D14.
 Biological: Placebo
The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: From 14 days after the second dose to 1 year after the second dose. ]
    The incidence of the symptomatic and laboratory-confirmed COVID-19 cases starting from Day 14 after the second dose.

  2. The incidence of solicited AEs. [ Time Frame: 7 days after each dose ]
    The incidence of solicited AEs at the inoculation site (local) and solicited AEs at the non-inoculation site (systemic) within 7 days after each dose


Secondary Outcome Measures :
  1. The incidence of COVID-19 cases after at least one dose of immunization. [ Time Frame: From the first dose to 1 year after the second dose. ]
    The incidence of the symptomatic and laboratory-confirmed COVID-19 cases after at least one dose of immunization.

  2. The Geometric Mean Titer (GMT) of neutralizing antibody [ Time Frame: 14 days after the whole-course immunization ]
    The Geometric Mean Titer (GMT) of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.

  3. The Geometric Mean Titer (GMT) of IgG antibody [ Time Frame: 14 days after the whole-course immunization ]
    The Geometric Mean Titer (GMT) of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.

  4. The positive rates of neutralizing antibody [ Time Frame: 14 days after the whole-course immunization ]
    The positive rates of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.

  5. The positive rates of IgG antibody [ Time Frame: 14 days after the whole-course immunization ]
    The positive rates of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.

  6. The seroconversion rates of neutralizing antibody [ Time Frame: 14 days after the whole-course immunization ]
    The seroconversion rates of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.

  7. The seroconversion rates of IgG antibody [ Time Frame: 14 days after the whole-course immunization ]
    The seroconversion rates of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.

  8. The positive rates of neutralizing antibody [ Time Frame: 6 months and 12 months after whole-course immunization. ]
    The positive rates of neutralizing antibody against SARS-CoV-2 6 months and 12 months after whole-course immunization.

  9. The positive rates of IgG antibody [ Time Frame: 6 months and 12 months after whole-course immunization. ]
    The positive rates of IgG antibody (ELISA method) against SARS-CoV-2 6 months and 12 months after whole-course immunization.

  10. The Geometric Mean Titer (GMT) of neutralizing antibody [ Time Frame: 6 months and 12 months after whole-course immunization. ]
    The Geometric Mean Titer (GMT) of neutralizing antibody against SARS-CoV-2 6 months and 12 months after whole-course immunization.

  11. The Geometric Mean Titer (GMT) of IgG antibody [ Time Frame: 6 months and 12 months after whole-course immunization. ]
    The Geometric Mean Titer (GMT) of IgG antibody (ELISA method) against SARS-CoV-2 6 months and 12 months after whole-course immunization.

  12. Specific T cells with ELISPOT assay [ Time Frame: 6 months and 12 months after the whole-course immunization ]
    Detecting specific T cells with ELISPOT assay 6 months and 12 months after the whole-course immunization

  13. The incidence of AEs [ Time Frame: From the first dose to 28 days after whole-course immunization. ]
    The incidence of AEs from the first dose to 28 days after whole-course immunization

  14. The incidence of SAEs [ Time Frame: From the first dose to at least 12 months after whole-course immunization. ]
    The incidence of SAEs from the first dose to at least 12 months after whole-course immunization.

  15. The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED) [ Time Frame: From 14 days after the second dose to 1 year after the second dose. ]
    The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED) that probably related to the laboratory-confirmed COVID-19 from 14 days after the second dose till the end of trial.


Other Outcome Measures:
  1. The surrogate endpoint of immunogenicity [ Time Frame: From 14 days after the second dose to 1 year after the second dose. ]
    The correlation between the efficacy of the vaccine and the levels of neutralizing antibody and IgG antibody against SARS-CoV-2.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults aged 18 years and above (including boundary values), both female and male.
  2. Legal identification of the participants shall be provided.
  3. Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements.
  4. Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
  5. Participants with oral temperature ≤ 37.9 ℃.

  6. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception:

    1. Condoms (male or female)
    2. Diaphragm with spermicide
    3. Cervical cap with spermicide
    4. Intrauterine device
    5. Oral or patch contraceptives
    6. Any country regulatory-approved contraceptive method that is designed to protect against pregnancy
    7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle (other approaches to abstinence are not acceptable).

Exclusion Criteria:

  1. Contraindications to commonly used vaccines;
  2. History of allergy to any vaccines or drug;
  3. Received any vaccine within 1 month before the first dose of vaccination；
  4. Serious diseases required to be excluded, including but not limited to history of diseases in nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors;
  5. Before immunizing the first dose of investigational vaccine, 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 blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease；
  7. Surgical removal of whole or part of spleen for any reason；
  8. Those who have undergone surgery within 3 months before signing the ICF or those who plan to undergo surgery during or within 3 months after completion of the trial (including plastic 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 plan blood donation during the trial;
  10. Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before signing the ICF, or plan to use them during the study.
  11. Those who received immunosuppressant therapy within 6 months before signing the ICF, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs), but local administration is permitted (such as ointment, eye drops, inhalants, or nasal spray). The local administration should not exceed the recommended dose in the package insert or have any signs of systemic exposure;

  12. Participants cannot meet the criteria through the comprehensive physical examination, mainly including:

    • Abnormal vital signs with clinical significance (awakening heart rate <55 beats/min or >100 beats/min, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
    • Those who tested positive for type 1 or type 2 human immunodeficiency virus (HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;
  13. History of COVID-19;
  14. Participants who have a positive pregnancy test, or are breastfeeding, or planning pregnancy, or plan to donate sperm or eggs within 12 months from the screening period to the whole-course immunization;
  15. Participants who are considered as inappropriate for the trial by investigators.
  16. Suspected or known current alcohol or drug dependency.
  17. Investigator site personnel directly related to this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659239


Locations
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Brazil
CEMEC Pesquisa Clinica
São Bernardo do Campo, São Paulo, Brazil
Malaysia
Hospital Sungai Buloh
Sungai Buloh, Selangor, Malaysia, 47000
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Yasmin binti Mohamed Gani, PhD Hospital Sungai Buloh
Principal Investigator: Adilson JW Cavalcante, PhD CEMEC Pesquisa Clinica
More Information
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Responsible Party: Qihan Li, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04659239    
Other Study ID Numbers: 20200404
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases