A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SARS-CoV-2 Vaccine (Vero Cells), Inactivated
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.
- Be able to understand and comply with study requirements/ procedures.
- Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection.
- For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose.
- For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening
- Axillary temperature < 37.3℃/99.1℉ when screening (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
Exclusion Criteria:
- Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines).
- History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
- History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)).
- Positive for HIV detection.
- History or family history of convulsion, epilepsy, encephalopathy, and psychosis.
- Active stage of malignancies, malignancies without adequate treatments, malignancies with potential risk for recurrence during the study.
- Severe or uncontrolled cardiovascular, neurological, blood and lymphatic, kidney, liver, respiratory, metabolic and skeletal diseases.
- Congenital or functional absence of spleen, complete or partial removal of spleen in any case.
- Chronic administration (defined as ≥ 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 1st vaccination (eg. corticosteroids, ≥ 0.5 mg/kg/day prednisone or equivalent; but, inhaled and topical steroids are allowed).
- Planned administration/administration of a vaccine not foreseen by the study protocol less than 7 days before 1st dose of candidate vaccine for inactivated vaccines or 14 days before 1st dose of candidate vaccine for attenuated live vaccines.
- Receipt of blood products and/or immunoglobulins within 3 months prior to enrollment or expected receipt during the study.
- Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment, or expected blood donation during the study.
- Fever: axillary temperature ≥ 37.3℃/99.1℉ within the past 24 hours (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
- Those who participated in other clinical trials 1 month prior to the enrollment or used any investigational or non-registered drug during the study period; Those who are unable to finish follow-up or fail in efficacy assessments.
- Breastfeeding females should not be included.
- Ineligible for the study based on the assessment of investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
candidate vaccine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence density of symptomatic COVID-19 cases
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.
Secondary Outcome Measures
Incidence density of COVID-19 moderate cases and above
Incidence density of COVID-19 moderate cases and above occurring from 14 days after full vaccination.
Incidence density of COVID-19 severe cases and above
Incidence density of COVID-19 severe cases and above occurring from 14 days after full vaccination.
Incidence density of COVID-19 death cases and above
Incidence density of COVID-19 death cases and above occurring from 14 days after full vaccination.
Incidence density of symptomatic COVID-19 cases in different age groups
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination in different age groups (18~59 years and ≥ 60 years).
Incidence of solicited local adverse events
Incidence of solicited local adverse events occurring 0-7 days after each vaccination.
Incidence of solicited general adverse events
Incidence of solicited general adverse events occurring 0-7 days after each vaccination.
Incidence of unsolicited adverse events
Incidence of unsolicited adverse events occurring 0-28 days after each vaccination.
Incidence of SAE
Incidence of SAE occurring from the 1st dose through the end of study.
Incidence of AESI
Incidence of AESI occurring from the 1st dose through the end of study.
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Geometric mean titer of SARS-CoV-2 neutralizing antibody
geometric mean titer of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Seroconversion rate of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Geometric mean titer of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Full Information
NCT ID
NCT04852705
First Posted
April 20, 2021
Last Updated
April 20, 2021
Sponsor
Shenzhen Kangtai Biological Products Co., LTD
Collaborators
Beijing Minhai Biotechnology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04852705
Brief Title
A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)
Official Title
A Multi-national, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated for the Prevention of COVID-19 in Healthy Adults Aged 18 Years and Older
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Kangtai Biological Products Co., LTD
Collaborators
Beijing Minhai Biotechnology Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will be a multi-national, endpoint-driven, randomized, double-blind, placebo-controlled, adaptive study in which participating adults will be randomized 1:1 to receive 2 doses of either candidate vaccine or placebo on Day 0 and 28. A total of 28,000 healthy adults aged 18 years and older will be enrolled and followed for efficacy, safety, and immunogenicity evaluations.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
candidate vaccine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 Vaccine (Vero Cells), Inactivated
Intervention Description
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Primary Outcome Measure Information:
Title
Incidence density of symptomatic COVID-19 cases
Description
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination.
Time Frame
14 days after full vaccination
Secondary Outcome Measure Information:
Title
Incidence density of COVID-19 moderate cases and above
Description
Incidence density of COVID-19 moderate cases and above occurring from 14 days after full vaccination.
Time Frame
14 days after full vaccination
Title
Incidence density of COVID-19 severe cases and above
Description
Incidence density of COVID-19 severe cases and above occurring from 14 days after full vaccination.
Time Frame
14 days after full vaccination
Title
Incidence density of COVID-19 death cases and above
Description
Incidence density of COVID-19 death cases and above occurring from 14 days after full vaccination.
Time Frame
14 days after full vaccination
Title
Incidence density of symptomatic COVID-19 cases in different age groups
Description
Incidence density of symptomatic COVID-19 cases occurring from 14 days after full vaccination in different age groups (18~59 years and ≥ 60 years).
Time Frame
14 days after full vaccination
Title
Incidence of solicited local adverse events
Description
Incidence of solicited local adverse events occurring 0-7 days after each vaccination.
Time Frame
0-7 days after each vaccination
Title
Incidence of solicited general adverse events
Description
Incidence of solicited general adverse events occurring 0-7 days after each vaccination.
Time Frame
0-7 days after each vaccination
Title
Incidence of unsolicited adverse events
Description
Incidence of unsolicited adverse events occurring 0-28 days after each vaccination.
Time Frame
0-28 days after each vaccination
Title
Incidence of SAE
Description
Incidence of SAE occurring from the 1st dose through the end of study.
Time Frame
from the 1st dose through the end of study
Title
Incidence of AESI
Description
Incidence of AESI occurring from the 1st dose through the end of study.
Time Frame
from the 1st dose through the end of study
Title
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Description
Seroconversion rate of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time Frame
28 days, 90 days, 180 days and 360 days after full vaccination
Title
Geometric mean titer of SARS-CoV-2 neutralizing antibody
Description
geometric mean titer of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time Frame
28 days, 90 days, 180 days and 360 days after full vaccination
Title
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody
Description
Geometric mean fold increase of SARS-CoV-2 neutralizing antibody in the immunogenicity subgroup
Time Frame
28 days, 90 days, 180 days and 360 days after full vaccination
Title
Seroconversion rate of SARS-CoV-2 IgG binding antibody
Description
Seroconversion rate of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time Frame
28 days, 90 days, 180 days and 360 days after full vaccination
Title
Geometric mean titer of SARS-CoV-2 IgG binding antibody
Description
Geometric mean titer of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time Frame
28 days, 90 days, 180 days and 360 days after full vaccination
Title
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody
Description
Geometric mean fold increase of SARS-CoV-2 IgG binding antibody in the immunogenicity subgroup
Time Frame
28 days, 90 days, 180 days and 360 days after full vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy residents ≥ 18 years at the time of consent, be voluntary and capable of signing the informed consent forms.
Be able to understand and comply with study requirements/ procedures.
Participants with negative results of SARS-CoV-2 Realtime-PCR (RT-PCR) detection.
For females or sex-partners of males at childbearing age: be willing to use birth control for 3 months after the 2nd dose.
For females of childbearing potential (Pausimenia ≤ 2 years ) must: have a negative urine or blood pregnancy test at screening
Axillary temperature < 37.3℃/99.1℉ when screening (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
Exclusion Criteria:
Previous treatments for curing or preventing COVID-19 (including vaccination of various COVID-19 vaccines).
History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
History of allergy to any components of the candidate vaccine or severe allergic reactions to vaccine or medicine (including, but not limited to, allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrosis (Arthus reaction)).
Positive for HIV detection.
History or family history of convulsion, epilepsy, encephalopathy, and psychosis.
Active stage of malignancies, malignancies without adequate treatments, malignancies with potential risk for recurrence during the study.
Severe or uncontrolled cardiovascular, neurological, blood and lymphatic, kidney, liver, respiratory, metabolic and skeletal diseases.
Congenital or functional absence of spleen, complete or partial removal of spleen in any case.
Chronic administration (defined as ≥ 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the 1st vaccination (eg. corticosteroids, ≥ 0.5 mg/kg/day prednisone or equivalent; but, inhaled and topical steroids are allowed).
Planned administration/administration of a vaccine not foreseen by the study protocol less than 7 days before 1st dose of candidate vaccine for inactivated vaccines or 14 days before 1st dose of candidate vaccine for attenuated live vaccines.
Receipt of blood products and/or immunoglobulins within 3 months prior to enrollment or expected receipt during the study.
Donate or loss ≥ 450 ml of blood within 1 month prior to enrollment, or expected blood donation during the study.
Fever: axillary temperature ≥ 37.3℃/99.1℉ within the past 24 hours (Subsequent measurements of temperature should be performed at the same site per participant; temperature measured by other methods should be converted to axillary temperature ).
Those who participated in other clinical trials 1 month prior to the enrollment or used any investigational or non-registered drug during the study period; Those who are unable to finish follow-up or fail in efficacy assessments.
Breastfeeding females should not be included.
Ineligible for the study based on the assessment of investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guifan Li, M.S
Phone
+861059613591
Email
liguifan@biominhai.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Adults Aged 18 Years and Older (COVID-19)
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