search
Back to results

Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)

Primary Purpose

COVID-19

Status
Active
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
CoronaVac
Placebo
Sponsored by
Health Institutes of Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2 Vaccine

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-59 years of age (including 18 and 59 years of ages),
  • For only K1 cohort, health care workers such as medical doctor, nurse, ward boy, cleaner, hospital technician, administrative personnel who work in any department of a hospital.
  • Signed informed consent

Exclusion Criteria:

  • Previously PCR positive for COVID-19
  • IgG or IgM is positive
  • For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination
  • Known allergy to components of the study vaccine or control
  • Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study or planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others
  • Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant
  • History of asplenia
  • History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
  • Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history
  • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
  • Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment
  • Received live attenuated virus vaccine 14 days prior to enrollment in the study
  • Inactivated vaccine or sub unit vaccine 7 days prior to enrollment in the study
  • Fever (oral temperature >37.2℃, axillary temperature will not be accepted) within the past 24 hours
  • Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
  • Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection.

Sites / Locations

  • T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
  • T.R. Ministry of Health Ankara Provincial Health Directorate Ankara Training and Research Hospital, Infectious Diseases
  • Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  • Çukurova University Faculty of Medicine, Department of Infectious Diseases
  • Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology
  • T.C Ministry of Health Ankara Provincial Health Directorate Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
  • Akdeniz University Faculty of Medicine, Department of Infectious Diseases
  • Bursa Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  • Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  • Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  • Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology
  • Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
  • Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine
  • Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  • T.R. Ministry of Health Istanbul Provincial Health Directorate Marmara Univesity Istanbul Pendik Education and Research Hospital
  • T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic
  • T.R. Ministry of Health Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
  • University of Health Sciences İstanbul Ümraniye Training and Research Hospital
  • Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases
  • Republic Of Turkey Ministry Of Health Izmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital
  • T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
  • T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
  • Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
  • Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
  • Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SARS-COV-2 Vaccine

Placebo

Arm Description

600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart.

Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart.

Outcomes

Primary Outcome Measures

Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19

Secondary Outcome Measures

Protection Indexes of One Vaccine Dose For Symptomatic COVID-19
The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.
Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination
Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection
The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination
Safety indexes of adverse reactions in 28 days
The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.
Safety indexes of adverse reactions in 7 days
The incidence of adverse reactions within 7 days after each dose of vaccination
Safety indexes of serious adverse events in 1 year
The incidence of SAEs from the first vaccination to one year after the second dose vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days
The seroconversion rate, seropositivity rate 14 days after each dose vaccination
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days
The seroconversion rate, seropositive rate 28 days after the second dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days
GMT and GMI of neutralizing antibody and IgG 14 days after each dose vaccination
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days
GMT and GMI of neutralizing antibody and IgG 28 days after the second dose vaccination

Full Information

First Posted
October 1, 2020
Last Updated
August 3, 2022
Sponsor
Health Institutes of Turkey
search

1. Study Identification

Unique Protocol Identification Number
NCT04582344
Brief Title
Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)
Official Title
Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial For Evaluation of Efficacy and Safety of SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Institutes of Turkey

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 III clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental vaccine in healthy adults aged 18~59 Years.
Detailed Description
This study is a randomized, double-blinded, multi-center, placebo-controlled phase III clinical trial in adults aged 18~59 years. The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the experimental SARS-CoV-2 inactivated vaccine. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 13.000 subjects will be enrolled. Participant will be assigned to receive two doses of experimental vaccine or placebo on the schedule of day 0,14. It is planned that the study will be conducted with two separate cohorts. The first cohort will be healthcare workers in the high risk group (K-1) and the second cohort will be people at normal risk (K-2). After 2 doses of vaccination of 1300 volunteers are completed, safety data will be evaluated by the data safety monitoring board without breaking the blinding, and if there is no safety issue, the K2 cohort will continue to be vaccinated.1.300 volunteers, including 650 volunteers SARS-CoV-2 vaccine and placebo arms, will be included in the K-1 cohort. In the K-2 cohort (normal risk group for COVID-19), 7.650 volunteers were planned to be included in the SARS-CoV-2 vaccine group, and 3.500 volunteers in the placebo group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, SARS-CoV-2 Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
10214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SARS-COV-2 Vaccine
Arm Type
Experimental
Arm Description
600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart.
Intervention Type
Biological
Intervention Name(s)
CoronaVac
Intervention Description
Two doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart.
Primary Outcome Measure Information:
Title
Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19
Description
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19
Time Frame
2 weeks after the second dose of vaccination
Secondary Outcome Measure Information:
Title
Protection Indexes of One Vaccine Dose For Symptomatic COVID-19
Description
The protection rate of, at least, one dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19 Two weeks after the last dose vaccination.
Time Frame
2 weeks after the second dose of vaccination
Title
Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death
Description
The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against rates of hospitalization, disease severity/and death two weeks after the second dose of vaccination
Time Frame
2 weeks after the second dose of vaccination
Title
Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection
Description
The protection rate of a two dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed SARS-CoV-2 infection two weeks after the second dose of vaccination
Time Frame
2 weeks after the second dose of vaccination
Title
Safety indexes of adverse reactions in 28 days
Description
The incidence of adverse reactions from the day of first vaccination to 28 days after the second dose of vaccination.
Time Frame
28 days after the second dose of vaccination
Title
Safety indexes of adverse reactions in 7 days
Description
The incidence of adverse reactions within 7 days after each dose of vaccination
Time Frame
7 days after each dose of vaccination
Title
Safety indexes of serious adverse events in 1 year
Description
The incidence of SAEs from the first vaccination to one year after the second dose vaccination
Time Frame
1 year after second dose of vaccination
Title
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 14 days
Description
The seroconversion rate, seropositivity rate 14 days after each dose vaccination
Time Frame
14 days after each dose vaccination
Title
Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days
Description
The seroconversion rate, seropositive rate 28 days after the second dose vaccination
Time Frame
28 days after the second dose vaccination
Title
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 14 days
Description
GMT and GMI of neutralizing antibody and IgG 14 days after each dose vaccination
Time Frame
14 days after each dose vaccination
Title
Immunogenicity parameters (GMT and GMI of neutralizing antibody and IgG) in 28 days
Description
GMT and GMI of neutralizing antibody and IgG 28 days after the second dose vaccination
Time Frame
28 days after the second dose 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: 18-59 years of age (including 18 and 59 years of ages), For only K1 cohort, health care workers such as medical doctor, nurse, ward boy, cleaner, hospital technician, administrative personnel who work in any department of a hospital. Signed informed consent Exclusion Criteria: Previously PCR positive for COVID-19 IgG or IgM is positive For females: Pregnancy (confirmed by positive beta-hCG test), breastfeeding or intent to engage in sexual relations with reproductive intent without use of birth control methods in the three months following vaccination Known allergy to components of the study vaccine or control Use of immunosuppressant therapy regimens within the six months prior to enrollment in the study or planned use within the two years following enrollment. Immunosuppressant therapy regimens include: antineoplastic chemotherapy, radiation therapy and immunosuppressants to induce transplant tolerance, among others Use of immunosuppressive doses of corticosteroids within the three months prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids within the three months following enrollment in the study. Immunosuppressive doses of corticosteroids will be considered the equivalent prednisone 20 mg/day for adults, for longer than one week. Continued use of topical or nasal corticosteroids is not considered an immunosuppressant History of asplenia History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture Any alcohol or drug abuse over the 12 months prior to enrollment in the study that has caused medical, professional or family problems, indicated by clinical history Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate Participation in another clinical trial with an investigational product in the six months prior to enrollment in the study or planned participation in another clinical trial within the two years following enrollment Received live attenuated virus vaccine 14 days prior to enrollment in the study Inactivated vaccine or sub unit vaccine 7 days prior to enrollment in the study Fever (oral temperature >37.2℃, axillary temperature will not be accepted) within the past 24 hours Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol. Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Akova, Prof.
Organizational Affiliation
Faculty Member
Official's Role
Principal Investigator
Facility Information:
Facility Name
T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
City
Ankara
State/Province
Turkey Region
ZIP/Postal Code
06800
Country
Turkey
Facility Name
T.R. Ministry of Health Ankara Provincial Health Directorate Ankara Training and Research Hospital, Infectious Diseases
City
Ankara
State/Province
Turkey Region
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
City
Ankara
State/Province
Turkey Region
Country
Turkey
Facility Name
Çukurova University Faculty of Medicine, Department of Infectious Diseases
City
Adana
Country
Turkey
Facility Name
Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology
City
Ankara
Country
Turkey
Facility Name
T.C Ministry of Health Ankara Provincial Health Directorate Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Ankara
Country
Turkey
Facility Name
Akdeniz University Faculty of Medicine, Department of Infectious Diseases
City
Antalya
Country
Turkey
Facility Name
Bursa Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
City
Bursa
Country
Turkey
Facility Name
Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
City
Diyarbakır
Country
Turkey
Facility Name
Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
City
Gaziantep
Country
Turkey
Facility Name
Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology
City
Istanbul
Country
Turkey
Facility Name
Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
City
Istanbul
Country
Turkey
Facility Name
Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine
City
Istanbul
Country
Turkey
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
City
Istanbul
Country
Turkey
Facility Name
T.R. Ministry of Health Istanbul Provincial Health Directorate Marmara Univesity Istanbul Pendik Education and Research Hospital
City
Istanbul
Country
Turkey
Facility Name
T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic
City
Istanbul
Country
Turkey
Facility Name
T.R. Ministry of Health Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Istanbul
Country
Turkey
Facility Name
University of Health Sciences İstanbul Ümraniye Training and Research Hospital
City
Istanbul
Country
Turkey
Facility Name
Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases
City
İzmir
Country
Turkey
Facility Name
Republic Of Turkey Ministry Of Health Izmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital
City
İzmir
Country
Turkey
Facility Name
T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
City
İzmir
Country
Turkey
Facility Name
T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
City
Kayseri
Country
Turkey
Facility Name
Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
City
Kocaeli
Country
Turkey
Facility Name
Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
City
Malatya
Country
Turkey
Facility Name
Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology
City
Trabzon
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32376603
Citation
Gao Q, Bao L, Mao H, Wang L, Xu K, Yang M, Li Y, Zhu L, Wang N, Lv Z, Gao H, Ge X, Kan B, Hu Y, Liu J, Cai F, Jiang D, Yin Y, Qin C, Li J, Gong X, Lou X, Shi W, Wu D, Zhang H, Zhu L, Deng W, Li Y, Lu J, Li C, Wang X, Yin W, Zhang Y, Qin C. Development of an inactivated vaccine candidate for SARS-CoV-2. Science. 2020 Jul 3;369(6499):77-81. doi: 10.1126/science.abc1932. Epub 2020 May 6.
Results Reference
background
PubMed Identifier
35464483
Citation
Luan N, Li T, Wang Y, Cao H, Yin X, Lin K, Liu C. Th2-Oriented Immune Serum After SARS-CoV-2 Vaccination Does Not Enhance Infection In Vitro. Front Immunol. 2022 Apr 8;13:882856. doi: 10.3389/fimmu.2022.882856. eCollection 2022.
Results Reference
derived
PubMed Identifier
34246358
Citation
Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, Yilmaz A, Ozkul A, Gur H, Unal S; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8. Erratum In: Lancet. 2022 Jan 29;399(10323):436.
Results Reference
derived
PubMed Identifier
33849629
Citation
Akova M, Unal S. A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Apr 13;22(1):276. doi: 10.1186/s13063-021-05180-1.
Results Reference
derived

Learn more about this trial

Clinical Trial For SARS-CoV-2 Vaccine (COVID-19)

We'll reach out to this number within 24 hrs