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

NCT ID: NCT04582344

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2022-07-27

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

SARS-COV-2 Vaccine

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

Group Type: EXPERIMENTAL

CoronaVac

Intervention Type: BIOLOGICAL

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

CoronaVac

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

Placebo

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Health Institutes of Turkey

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murat Akova, Prof.

Role: PRINCIPAL_INVESTIGATOR

Faculty Member

Locations

T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic

Ankara, Turkey Region, Turkey (Türkiye)

T.R. Ministry of Health Ankara Provincial Health Directorate Ankara Training and Research Hospital, Infectious Diseases

Ankara, Turkey Region, Turkey (Türkiye)

Ankara University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Ankara, Turkey Region, Turkey (Türkiye)

Çukurova University Faculty of Medicine, Department of Infectious Diseases

Adana, , Turkey (Türkiye)

Hacettepe University Faculty of Medicine Department of Infections Diseases and Clinical Microbiology

Ankara, , Turkey (Türkiye)

T.C Ministry of Health Ankara Provincial Health Directorate Health Sciences University Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital

Ankara, , Turkey (Türkiye)

Akdeniz University Faculty of Medicine, Department of Infectious Diseases

Antalya, , Turkey (Türkiye)

Bursa Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Bursa, , Turkey (Türkiye)

Dicle University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Diyarbakır, , Turkey (Türkiye)

Gaziantep University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Gaziantep, , Turkey (Türkiye)

Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology

Istanbul, , Turkey (Türkiye)

Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology

Istanbul, , Turkey (Türkiye)

Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine

Istanbul, , Turkey (Türkiye)

Istanbul University Istanbul Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Istanbul, , Turkey (Türkiye)

T.R. Ministry of Health Istanbul Provincial Health Directorate Marmara Univesity Istanbul Pendik Education and Research Hospital

Istanbul, , Turkey (Türkiye)

T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases Clinic

Istanbul, , Turkey (Türkiye)

T.R. Ministry of Health Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

University of Health Sciences İstanbul Ümraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Ege University Faculty of Medicine Hospital, Department of Infectious Diseasesaculty of Medicine Hospital, Department of Infectious Diseases

Izmir, , Turkey (Türkiye)

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

Izmir, , Turkey (Türkiye)

T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases

Izmir, , Turkey (Türkiye)

T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department

Kayseri, , Turkey (Türkiye)

Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

Kocaeli, , Turkey (Türkiye)

Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases

Malatya, , Turkey (Türkiye)

Karadeniz Technical University Medical Faculty Hospital, Department of Infectious Diseases and Clinical Microbiology

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32376603 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35464483 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34246358 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33849629 (View on PubMed)

Other Identifiers

9026-ASI

Identifier Type: -

Identifier Source: org_study_id