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

NCT04582344 | Completed Phase 3 DMC

• 1 other identifier: 9026-ASI
• Study Type: interventional
• Target: 10,214
• Locations: 1 country
• Sites: 25

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.

Conditions

COVID-19

Keywords

COVID-19, SARS-CoV-2 Vaccine

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks after the second dose of vaccination

Secondary Outcomes (10)

• Protection Indexes of One Vaccine Dose For Symptomatic COVID-19

  2 weeks after the second dose of vaccination

• Protection Indexes of Second Vaccine Dose For Hospitalization, Disease Severity/and Death

  2 weeks after the second dose of vaccination

• Protection Indexes of Two Vaccine Doses For SARS-CoV-2 infection

  2 weeks after the second dose of vaccination

• Safety indexes of adverse reactions in 28 days

  28 days after the second dose of vaccination

• Safety indexes of adverse reactions in 7 days

  7 days after each dose of vaccination

Study Arms (2)

SARS-COV-2 Vaccine

EXPERIMENTAL

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

Biological: CoronaVac

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

CoronaVac 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

SARS-COV-2 Vaccine

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (25)

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

Ankara, Turkey Region, 06800, Turkey (Türkiye)

Location

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

Ankara, Turkey Region, 06800, Turkey (Türkiye)

Location

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

Ankara, Turkey Region, Turkey (Türkiye)

Location

Çukurova University Faculty of Medicine, Department of Infectious Diseases

Adana, Turkey (Türkiye)

Location

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

Ankara, Turkey (Türkiye)

Location

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)

Location

Akdeniz University Faculty of Medicine, Department of Infectious Diseases

Antalya, Turkey (Türkiye)

Location

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

Bursa, Turkey (Türkiye)

Location

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

Diyarbakır, Turkey (Türkiye)

Location

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

Gaziantep, Turkey (Türkiye)

Location

Acıbadem Atakent Hospital, Infectious Diseases and Clinical Microbiology

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

Istanbul Medipol University Faculty of Medicine, Department of Internal Medicine

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences İstanbul Ümraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

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

Izmir, Turkey (Türkiye)

Location

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)

Location

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

Izmir, Turkey (Türkiye)

Location

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

Kayseri, Turkey (Türkiye)

Location

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

Kocaeli, Turkey (Türkiye)

Location

Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases

Malatya, Turkey (Türkiye)

Location

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

Trabzon, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32376603 BACKGROUND

• 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.

  PMID: 35464483 DERIVED

• 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.

  PMID: 34246358 DERIVED

• 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.

  PMID: 33849629 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Murat Akova, Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 9, 2020
• Study Start: September 14, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 27, 2022
• Last Updated: May 24, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (25)