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

• ClinicalTrials.gov Identifier: NCT04582344
• Recruitment Status: Active, not recruiting
• First Posted: October 9, 2020
• Last Update Posted: August 4, 2022
• Sponsor: Health Institutes of Turkey
• Information provided by (Responsible Party): Health Institutes of Turkey

Tracking Information

• First Submitted Date: October 1, 2020
• First Posted Date: October 9, 2020
• Last Update Posted Date: August 4, 2022
• Actual Study Start Date: September 14, 2020
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 8, 2020)

Protection Indexes of Two Vaccine Doses For Symptomatic COVID-19 [ Time Frame: 2 weeks after the second dose of vaccination ]

The protection rate of a two-dose of SARS-CoV-2 (Vero Cell) vaccine against RT-PCR confirmed symptomatic COVID-19

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 8, 2020)

• Protection Indexes of One Vaccine Dose For Symptomatic COVID-19 [ Time Frame: 2 weeks after the second dose of vaccination ]
  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 [ Time Frame: 2 weeks after the second dose of vaccination ]
  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 [ Time Frame: 2 weeks after the second dose of vaccination ]
  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 [ Time Frame: 28 days after the second dose of vaccination ]
  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 [ Time Frame: 7 days after each dose of vaccination ]
  The incidence of adverse reactions within 7 days after each dose of vaccination
• Safety indexes of serious adverse events in 1 year [ Time Frame: 1 year after second dose of vaccination ]
  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 [ Time Frame: 14 days after each dose vaccination ]
  The seroconversion rate, seropositivity rate 14 days after each dose vaccination
• Immunogenicity parameters (seroconversion rate, seropositivity rate) in 28 days [ Time Frame: 28 days after the second dose vaccination ]
  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 [ Time Frame: 14 days after each dose vaccination ]
  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 [ Time Frame: 28 days after the second dose vaccination ]
  GMT and GMI of neutralizing antibody and IgG 28 days after the second dose vaccination

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Double-Blind

Primary Purpose: Prevention

• Condition: COVID-19

Intervention

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

Study Arms

• Experimental: SARS-COV-2 Vaccine
  600 SU of SARS-CoV-2 virus antigen, intramuscular injection, two doses given 14 days apart.
  Intervention: Biological: CoronaVac
• Placebo Comparator: Placebo
  Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, intramuscular injection, two doses given 14 days apart.
  Intervention: Biological: Placebo

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: May 10, 2022): 10214
• Original Estimated Enrollment (submitted: October 8, 2020): 13000
• Estimated Study Completion Date: August 31, 2022
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04582344
• Other Study ID Numbers: 9026-ASI
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Health Institutes of Turkey
• Original Responsible Party: Same as current
• Current Study Sponsor: Health Institutes of Turkey
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Murat Akova, Prof.; Faculty Member

• PRS Account: Health Institutes of Turkey
• Verification Date: August 2022