Phase 3 Booster Vaccination Against SARS-CoV-2

Sponsor
Health Institutes of Turkey (Other)
Overall Status
Recruiting
CT.gov ID
NCT05077176
Collaborator
(none)
7,400
Enrollment
41
Locations
2
Arms
11.9
Anticipated Duration (Months)
180.5
Patients Per Site
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: CoronaVac
  • Biological: Turkovac
Phase 3

Detailed Description

The inactivated Booster Phase 3 study aims to determine the efficacy, safety, and immunogenicity of inactivated COVID-19 vaccines in subjects with a minimum of 90 days and a maximum of 270 days after the second dose of CoronaVac vaccine. For the booster dose, subjects will be assigned open-label according to their preference for 2 different arms.

The booster dose vaccine arms are as follows:
  • CoronaVac

  • Turkovac

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7400 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination (CoronaVac or TURKOVAC) Against SARS-CoV-2Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination (CoronaVac or TURKOVAC) Against SARS-CoV-2
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Open Label, Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2
Actual Study Start Date :
Oct 8, 2021
Anticipated Primary Completion Date :
Apr 5, 2022
Anticipated Study Completion Date :
Oct 5, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: CoronaVac

600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection.

Biological: CoronaVac
One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Active Comparator: Turkovac

600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection.

Biological: Turkovac
One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Outcome Measures

Primary Outcome Measures

  1. Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19 [At least 14 days after booster vaccination dose]

    Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19 confirmed by RT-PCR at least 14 days after booster vaccination dose.

Secondary Outcome Measures

  1. Incidence of Adverse Events (AE) and Serious Adverse Events (SAE) [7 days and 168 days after vaccination]

    To evaluate the safety of booster dose vaccines by determining the incidence of adverse reactions and serious adverse events.

  2. To Evaluate the Immunogenicity [On days 0, 28, 48, 84 and 168 after vaccination]

    To evaluate the immunogenicity of booster dose vaccines

  3. To determine the seropositivity rate of SARS-CoV2 specific binding antibody [After booster dose 0, 28 (all subjects), 48, 84 and 168 days (50% of subjects)]

    Determination of SARS-CoV2 specific binding antibody seropositivity rate after booster dose 0, 28 (all subjects), 48, 84 and 168 days (50% of subjects)

  4. Evaluation of SARS-CoV2 Neutralizing Antibodies [After booster dose 0, 28 (all subjects), 48, 84 and 168 (50% of subjects)]

    Evaluation of SARS-CoV2 neutralizing antibodies by neutralization test after booster dose 0, 28 (all subjects), 48, 84 and 168 (50% of subjects)

  5. T-Cell Evaluation [On days 0, 28, 48, 84 and 168 after vaccination]

    T cell evaluation in 30 - 45 subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:

Inclusion Criteria:
  1. Subjects willing and able to give signed informed consent to participate in study,

  2. Healthy male or female aged 18 - 60 years (including both groups),

  3. Subjects who were vaccinated with CoronaVac for 2 doses and who had a minimum of 90 days and a maximum of 270 days after the second dose,

  4. Subjects with 4-6 weeks between CoronaVac 1st and 2nd dose vaccines,

  5. Female subjects of childbearing potential should be willing to ensure that they or their partner use effective birth control methods continuously from 1 month before and up to 3 months after vaccination,

  6. In the opinion of the investigator, subjects capable and willing to comply with all study requirements,

  7. Subjects are willing to agree to abstain from donating blood during the study.

Subjects meeting any of the following criteria will not be included in the study:
Exclusion Criteria:
  1. Administration of any vaccine (registered or investigational) other than study intervention within 30 days before and after each study vaccine (one week for authorized seasonal flu vaccine or pneumococcal vaccine),

  2. Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine),

  3. Known history of SARS-CoV-2 infection,

  4. Pregnant and puerperant subjects (subjects who become pregnant 2 months after vaccination will continue to study),

  5. Subjects with fever (above 37,8°C) at the time of vaccination and/or up to 72 hours before (After the acute condition has resolved, the subject can be screened again),

  6. Administration of immunoglobulins and/or any blood product within 3 months prior to vaccination,

  7. Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; recurrent severe infections and use of immunosuppressants (less than ≤14 days) in the last 6 months, excluding topical steroids or short-term oral steroids,

  8. Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines,

  9. Any history of anaphylaxis,

  10. Current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and cervical carcinoma in situ),

  11. History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture,

  12. Continued use of anticoagulants such as coumarins and related anticoagulants (i.e. warfarin) or new oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban),

  13. Cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2),

  14. Suspected or known current alcohol or drug addiction,

  15. Any other significant disease, disorder or finding that could significantly increase the subject's risk for participation in the study, affect the subject's ability to participate in the study, or impair the interpretation of study data; severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are permitted),

  16. History of active or previous autoimmune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (Bell's palsy will not be an exclusion criterion),

  17. Subjects with severe renal impairment or liver failure,

  18. Subjects who will undergo scheduled elective surgery during the study,

  19. Subjects with a life expectancy of less than 6 months,

  20. Subject who participated in another clinical trial study involving an investigational product in the past 12 weeks,

  21. In case of clinical necessity, a COVID-19 PCR (polymerase chain reaction) test will be requested from the subjects, and subjects who are positive will be excluded from the study,

  22. Acute respiratory disease (moderate or severe illness with or without fever). (Subjects may be screened again after acute condition has resolved),

  23. Insufficient level of Turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research HospitalAnkaraTurkey RegionTurkey06800
2Çukurova University Faculty of Medicine, Department of Infectious DiseasesAdanaTurkey
3T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology ClinicAnkaraTurkey06800
4Dışkapı SUAM Infectious Diseases and Clinical MicrobiologyAnkaraTurkey
5T.R. Ministry of Health Antalya Training And Research HospitalAntalyaTurkey
6T.R. Ministry of Health Aydın State HospitalAydınTurkey
7T.R. Ministry of Health Balıkesir Atatürk City HospitalBalıkesirTurkey
8T.R. Ministry of Health Abant Izzet Baysal University Training and Research HospitalBoluTurkey
9T.R. Ministry of Health Bursa City HospitalBursaTurkey
10Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical MicrobiologyBursaTurkey
11T.R. Ministry of Health Denizli Acıpayam State HospitalDenizliTurkey
12T.R. Ministry of Health Elazığ Fethi Sekin City HospitalElazığTurkey
13Erzincan Binali Yıldırım University Training and Research Hospital Traditional and Complementary Medicine Application Center - GETATErzincanTurkey
14T.R. Ministry of Health Erzurum Regional Training and Research HospitalErzurumTurkey
15Eskişehir Osmangazi University Eskişehir Osmangazi University Health, Application and Research HospitalEskişehirTurkey
16T.R. Ministry of Health Eskişehir City HospitalEskişehirTurkey
17T.R. Ministry of Health Dr. Ersin Arslan Training and Research HospitalGaziantepTurkey
18T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious DiseasesIstanbulTurkey34865
19Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical MicrobiologyIstanbulTurkey
20T.R. Ministry of Health Başakşehir Çam ve Sakura City HospitalIstanbulTurkey
21T.R. Ministry of Health Istanbul Provincial Health Directorate Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Prof. Dr. Feriha Öz Emergency Hospital)IstanbulTurkey
22T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology ClinicIstanbulTurkey
23University of Health Sciences İstanbul Ümraniye Training and Research HospitalIstanbulTurkey
24T.R. Ministry of Health İzmir Katip Çelebi University Atatürk Training and Research Hospital, Infectious Diseases ClinicİzmirTurkey
25T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research HospitalİzmirTurkey
26T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious DiseasesİzmirTurkey
27Kahramanmaraş Sütçü İmam University Infections DiseasesKahramanmaraşTurkey
28Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical MicrobiologyKayseriTurkey
29T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology DepartmentKayseriTurkey
30Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical MicrobiologyKocaeliTurkey
31T.R. Ministry of Health Kocaeli Health Sciences University Derince Training And Research HospitalKocaeliTurkey
32T.R. Ministry of Health Konya City HospitalKonyaTurkey
33Kütahya University of Health Sciences, Infectious Diseases and ClinicKütahyaTurkey
34Kırıkkale University Faculty of Medicine, Department of Internal MedicineKırıkkaleTurkey
35Malatya İnönü University Faculty of Medicine, Department of Infectious DiseasesMalatyaTurkey
36T.R. Ministry of Health Manisa City HospitalManisaTurkey
37T.R. Ministry of Health Mersin City Training and Research HospitalMersinTurkey
38T.R. Ministry of Health Tekirdağ Çorlu District State HospitalTekirdağTurkey
39Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical MicrobiologyTrabzonTurkey
40Van Yüzüncü Yıl University Hospital, Faculty of Medicine, Infectious Diseases and Clinical MicrobiologyVanTurkey
41Şanlıurfa Harran University HospitalŞanlıurfaTurkey

Sponsors and Collaborators

  • Health Institutes of Turkey

Investigators

  • Principal Investigator: Bedia Dinç, Assoc. Prof., Faculty Member

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Health Institutes of Turkey
ClinicalTrials.gov Identifier:
NCT05077176
Other Study ID Numbers:
  • Inaktif_Rapel_Faz 3
First Posted:
Oct 14, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Health Institutes of Turkey
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2021