Clinical trial NCT05077176: Phase 3 Booster Vaccination Against COVID-19
Official title: Open Label, Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Sars-CoV-2 Infection
Keywords: COVID-19
SARS-CoV-2 Vaccine
Booster
Efficacy
Immunogenicity
Safety
Lead sponsor: Health Institutes of Turkey
Sponsor class: OTHER_GOV
First posted: 2021-10-14
Enrollment: 4340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination (CoronaVac or TURKOVAC) Against SARS-CoV-2
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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 - 59 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 minimum 28 days and maximum 42 days 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, Male subjects of potential to have children 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.

Primary outcomes:
measure: Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19
timeFrame: At least 14 days after booster vaccination dose
measure: To Evaluate the SARS-CoV2 anti-spike protein immunoglobulin G
timeFrame: 28 days after booster vaccination dose
measure: Evaluation of SARS-CoV2 Neutralizing Antibodies
timeFrame: 28 days after booster vaccination dose
measure: T-Cell Evaluation
timeFrame: 28 days after booster vaccination dose
Secondary outcomes:
measure: Incidence of Adverse Events (AE)
timeFrame: On days 7 and 14 days after vaccination
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: 168 days after vaccination
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
state: Turkey Region
city: Adana
country: Turkey
facility: Çukurova University Faculty of Medicine, Department of Infectious Diseases
city: Ankara
country: Turkey
facility: T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
city: Ankara
country: Turkey
facility: Dışkapı SUAM Infectious Diseases and Clinical Microbiology
city: Antalya
country: Turkey
facility: T.R. Ministry of Health Antalya Training And Research Hospital
city: Aydın
country: Turkey
facility: T.R. Ministry of Health Aydın State Hospital
city: Balıkesir
country: Turkey
facility: T.R. Ministry of Health Balıkesir Atatürk City Hospital
city: Bolu
country: Turkey
facility: T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital
city: Bursa
country: Turkey
facility: T.R. Ministry of Health Bursa City Hospital
city: Bursa
country: Turkey
facility: Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
city: Denizli
country: Turkey
facility: T.R. Ministry of Health Denizli Acıpayam State Hospital
city: Elazığ
country: Turkey
facility: T.R. Ministry of Health Elazığ Fethi Sekin City Hospital
city: Erzincan
country: Turkey
facility: Erzincan Binali Yıldırım University Training and Research Hospital Traditional and Complementary Medicine Application Center - GETAT
city: Erzurum
country: Turkey
facility: T.R. Ministry of Health Erzurum Regional Training and Research Hospital
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University Eskişehir Osmangazi University Health, Application and Research Hospital
city: Eskişehir
country: Turkey
facility: T.R. Ministry of Health Eskişehir City Hospital
city: Gaziantep
country: Turkey
facility: T.R. Ministry of Health Dr. Ersin Arslan Training and Research Hospital
city: Istanbul
country: Turkey
facility: T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
city: Istanbul
country: Turkey
facility: Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
city: Istanbul
country: Turkey
facility: T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital
city: Istanbul
country: Turkey
facility: T.R. Ministry of Health Istanbul Provincial Health Directorate Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Prof. Dr. Feriha Öz Emergency Hospital)
city: Istanbul
country: Turkey
facility: T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic
city: Istanbul
country: Turkey
facility: University of Health Sciences İstanbul Ümraniye Training and Research Hospital
city: İzmir
country: Turkey
facility: T.R. Ministry of Health İzmir Katip Çelebi University Atatürk Training and Research Hospital, Infectious Diseases Clinic
city: İzmir
country: Turkey
facility: T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital
city: İzmir
country: Turkey
facility: T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sütçü İmam University Infections Diseases
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
city: Kayseri
country: Turkey
facility: T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
city: Kocaeli
country: Turkey
facility: Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
city: Kocaeli
country: Turkey
facility: T.R. Ministry of Health Kocaeli Health Sciences University Derince Training And Research Hospital
city: Konya
country: Turkey
facility: T.R. Ministry of Health Konya City Hospital
city: Kütahya
country: Turkey
facility: Kütahya University of Health Sciences, Infectious Diseases and Clinic
city: Kırıkkale
country: Turkey
facility: Kırıkkale University Faculty of Medicine, Department of Internal Medicine
city: Malatya
country: Turkey
facility: Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
city: Manisa
country: Turkey
facility: T.R. Ministry of Health Manisa City Hospital
city: Mersin
country: Turkey
facility: T.R. Ministry of Health Mersin City Training and Research Hospital
city: Tekirdağ
country: Turkey
facility: T.R. Ministry of Health Tekirdağ Çorlu District State Hospital
city: Trabzon
country: Turkey
facility: Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University Hospital, Faculty of Medicine, Infectious Diseases and Clinical Microbiology
city: Şanlıurfa
country: Turkey
facility: Şanlıurfa Harran University Hospital
Study officials:
affiliation: Faculty Member
name: Bedia Dinç, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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