Study Results
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Basic Information
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COMPLETED
PHASE3
4340 participants
INTERVENTIONAL
2021-10-08
2024-02-05
Brief Summary
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Detailed Description
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The booster dose vaccine arms are as follows:
* CoronaVac
* Turkovac
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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CoronaVac
Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
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.
Turkovac
Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
59 Years
ALL
Yes
Sponsors
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Health Institutes of Turkey
OTHER_GOV
Responsible Party
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Principal Investigators
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Bedia Dinç, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Faculty Member
Locations
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T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital
Ankara, Turkey Region, Turkey (Türkiye)
Çukurova University Faculty of Medicine, Department of Infectious Diseases
Adana, , Turkey (Türkiye)
T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
Ankara, , Turkey (Türkiye)
Dışkapı SUAM Infectious Diseases and Clinical Microbiology
Ankara, , Turkey (Türkiye)
T.R. Ministry of Health Antalya Training And Research Hospital
Antalya, , Turkey (Türkiye)
T.R. Ministry of Health Aydın State Hospital
Aydin, , Turkey (Türkiye)
T.R. Ministry of Health Balıkesir Atatürk City Hospital
Balıkesir, , Turkey (Türkiye)
T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital
Bolu, , Turkey (Türkiye)
T.R. Ministry of Health Bursa City Hospital
Bursa, , Turkey (Türkiye)
Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Bursa, , Turkey (Türkiye)
T.R. Ministry of Health Denizli Acıpayam State Hospital
Denizli, , Turkey (Türkiye)
T.R. Ministry of Health Elazığ Fethi Sekin City Hospital
Elâzığ, , Turkey (Türkiye)
Erzincan Binali Yıldırım University Training and Research Hospital Traditional and Complementary Medicine Application Center - GETAT
Erzincan, , Turkey (Türkiye)
T.R. Ministry of Health Erzurum Regional Training and Research Hospital
Erzurum, , Turkey (Türkiye)
Eskişehir Osmangazi University Eskişehir Osmangazi University Health, Application and Research Hospital
Eskişehir, , Turkey (Türkiye)
T.R. Ministry of Health Eskişehir City Hospital
Eskişehir, , Turkey (Türkiye)
T.R. Ministry of Health Dr. Ersin Arslan Training and Research Hospital
Gaziantep, , Turkey (Türkiye)
T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
Istanbul, , Turkey (Türkiye)
Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
Istanbul, , Turkey (Türkiye)
T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital
Istanbul, , Turkey (Türkiye)
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)
Istanbul, , Turkey (Türkiye)
T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic
Istanbul, , Turkey (Türkiye)
University of Health Sciences İstanbul Ümraniye Training and Research Hospital
Istanbul, , Turkey (Türkiye)
T.R. Ministry of Health İzmir Katip Çelebi University Atatürk Training and Research Hospital, Infectious Diseases Clinic
Izmir, , Turkey (Türkiye)
T.R. Ministry of Health İzmir 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)
Kahramanmaraş Sütçü İmam University Infections Diseases
Kahramanmaraş, , Turkey (Türkiye)
Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Kayseri, , 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)
T.R. Ministry of Health Kocaeli Health Sciences University Derince Training And Research Hospital
Kocaeli, , Turkey (Türkiye)
T.R. Ministry of Health Konya City Hospital
Konya, , Turkey (Türkiye)
Kütahya University of Health Sciences, Infectious Diseases and Clinic
Kütahya, , Turkey (Türkiye)
Kırıkkale University Faculty of Medicine, Department of Internal Medicine
Kırıkkale, , Turkey (Türkiye)
Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
Malatya, , Turkey (Türkiye)
T.R. Ministry of Health Manisa City Hospital
Manisa, , Turkey (Türkiye)
T.R. Ministry of Health Mersin City Training and Research Hospital
Mersin, , Turkey (Türkiye)
Şanlıurfa Harran University Hospital
Sanliurfa, , Turkey (Türkiye)
T.R. Ministry of Health Tekirdağ Çorlu District State Hospital
Tekirdağ, , Turkey (Türkiye)
Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology
Trabzon, , Turkey (Türkiye)
Van Yüzüncü Yıl University Hospital, Faculty of Medicine, Infectious Diseases and Clinical Microbiology
Van, , Turkey (Türkiye)
Countries
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References
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Kumar A, Singh R, Kaur J, Pandey S, Sharma V, Thakur L, Sati S, Mani S, Asthana S, Sharma TK, Chaudhuri S, Bhattacharyya S, Kumar N. Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. 2021 Mar 30;11:596201. doi: 10.3389/fcimb.2021.596201. eCollection 2021.
Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.
Doria-Rose N, Suthar MS, Makowski M, O'Connell S, McDermott AB, Flach B, Ledgerwood JE, Mascola JR, Graham BS, Lin BC, O'Dell S, Schmidt SD, Widge AT, Edara VV, Anderson EJ, Lai L, Floyd K, Rouphael NG, Zarnitsyna V, Roberts PC, Makhene M, Buchanan W, Luke CJ, Beigel JH, Jackson LA, Neuzil KM, Bennett H, Leav B, Albert J, Kunwar P; mRNA-1273 Study Group. Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19. N Engl J Med. 2021 Jun 10;384(23):2259-2261. doi: 10.1056/NEJMc2103916. Epub 2021 Apr 6. No abstract available.
Wu K, Werner AP, Koch M, Choi A, Narayanan E, Stewart-Jones GBE, Colpitts T, Bennett H, Boyoglu-Barnum S, Shi W, Moliva JI, Sullivan NJ, Graham BS, Carfi A, Corbett KS, Seder RA, Edwards DK. Serum Neutralizing Activity Elicited by mRNA-1273 Vaccine. N Engl J Med. 2021 Apr 15;384(15):1468-1470. doi: 10.1056/NEJMc2102179. Epub 2021 Mar 17. No abstract available.
Madhi SA, Izu A, Pollard AJ. ChAdOx1 nCoV-19 Vaccine Efficacy against the B.1.351 Variant. Reply. N Engl J Med. 2021 Aug 5;385(6):571-572. doi: 10.1056/NEJMc2110093. Epub 2021 Jul 21. No abstract available.
Pavel STI, Yetiskin H, Aydin G, Holyavkin C, Uygut MA, Dursun ZB, Celik I, Cevik C, Ozdarendeli A. Isolation and characterization of severe acute respiratory syndrome coronavirus 2 in Turkey. PLoS One. 2020 Sep 16;15(9):e0238614. doi: 10.1371/journal.pone.0238614. eCollection 2020.
Other Identifiers
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Inaktif_Rapel_Faz 3
Identifier Type: -
Identifier Source: org_study_id
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