Phase 3 Booster Vaccination Against COVID-19

NCT05077176 | Completed Phase 3 DMC

• 1 other identifier: Inaktif_Rapel_Faz 3
• Study Type: interventional
• Target: 4,340
• Locations: 1 country
• Sites: 41

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.

Conditions

COVID-19; Sars-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 Vaccine; Booster; Efficacy; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (4)

• Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19

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

  At least 14 days after booster vaccination dose

• To Evaluate the SARS-CoV2 anti-spike protein immunoglobulin G

  The change in the amount of SARS-CoV2 anti-spike protein immunoglobulin G in the 28th day compared to the baseline is 2 times or more

  28 days after booster vaccination dose

• Evaluation of SARS-CoV2 Neutralizing Antibodies

  The change in the amount of SARS-CoV2 neutralizing antibodies in the 28th day compared to the baseline is 2 times or more

  28 days after booster vaccination dose

• T-Cell Evaluation

  IL-2, TNF-alpha and IFN-gamma levels in T cells changed by 2 times or more on day 28 compared to baseline for 35 - 40 subjects

  28 days after booster vaccination dose

Secondary Outcomes (2)

• Incidence of Adverse Events (AE)

  On days 7 and 14 days after vaccination

• Incidence of Serious Adverse Events (SAE)

  168 days after vaccination

Study Arms (2)

CoronaVac

ACTIVE COMPARATOR

Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.

Biological: CoronaVac

Turkovac

EXPERIMENTAL

Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.

Biological: Turkovac

Interventions

CoronaVac BIOLOGICAL

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.

CoronaVac

Turkovac BIOLOGICAL

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

Eligibility Criteria

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

You may qualify if:

• Subjects willing and able to give signed informed consent to participate in study,
• Healthy male or female aged 18 - 59 years (including both groups),
• 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,
• Subjects with minimum 28 days and maximum 42 days between CoronaVac 1st and 2nd dose vaccines,
• 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,
• In the opinion of the investigator, subjects capable and willing to comply with all study requirements,
• 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:

You may not qualify if:

• 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),
• Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine),
• Known history of SARS-CoV-2 infection,
• Pregnant and puerperant subjects (subjects who become pregnant 2 months after vaccination will continue to study),
• 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),
• Administration of immunoglobulins and/or any blood product within 3 months prior to vaccination,
• 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,
• Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines,
• Any history of anaphylaxis,
• Current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and cervical carcinoma in situ),
• 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,
• Continued use of anticoagulants such as coumarins and related anticoagulants (i.e. warfarin) or new oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban),
• Cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2),
• Suspected or known current alcohol or drug addiction,
• 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),

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (41)

T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Ankara, Turkey Region, 06800, Turkey (Türkiye)

Location

Çukurova University Faculty of Medicine, Department of Infectious Diseases

Adana, Turkey (Türkiye)

Location

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

Ankara, 06800, Turkey (Türkiye)

Location

Dışkapı SUAM Infectious Diseases and Clinical Microbiology

Ankara, Turkey (Türkiye)

Location

T.R. Ministry of Health Antalya Training And Research Hospital

Antalya, Turkey (Türkiye)

Location

T.R. Ministry of Health Aydın State Hospital

Aydin, Turkey (Türkiye)

Location

T.R. Ministry of Health Balıkesir Atatürk City Hospital

Balıkesir, Turkey (Türkiye)

Location

T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital

Bolu, Turkey (Türkiye)

Location

T.R. Ministry of Health Bursa City Hospital

Bursa, Turkey (Türkiye)

Location

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

Bursa, Turkey (Türkiye)

Location

T.R. Ministry of Health Denizli Acıpayam State Hospital

Denizli, Turkey (Türkiye)

Location

T.R. Ministry of Health Elazığ Fethi Sekin City Hospital

Elâzığ, Turkey (Türkiye)

Location

Erzincan Binali Yıldırım University Training and Research Hospital Traditional and Complementary Medicine Application Center - GETAT

Erzincan, Turkey (Türkiye)

Location

T.R. Ministry of Health Erzurum Regional Training and Research Hospital

Erzurum, Turkey (Türkiye)

Location

Eskişehir Osmangazi University Eskişehir Osmangazi University Health, Application and Research Hospital

Eskişehir, Turkey (Türkiye)

Location

T.R. Ministry of Health Eskişehir City Hospital

Eskişehir, Turkey (Türkiye)

Location

T.R. Ministry of Health Dr. Ersin Arslan Training and Research Hospital

Gaziantep, Turkey (Türkiye)

Location

T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases

Istanbul, 34865, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

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)

Location

T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic

Istanbul, Turkey (Türkiye)

Location

University of Health Sciences İstanbul Ümraniye Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

T.R. Ministry of Health İzmir Katip Çelebi University Atatürk Training and Research Hospital, Infectious Diseases Clinic

Izmir, Turkey (Türkiye)

Location

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)

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

Kahramanmaraş Sütçü İmam University Infections Diseases

Kahramanmaraş, Turkey (Türkiye)

Location

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

Kayseri, 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

T.R. Ministry of Health Kocaeli Health Sciences University Derince Training And Research Hospital

Kocaeli, Turkey (Türkiye)

Location

T.R. Ministry of Health Konya City Hospital

Konya, Turkey (Türkiye)

Location

Kütahya University of Health Sciences, Infectious Diseases and Clinic

Kütahya, Turkey (Türkiye)

Location

Kırıkkale University Faculty of Medicine, Department of Internal Medicine

Kırıkkale, Turkey (Türkiye)

Location

Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases

Malatya, Turkey (Türkiye)

Location

T.R. Ministry of Health Manisa City Hospital

Manisa, Turkey (Türkiye)

Location

T.R. Ministry of Health Mersin City Training and Research Hospital

Mersin, Turkey (Türkiye)

Location

Şanlıurfa Harran University Hospital

Sanliurfa, Turkey (Türkiye)

Location

T.R. Ministry of Health Tekirdağ Çorlu District State Hospital

Tekirdağ, Turkey (Türkiye)

Location

Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology

Trabzon, Turkey (Türkiye)

Location

Van Yüzüncü Yıl University Hospital, Faculty of Medicine, Infectious Diseases and Clinical Microbiology

Van, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33859951 BACKGROUND

• 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.

  PMID: 33408181 BACKGROUND

• 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.

  PMID: 33822494 BACKGROUND

• 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.

  PMID: 33730471 BACKGROUND

• 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.

  PMID: 34289271 BACKGROUND

• 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.

  PMID: 32936826 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine; TURKOVAC

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

• Bedia Dinç, Assoc. Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination (CoronaVac or TURKOVAC) Against SARS-CoV-2

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 14, 2021
• Study Start: October 8, 2021
• Primary Completion: May 10, 2023
• Study Completion: February 5, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

TU (41)