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COVID-19Phase 3NCT05077176

Phase 3 Booster Vaccination Against COVID-19

A Phase 3 study testing CoronaVac and Turkovac in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 41 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, Sars-CoV-2 Infection
What is being tested?
CoronaVac and Turkovac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,340 participants
Where
41 sitesTurkey (Türkiye)
Study dates
8 Oct 2021to 5 Feb 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:

Who cannot join

  • 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,
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  • 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),
  • 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),
  • Subjects with severe renal impairment or liver failure,
  • Subjects who will undergo scheduled elective surgery during the study,
  • Subjects with a life expectancy of less than 6 months,
  • Subject who participated in another clinical trial study involving an investigational product in the past 12 weeks,
  • 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,
  • Acute respiratory disease (moderate or severe illness with or without fever). (Subjects may be screened again after acute condition has resolved),
  • Insufficient level of Turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Turkey (Türkiye)41 sites

  • Çukurova University Faculty of Medicine, Department of Infectious Diseases

    Adana

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

    Ankara, Turkey Region, 06800

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

    Ankara, 06800

  • Dışkapı SUAM Infectious Diseases and Clinical Microbiology

    Ankara

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

    Antalya

  • T.R. Ministry of Health Aydın State Hospital

    Aydin

  • T.R. Ministry of Health Balıkesir Atatürk City Hospital

    Balıkesir

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

    Bolu

  • T.R. Ministry of Health Bursa City Hospital

    Bursa

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

    Bursa

  • T.R. Ministry of Health Denizli Acıpayam State Hospital

    Denizli

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

    Elâzığ

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

    Erzincan

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

    Erzurum

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

    Eskişehir

  • T.R. Ministry of Health Eskişehir City Hospital

    Eskişehir

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

    Gaziantep

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

    Istanbul, 34865

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

    Istanbul

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

    Istanbul

  • 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

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

    Istanbul

  • University of Health Sciences İstanbul Ümraniye Training and Research Hospital

    Istanbul

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

    Izmir

  • 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

  • T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases

    Izmir

  • Kahramanmaraş Sütçü İmam University Infections Diseases

    Kahramanmaraş

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

    Kayseri

  • T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department

    Kayseri

  • Kırıkkale University Faculty of Medicine, Department of Internal Medicine

    Kirikkale

  • Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology

    Kocaeli

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

    Kocaeli

  • T.R. Ministry of Health Konya City Hospital

    Konya

  • Kütahya University of Health Sciences, Infectious Diseases and Clinic

    Kütahya

  • Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases

    Malatya

  • T.R. Ministry of Health Manisa City Hospital

    Manisa

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

    Mersin

  • Şanlıurfa Harran University Hospital

    Sanliurfa

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

    Tekirdağ

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

    Trabzon

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

    Van

Other trials in Turkey (Türkiye)

About this study

Official title: Open Label, Multi-Center Phase 3 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2

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.

Read the 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
Being tested
CoronaVac, Turkovac
Keywords
COVID-19, SARS-CoV-2 Vaccine, Booster, Efficacy, Immunogenicity, Safety
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CoronaVacBiological

    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.

  • TurkovacBiological

    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.

Study groups in NCT05077176
Study groupRoleWhat they receive
CoronaVacActive comparatorInactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
Receives: Biological: CoronaVac
TurkovacExperimentalInactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
Receives: Biological: Turkovac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At least 14 days after booster vaccination dose

  2. 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

    Measured: 28 days after booster vaccination dose

  3. 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

    Measured: 28 days after booster vaccination dose

  4. 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

    Measured: 28 days after booster vaccination dose

Secondary outcomes (2)

  1. Incidence of Adverse Events (AE)

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

    Measured: On days 7 and 14 days after vaccination

  2. Incidence of Serious Adverse Events (SAE)

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

    Measured: 168 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start8 Oct 2021
  3. Primary completion10 May 2023
  4. Study completion5 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Multi-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)
Enrolment
4,340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077176
Sponsor's protocol ID
Inaktif_Rapel_Faz 3
Status last verified
Feb 2024
First submitted
13 Oct 2021
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33859951

  • 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.

    PubMed 33408181

  • 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.

    PubMed 33822494

  • 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.

    PubMed 33730471

  • 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.

    PubMed 34289271

  • 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.

    PubMed 32936826

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CoronaVac and Turkovac in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 41 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19 (time frame: At least 14 days after booster vaccination dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077176, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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