Phase 3 Booster Vaccination Against COVID-19

February 28, 2024 updated by: Health Institutes of Turkey

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4340

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Çukurova University Faculty of Medicine, Department of Infectious Diseases
      • Ankara, Turkey, 06800
        • T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
      • Ankara, Turkey
        • Dışkapı SUAM Infectious Diseases and Clinical Microbiology
      • Antalya, Turkey
        • T.R. Ministry of Health Antalya Training And Research Hospital
      • Aydın, Turkey
        • T.R. Ministry of Health Aydın State Hospital
      • Balıkesir, Turkey
        • T.R. Ministry of Health Balıkesir Atatürk City Hospital
      • Bolu, Turkey
        • T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital
      • Bursa, Turkey
        • Uludağ University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
      • Bursa, Turkey
        • T.R. Ministry of Health Bursa City Hospital
      • Denizli, Turkey
        • T.R. Ministry of Health Denizli Acıpayam State Hospital
      • Elazığ, Turkey
        • T.R. Ministry of Health Elazığ Fethi Sekin City Hospital
      • Erzincan, Turkey
        • Erzincan Binali Yıldırım University Training and Research Hospital Traditional and Complementary Medicine Application Center - GETAT
      • Erzurum, Turkey
        • T.R. Ministry of Health Erzurum Regional Training and Research Hospital
      • Eskişehir, Turkey
        • Eskişehir Osmangazi University Eskişehir Osmangazi University Health, Application and Research Hospital
      • Eskişehir, Turkey
        • T.R. Ministry of Health Eskişehir City Hospital
      • Gaziantep, Turkey
        • T.R. Ministry of Health Dr. Ersin Arslan Training and Research Hospital
      • Istanbul, Turkey
        • Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
      • Istanbul, Turkey
        • T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital
      • Istanbul, Turkey
        • 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
        • T.R. Ministry of Health İstanbul Şişli Hamidiye Etfal Training and Research Hospital, Clinical Microbiology Clinic
      • Istanbul, Turkey
        • University of Health Sciences İstanbul Ümraniye Training and Research Hospital
      • Istanbul, Turkey, 34865
        • T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
      • Kahramanmaraş, Turkey
        • Kahramanmaraş Sütçü İmam University Infections Diseases
      • Kayseri, Turkey
        • Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
      • Kayseri, Turkey
        • T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
      • Kocaeli, Turkey
        • Kocaeli University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
      • Kocaeli, Turkey
        • T.R. Ministry of Health Kocaeli Health Sciences University Derince Training And Research Hospital
      • Konya, Turkey
        • T.R. Ministry of Health Konya City Hospital
      • Kütahya, Turkey
        • Kütahya University of Health Sciences, Infectious Diseases and Clinic
      • Kırıkkale, Turkey
        • Kırıkkale University Faculty of Medicine, Department of Internal Medicine
      • Malatya, Turkey
        • Malatya İnönü University Faculty of Medicine, Department of Infectious Diseases
      • Manisa, Turkey
        • T.R. Ministry of Health Manisa City Hospital
      • Mersin, Turkey
        • T.R. Ministry of Health Mersin City Training and Research Hospital
      • Tekirdağ, Turkey
        • T.R. Ministry of Health Tekirdağ Çorlu District State Hospital
      • Trabzon, Turkey
        • Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology
      • Van, Turkey
        • Van Yüzüncü Yıl University Hospital, Faculty of Medicine, Infectious Diseases and Clinical Microbiology
      • İzmir, Turkey
        • T.R. Ministry of Health İzmir Provincial Health Directorate Health Sciences University Dr Suat Seren Chest Diseases And Chest Surgery Training And Research Hospital
      • İzmir, Turkey
        • T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
      • İzmir, Turkey
        • T.R. Ministry of Health İzmir Katip Çelebi University Atatürk Training and Research Hospital, Infectious Diseases Clinic
      • Şanlıurfa, Turkey
        • Şanlıurfa Harran University Hospital
    • Turkey Region
      • Ankara, Turkey Region, Turkey, 06800
        • T.R. Ministry of Health Ankara Keçiören Sanatorium Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CoronaVac
Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
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.
Experimental: Turkovac
Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protection rates of Turkovac and CoronaVac vaccines against symptomatic COVID-19
Time Frame: 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.
At least 14 days after booster vaccination dose
To Evaluate the SARS-CoV2 anti-spike protein immunoglobulin G
Time Frame: 28 days after booster vaccination dose
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
Time Frame: 28 days after booster vaccination dose
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
Time Frame: 28 days after booster vaccination dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AE)
Time Frame: On days 7 and 14 days after vaccination
To evaluate the safety of booster dose vaccines by determining the incidence of adverse reactions.
On days 7 and 14 days after vaccination
Incidence of Serious Adverse Events (SAE)
Time Frame: 168 days after vaccination
To evaluate the safety of booster dose vaccines by determining the incidence of serious adverse reactions.
168 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Institutes of Turkey

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

February 5, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inaktif_Rapel_Faz 3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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