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Booster Vaccination Against SARS-CoV-2

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ClinicalTrials.gov Identifier: NCT04979949
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Health Institutes of Turkey

Study Description
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Brief Summary:
A booster dose of vaccine (Eru-CoV-Vac or CoronaVac) 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.

Condition or disease Intervention/treatment Phase
COVID-19 Sars-CoV-2 Infection Biological: CoronaVac Phase 2

Detailed Description:

To determine the safety and immunogenicity of booster doses of vaccine against SARS-CoV2 after a minimum of 90 days and a maximum of 270 days after the 2nd dose of a homologous 2 dose primary regimen.

It is planned to recruit 111 subjects for 2 vaccines (Eru-CoV-Vac or CoronaVac). There will be a total of 222 subjects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-Blind, Randomized, Controlled, Multi-Center Phase 2 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2 (Hybrid COV-Rapel TR)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-Blind
Primary Purpose: Prevention
Official Title: Double-Blind, Randomized, Controlled, Multi-Center Phase 2 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : July 12, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: CoronaVac
600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection. 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.
 Biological: CoronaVac
Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28
Experimental: ERU-CoV-VAC
600 Subunit of SARS-CoV-2 virus antigen, intramuscular injection. 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.
 Biological: CoronaVac
Two doses at 28-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (vaccine contains 600 subunit of SARS-CoV-2 virus antigen) vaccine at the schedule of day 0, 28


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse reactions [ Time Frame: 7 days after vaccination ]
    Incidence of adverse reactions within 7 days of vaccination in all subjects

  2. Incidence of Serious Adverse Events (CAO) [ Time Frame: 168 days after vaccination ]
    Incidence of Serious Adverse Events (CAO) in all subjects 168 days after vaccination


Secondary Outcome Measures :
  1. Neutralizing antibody and anti-spike protein immunoglobulin G [ Time Frame: On days 0, 28 and 84 ]
    Amount of SARS-CoV2 anti-spike protein immunoglobulin G and SARS-CoV2 neutralizing antibody amount


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Healthy male or female aged 18 - 60 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 may have a controlled or moderate comorbidity
  • 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
  • Subjects agreed to comply with all study requirements
  • Subjects are willing to share their medical history with their physician and allow access to all medical records when relevant to study procedures
  • Subjects are willing to agree to abstain from donating blood during the study

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  • Receipt 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)
  • Positive for COVID-19 after primary vaccination
  • Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine)
  • Subjects who were pregnant at the time of enrollment or who plan to become pregnant within the first 3 months following vaccination and who are breastfeeding
  • Subjects with fever (above 38°C) at the time of vaccination and/or up to 72 hours before
  • 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 (eg 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 (ie warfarin) or new oral anticoagulants (ie 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 (eg 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
  • Known history of SARS-CoV-2 infection
  • Acute respiratory disease (moderate or severe illness with or without fever) (Subjects may be screened again after acute condition has resolved)
  • Fever (oral temperature > 37.8°C) (Subjects can be enroll again after acute condition improves)
  • Insufficient level of Turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04979949


Contacts
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Contact: Ahmet Omma, Assoc. Prof. +90 (312) 552 60 00 ahmetomma@hotmail.com
Contact: İhsan Ateş, Assoc. Prof. dr.ihsanates@hotmail.com

Locations
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Turkey
Ankara City Hospital Internal Medicine Clinic Recruiting
Ankara, Turkey
Contact: Ahmet Omma, Assoc. Prof.    +90 (312) 552 60 00    ahmetomma@hotmail.com   
Principal Investigator: Ahmet Omma, Assoc. Prof.         
Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic Recruiting
Istanbul, Turkey
Contact: Fatma Yılmaz Karadağ, Assoc. Prof.    +90 (0216) 606 33 00    dr_fatma@hotmail.com   
Principal Investigator: Fatma Yılmaz Karadağ, Assoc. Prof.         
T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases Recruiting
Istanbul, Turkey
Contact: Ayşe Batırel, Prof.    +90 (0216) 458 30 00    aysebatirel@yahoo.com   
Principal Investigator: Ayşe Batırel, Prof.         
Ümraniye Training and Research Hospital Infectious Diseases Recruiting
Istanbul, Turkey
Contact: Mehtap Aydın, Assoc. Prof.    +90 (0216) 632 18 18    mehtapaydin10@gmail.com   
Principal Investigator: Mehtap Aydın, Assoc. Prof.         
Sponsors and Collaborators
Health Institutes of Turkey
Investigators
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Principal Investigator: Ahmet Omma, Assoc. Prof. Faculty Member
More Information
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Publications:

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Responsible Party: Health Institutes of Turkey
ClinicalTrials.gov Identifier: NCT04979949    
Other Study ID Numbers: Hybrid COV-Rapel TR
First Posted: July 28, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Health Institutes of Turkey:
COVID-19
SARS-CoV-2 Vaccine
Booster
 Efficacy
Immunogenicity
Safety