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Booster Vaccination Against COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04979949
Recruitment Status : Active, not recruiting
First Posted : July 28, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Health Institutes of Turkey

Tracking Information
First Submitted Date  ICMJE July 15, 2021
First Posted Date  ICMJE July 28, 2021
Last Update Posted Date November 30, 2021
Actual Study Start Date  ICMJE July 12, 2021
Estimated Primary Completion Date March 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2021)
  • Incidence of adverse reactions [ Time Frame: 7 days after vaccination ]
    Incidence of adverse reactions within 7 days of vaccination in all subjects
  • Incidence of Serious Adverse Events (SAE) [ Time Frame: 168 days after vaccination ]
    Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
  • Incidence of adverse reactions [ Time Frame: 7 days after vaccination ]
    Incidence of adverse reactions within 7 days of vaccination in all subjects
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2021)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Booster Vaccination Against COVID-19
Official Title  ICMJE Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2
Brief Summary A booster dose of vaccine (Turkovac 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.
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 (Turkovac and CoronaVac). There will be a total of 222 subjects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • COVID-19
  • Sars-CoV-2 Infection
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: CoronaVac
    Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
    Intervention: Biological: CoronaVac
  • Experimental: Turkovac
    Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
    Intervention: Biological: Turkovac
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 26, 2021)
222
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 11, 2022
Estimated Primary Completion Date March 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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)
  • 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 (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
  • 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 enrolled 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Participant eligibility is based on self-representation of gender identity.
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04979949
Other Study ID Numbers  ICMJE Hibrid COV-Rapel TR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Health Institutes of Turkey
Study Sponsor  ICMJE Health Institutes of Turkey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmet Omma, Assoc. Prof. Faculty Member
PRS Account Health Institutes of Turkey
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP