Clinical trial NCT04979949: Booster Vaccination Against COVID-19
Official title: Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Sars-CoV-2 Infection
Keywords: COVID-19
SARS-CoV-2 Vaccine
Booster
Efficacy
Immunogenicity
Safety
Lead sponsor: Health Institutes of Turkey
Sponsor class: OTHER_GOV
First posted: 2021-07-28
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: 7 days after vaccination
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: 168 days after vaccination
Secondary outcomes:
measure: Neutralizing antibody and anti-spike protein immunoglobulin G
timeFrame: On days 0, 28 and 84
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Internal Medicine Clinic
city: Istanbul
country: Turkey
facility: Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic
city: Istanbul
country: Turkey
facility: T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
city: Istanbul
country: Turkey
facility: Ümraniye Training and Research Hospital Infectious Diseases
Study officials:
affiliation: Faculty Member
name: Ahmet Omma, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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