This is a randomized, double-blinded, and positive-controlled Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the immunogenicity of using the high (1200SU) or medium (600SU) dose of CoronaVac® as the booster dose.
This is a randomized, double-blinded, and positive-controlled phaseⅡb clinical trial of 640 participants aged 18 years and above, who have completed 2 doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty) as the primary vaccination. Participants will be enrolled and randomly assigned into two arms at a ratio of 1:1 to receive a booster dose of medium-dose (600SU) or high-dose (1200SU) COVID-19 Vaccine. For those who were vaccinated with CoronaVac®, the booster dose will be given 3-8 months after their second dose. For those who were vaccinated with Comirnaty, the booster dose will be given 6-8 months after their second dose. Each participant will be collected 5.0 ml blood sample before vaccination and 14 days,3 months and 6 months after booster immunization.Immunogenicity assessments will be determined by neutralizing antibodies in all participants.In addition,all participants will be monitored for immediate reactions (within 30 minutes) after the booster dose vaccination, adverse events of special interest (AESIs) and serious adverse events (SAEs) for 12 months after booster dose inoculation. In addition, all participants in will be monitored for local and systemic solicited adverse events (AEs) within 7 days and the unsolicited AEs within 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
640
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Hacettepe University Faculty of Medicine, Department of Internal Diseases / Infectious Diseases and Clinical Microbiology Unit
Ankara, Turkey (Türkiye)
Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases
Ankara, Turkey (Türkiye)
Immunogenicity index-GMT of neutralizing antibodies
GMT of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
Time frame: 14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-Seropositivity rate of neutralizing antibodies
Seropositivity rate of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
Time frame: 14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-GMI of neutralizing antibodies
GMI of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
Time frame: 14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-The seropositivity rate of neutralizing antibody
Seropositivity rate of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Time frame: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Immunogenicity index-GMT of neutralizing antibody
GMT of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Time frame: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following the booster dose vaccination
Time frame: 7 days following the booster dose vaccination
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Safety index-Occurrence, intensity, duration, and relationship of unsolicited AEs
Occurrence, intensity, duration, and relationship of unsolicited AEs for 28 days post booster vaccination
Time frame: 28 days post booster vaccination
Safety index-Occurrence and relationship of SAEs
Occurrence and relationship of SAEs (from the booster dose to 12 months post booster vaccination)
Time frame: From the booster dose to 12 months post booster vaccination
Safety index-Occurrence and relationship of AESI
Occurrence and relationship of AESI (from the booster dose to 12 months post booster vaccination)
Time frame: From the booster dose to 12 months post booster vaccination