This is a randomized, open-label, parallel-controlled study to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) after priming with an inactivated SARS-CoV-2 vaccine in adults at 18 years of age or above. 420 healthy subjects aged over or equal to 18 years whom have received two doses of inactivated SARS-CoV-2 vaccines within the last 3\~9 months, will be recruited in this study. Eligible participants will be randomized at a 1:1:1 ratio to receive a booster dose of inactive SARS-CoV-2 vaccine or a low dose of aerosolized Ad5-nCoV or a high dose of aerosolized Ad5-nCoV. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on the day 0 before and day 7, 14, 28 and month 3, 6, and 12 after the booster vaccination. Each subject will remain in this study for approximately 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
423
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
This vaccine is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.1 ml / dose, contains 1×10\^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
This vaccine is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.2 ml / dose, contains 2×10\^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
Donghai County Center for Diseases Control and Prevention
Lianyungang, Jiangsu, China
Incidence of adverse reactions within 14 days after the booster dose.
Incidence of adverse reactions within 14 days after vaccination.
Time frame: Within 14 days the booster dose
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.
Time frame: On day 14 after the booster dose
Incidence of adverse events within 0-28 days after the booster dose.
Incidence of adverse events (AE) within 0-28 days after the booster vaccination.
Time frame: within 28 days after the booster dose.
Incidence of serious adverse events (SAE) till the 12 months after the booster dose.
Incidence of serious adverse events (SAE) till the 12 months after booster vaccination.
Time frame: within 12 months after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.
Time frame: on day 7 and 28 after the boost vaccination.
Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster vaccination.
Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14 after the booster vaccination.
Time frame: on day 14 after the last dose of vaccination.
GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
Time frame: at month 3, 6, and 12 after the boost vaccination.
GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD on day 7, day 14, day 28 after the booster dose.
GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 7, day 14, day 28 after the booster vaccination.
Time frame: on day 7, day 14, day 28 after the booster vaccination.
GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD at month 3, 6, and 12 after the booster dose.
GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA at month 3, 6, and 12 after the booster vaccination.
Time frame: at month 3, 6, and 12 after the booster vaccination.
The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.
The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.
Time frame: on day 7 and 14 after the booster vaccination.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.