Donghai County Center for Diseases Control and Prevention
Lianyungang, Jiangsu, China
NCT Number: NCT05043259
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Lianyungang, Jiangsu, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within 14 days the booster dose
Incidence of adverse reactions within 14 days after vaccination.
Time frame: 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: within 28 days after the booster dose.
Incidence of adverse events (AE) within 0-28 days after the booster vaccination.
Time frame: within 12 months after the booster dose.
Incidence of serious adverse events (SAE) till the 12 months after booster vaccination.
Time frame: on day 7 and 28 after the boost vaccination.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.
Time frame: on day 14 after the last dose of 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: at month 3, 6, and 12 after the boost 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.
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 S and N protein measured by ELISA on day 7, day 14, day 28 after the booster vaccination.
Time frame: at month 3, 6, and 12 after the booster vaccination.
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: 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.
Jiangsu Province Centers for Disease Control and Prevention
Network
Immunogenicity and Safety of the Heterologous Prime-boost Immunization with an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Two-dose Priming with an Inactivated SARS-CoV-2 Vaccine in Adults At 18 Years of Age or Above: a Randomised, Open-label, Parallel-controlled Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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