Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
NCT Number: NCT04952727
This is a randomized, observer-blind, parallel-controlled study, for evaluation of safety and immunogenicity of sequential immunization of a recombinant COVID-19 vaccine (adenovirus type 5 vector) in Chinese healthy adults aged 60 and above after the priming vaccination of inactivated vaccine. 300 healthy subjects aged 60 and above will be recruited in this study. Of them, 200 subjects who have been vaccinated with two dose of inactive SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 3~6 months later. Other 100 subjects who have been vaccinated with one dose of inactivated SARS-CoV-2 vaccine will be recruited and randomized at a 1:1 ratio to receive a booster dose of inactivated SARS-CoV-2 vaccine or recombinant SARS-CoV-2 Ad5 vectored vaccine at 1~3 months later. 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 day 0 before the boosting with ad5 vectored vaccine and on day 14, 28 and month 6 after the boosting. Serum antibody levels, cellular immune responses and the subgroups or germlines of the specific B cells will be analyzed. Each subject will remain in this study for approximately 6 months.
Looking for future studies?
Notify Me60 year and older
All sexes
Interventional
Phase 4
Nanjing, Jiangsu, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
Other names: Ad5-nCoV
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Other names: CoronaVac
Time frame: Within 28 days after the booster dose
Incidence of adverse reactions within 28 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 14 days after the booster dose
Incidence of solicited adverse events (AE) within 14 days after the booster vaccination.
Time frame: within 28 days after the booster dose
Incidence of unsolicited adverse events (AE) within 28 days after vaccination.
Time frame: within 6 months after the booster dose
Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
GMT of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 14, day 28 and month 6after the booster vaccination.
Time frame: on day 28 and month 6 after the last dose of vaccination
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 6 after the booster dose.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Fold increase of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the last dose of vaccination
Fold increase of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Proportion of the participants with at least a four-fold increase of the binding antibodies against SARS-CoV-2 S and N protein on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Proportion of the participants with at least a four-fold increase of neutralizing antibodies against live SARS-CoV-2virus, as compared to baseline, at Day 14, Day 28 and Month 6 after the booster vaccination.
Time frame: on day 14 after the booster vaccination
Specific T cell responses on day 14 after the booster vaccination detected by ELISPOT.
Time frame: on day 14, day 28 and month 6 after the booster vaccination
Types of IgG binding to SARS-CoV-2 S protein on day 14, day 28 and month 6 after the booster vaccination.
Time frame: on day 28 after the booster vaccination
GMT of neutralizing antibodies against P.1 variants on day 28 after the booster vaccination.
Time frame: on day 28 after the booster vaccination
GMT of neutralizing antibodies against 501Y.V2 variants on day 28 after the booster vaccination.
Jiangsu Province Centers for Disease Control and Prevention
Network
Safety and Immunogenicity of Sequential Immunization of Inactivated COVID-19 Vaccine and Recombinant COVID-19 Vaccine (Ad5 Vector) inChinese Healthy Adults Aged 60 and Above: a Randomized, Observer-blind,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.
Published trials that share one or more normalized conditions with this study.
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT07722000
COVID-19, Chronic Disease
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT04371432
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial Details