Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

4800 China Booster study Link: A randomized, double-blinded, placebo-controlled phase II clinical study to evaluate the intradermal injection of different doses of COVID-19 DNA vaccine and the booster vaccination of inactivated vaccines in healthy adult and elderly subjects

https://www.chictr.org.cn/hvshowproject.aspx?ID=96769

Registration number:
ChiCTR2000040146
Date of Last Refreshed on:
2021/8/4 23:41:55

second segment: Primary objectives: 1.To evaluate the humoral immunogenicity in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. 2.To evaluate the safety of the healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. Secondary objective: To evaluate the cellular immunogenicity in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine.

Exploratory objective: 1.To evaluate the immunogenicity persistence in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine. 2.To evaluate the neutralizing response against COVID-19 variants in healthy subjects over 18 years old after boosted with the COVID-19 DNA vaccine or inactivated vaccine.

Outcome:
GMT of specific antibody against S protein of SARS-CoV-2

GMT of neutralizing antibody against S protein of SARS-CoV-2

Measure time point of outcome:
30 days after the second dose of vaccine

Group:
The second segment: A1 group
Sample size:
????:
??????????(Vero??)0.5mL
??????:
Intervention:
COVID-19 Inactivated Vaccine (CoronaVac) 0.5mL
Intervention code:
??:
????:A2?
???:
50
Group:
The second segment: A2 group
Sample size:
????:
??????????(Vero??)0.5mL
??????:
Intervention:
COVID-19 Inactivated Vaccine (CoronaVac) 0.5mL
Intervention code:
??:
????:A3?
???:
25
Group:
The second segment: A3 group
Sample size:
????:
???? pGX9501 1.0 mg
??????:
Intervention:
pGX9501 1.0 mg
Intervention code:
??:
????:A4?
???:
25
Group:
The second segment: A4 group
Sample size:
????:
???? pGX9501 2.0 mg
??????