Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

A randomized, open-label and positive-control phase I/II clinical trial to explore the safety and immunogenicity of the COVID-19 DNA injected as boost dose to subjects already immunized with COVID-19 inactivated vaccines
Study execute time: 11/30/21 To 7/31/22

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.

ChiCTR2100049744 Scientific Title:
A phase I/II clinical trial investigating heterologous prime-boost COVID-19 vaccination in healthy volunteers aged over 18 years old

Applicant's institution:
Advaccine Biopharmaceuticals Suzhou. Pty. Ltd

Primary sponsor:
Sichuan Provincial Center for Disease Control and Prevention

Institution
hospital:
Neijiang City Center for Disease Control and Prevention

Study design: Parallel

4. The subjects in Groups B1, B3, B5 and C1 have received two doses of the COVID-19 inactivated vaccine within 3 months (+15 days) before participating in the screening of this study.

5. The subjects in Groups B2, B4, B6 and C2 have received two doses of the COVID-19 inactivated vaccine within 6 months (+15 days) before participating in the screening of this study.

Measure time point of outcome:3, 14, 30 days after the third dose => Very short trial

http://www.chictr.org.cn/hvshowproject.aspx?id=96875