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Saturday, 02/05/2022 3:12:13 PM

Saturday, February 05, 2022 3:12:13 PM

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Latest update on China 4800/pGX9501 heterologous booster trial with new link
6 groups, 80 ppl each
Registration number:
ChiCTR2100049744
??????:
Date of Last Refreshed on:
2021/12/7 4:27:15

Study execute time:
?From2021-12-25?To 2022-07-25

Primary objective: ? To evaluate the humoral immunogenicity in healthy subjects (have received 2 doses of approved COVID19 inactivated vaccines previously) over 18 years old after boosted with the heterologous COVID-19 DNA vaccine. ? To evaluate the safety of the healthy subjects (have received 2 doses of approved COVID19 inactivated vaccines previously) over 18 years old after boosted with the heterologous COVID-19 DNA vaccine.

https://www.chictr.org.cn/hvshowproject.aspx?id=119337

Secondary objective: ? To evaluate the cellular immunogenicity in healthy subjects (have received 2 doses of approved COVID19 inactivated vaccine) over 18 years old after boosted with the heterologous COVID-19 DNA vaccine. Exploratory objective: ? To evaluate the long-term immune-response during follow-up in healthy subjects (have received 2 doses of approved COVID19 inactivated vaccine) over 18 years old after boosted with the heterologous COVID-19 DNA vaccine. ? To evaluate the neutralizing response against COVID-19 variants in healthy subjects (have received 2 doses of approved COVID19 inactivated vaccine) over 18 years old after boosted with the heterologous COVID-19 DNA vaccine.

Inclusion Criteria:

The subjects in Cohort A have received two doses of the COVID-19 inactivated vaccine (approved) within 3 months (+15 days) and have been dosed at a time interval of 21 (+10) days between the first and second vaccination before participating in the screening of this study.

The subjects in Cohort B have received two doses of the COVID-19 inactivated vaccine (approved) within 6 months (+15 days) and have been dosed at a time interval of 21 (+10) days between the first and second vaccination before participating in the screening of this study.
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