A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine

COVID-19 Clinical Trial

Official title:

A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493917
• Other study ID #: KY2021-923
• Status: Recruiting
• Start date: November 3, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the COVID-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. Subjects received a third dose of the COVID-19 vaccine will be enrolled in the study and followed up for 1 year at baseline (day 0) before vaccine injection, 28 days after injection, 90 days, 270 days after injection. On the 365th day, blood samples were collected for the detection of anti-SARS-CoV-2 antibodies and other related indicators to evaluate the immune protection effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years old, gender is not limited;
• Subjects who completed the second dose of COVID-19 inactivated vaccine for more than 6 months and received the third dose of the same vaccine

Exclusion Criteria:

• allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
• those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
• Receiving other research drugs within 3 months ;participating in other research vaccines Or subjects in clinical trials of research drugs;
• other conditions that the investigator judges are not suitable for this clinical trial;

Related Conditions & MeSH terms

• COVID-19
• Vaccine Reaction

Intervention

Biological:
• an inactivated SARS-CoV-2 vaccine named BBIBP-CorV
Completed 2 doses of an inactivated SARS-CoV-2 vaccine more than 6 months ago and received a third dose of the vaccine

Locations

Country	Name	City	State
China	Infectious department of Huashan Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titers (GMTs)	Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies	Day 28±3 after the third dose of vaccine injection
Secondary	Geometric mean titers (GMTs)	Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies	Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
Secondary	IgG	Serum SAS-CoV-2 IgG	Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection