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

• Conditions: Vaccine Reaction; COVID-19

• Registration Number: NCT05493917
• Lead Sponsor: Huashan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-03
• Status Verified: 2022-08
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-07
• Last Update Submitted: 2022-08-07
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric mean titers (GMTs)	Day 28±3 after the third dose of vaccine injection	Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies

Secondary Outcome Measures

Name	Time	Method
Geometric mean titers (GMTs)	Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection	Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies
IgG	Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection	Serum SAS-CoV-2 IgG

Trial Locations

Locations (1)

Infectious department of Huashan Hospital, Fudan University; 🇨🇳 Shanghai, China