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

NCT05493917 | Unknown

• 1 other identifier: KY2021-923
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vaccine Reaction

Keywords

inactive vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Geometric mean titers (GMTs)

  Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection

• IgG

  Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection

Interventions

an inactivated SARS-CoV-2 vaccine named BBIBP-CorV BIOLOGICAL

Completed 2 doses of an inactivated SARS-CoV-2 vaccine more than 6 months ago and received a third dose of the vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruit and screen subjects who have completed 2 doses of the new coronavirus vaccine for more than 6 months and voluntarily receive a third dose of the vaccine

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Infectious department of Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 9, 2022
• Study Start: November 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)