Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine

NCT ID: NCT05072496

Last Updated: 2021-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-09-27

Brief Summary

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The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement, and be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Working at the CDC
* Between the ages of 18 and 59
* Healthy
* Not vaccinated with COVID-19 vaccine
* Agreed to take a blood sample

Exclusion Criteria

* who cannot take the COVID-19 vaccine due to some personal reasons
* history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
* high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
* axillary temperature of more than 37·0℃
* history of allergy to any vaccine component.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wu Jiang

Director of Institute for Vaccines and Immunization

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Center for Disease Control and Prevention

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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BJCDCWJ202101

Identifier Type: -

Identifier Source: org_study_id

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