COVID-19 Vaccine Induced Adaptive Immune Responses

NCT ID: NCT04729374

Last Updated: 2021-02-05

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2023-12-31

Brief Summary

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The coronavirus disease 2019 (COVID-19) caused by the infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),resulting in more than 82 million confirmed cases and caused around 1.8 million deaths, as of 2 January 2021. The ongoing pandemic still poses unprecedented global threat to public health system worldwide. On December 31, 2020, the joint prevention and control agency of China Council announced that Sinopharm SARS-CoV-2 inactivated vaccine had been conditionally approved by National Medical Products Administration, and the protection rate was 79.34%. So far, more than 198 vaccines were currently in preclinical or clinical development. The investigators aimed to initiate an observational cohort of healthy individuals injected with SARS-CoV-2 Vaccine, which will perform a longitudinal, comprehensive analysis of the SARS-CoV-2 vaccine Induced adaptive immune responses.

Detailed Description

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Conditions

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SARS-CoV-2 Vaccine COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Healthy and aged between 18 to 59 years

Exclusion Criteria

* High-risk epidemiology history within 14 days before enrollment
* SARS-CoV-2 specific IgG or IgM positive in serum
* Positive PCR test for SARS-CoV-2 from pharyngeal or anal swab samples
* Axillary temperature of more than 37·0°C
* Known allergy to any vaccine component
* Thyroid disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Chao Wu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuxin Chen

Role: PRINCIPAL_INVESTIGATOR

Nanjing Drum Tower Hospital, Nanjing University Medical School

Han Shen

Role: PRINCIPAL_INVESTIGATOR

Nanjing Drum Tower Hospital, Nanjing University Medical School

Rui Huang

Role: PRINCIPAL_INVESTIGATOR

Nanjing Drum Tower Hospital, Nanjing University Medical School

Locations

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Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chao Wu, M.D., Ph.D

Role: CONTACT

+8613809022921

Yuxin Chen, Ph.D

Role: CONTACT

+8617714413628

Facility Contacts

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Yuxin Chen

Role: primary

Other Identifiers

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NJGLVAC-001

Identifier Type: -

Identifier Source: org_study_id

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