COVID-19 Vaccine Induced Adaptive Immune Responses

Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04729374

Enrollment

200

Registered

2021-01-28

Start date

2021-01-27

Completion date

2023-12-31

Last updated

2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2, Vaccine

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum	2 years
Concentration of serum anti-SARS-CoV-2 binding antibody	2 years
Rate of anti-SARS-CoV-2 T cell response	2 years
The rate of SARS-CoV-2 infection	2 years

Secondary

Measure	Time frame
Rate of anti-SARS-CoV-2 B cell response	2 years

Countries

China

Contacts

Primary ContactChao Wu, M.D., Ph.D

dr.wu@nju.edu.cn+8613809022921

Backup ContactYuxin Chen, Ph.D

yuxin_chen2015@163.com+8617714413628

Outcome results