COVID-19 Vaccine Induced Adaptive Immune Responses
Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedStudy Start
First participant enrolled
January 27, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 5, 2021
February 1, 2021
2.9 years
January 25, 2021
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Rate of anti-SARS-CoV-2 B cell response
2 years
Eligibility Criteria
Healthy individuals to be injected with COVID-19 vaccine
You may qualify if:
- Healthy and aged between 18 to 59 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Biospecimen
blood (serum, plasma, and DNA)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuxin Chen
Nanjing Drum Tower Hospital, Nanjing University Medical School
- PRINCIPAL INVESTIGATOR
Han Shen
Nanjing Drum Tower Hospital, Nanjing University Medical School
- PRINCIPAL INVESTIGATOR
Rui Huang
Nanjing Drum Tower Hospital, Nanjing University Medical School
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 25, 2021
First Posted
January 28, 2021
Study Start
January 27, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 5, 2021
Record last verified: 2021-02