SARS-CoV-2NCT04729374
COVID-19 Vaccine Induced Adaptive Immune Responses
An observational study of SARS-CoV-2 and Vaccine, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Vaccine, COVID-19
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals to be injected with COVID-19 vaccine
Who may be able to join
- Healthy and aged between 18 to 59 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yuxin Chen
Chao Wu
About this study
Official title: Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
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.
- Conditions
- SARS-CoV-2, Vaccine, COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum
Measured: 2 years
Concentration of serum anti-SARS-CoV-2 binding antibody
Measured: 2 years
Rate of anti-SARS-CoV-2 T cell response
Measured: 2 years
The rate of SARS-CoV-2 infection
Measured: 2 years
Secondary outcomes (1)
Rate of anti-SARS-CoV-2 B cell response
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start27 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yuxin Chen, Principal investigator, Nanjing Drum Tower Hospital, Nanjing University Medical SchoolHan Shen, Principal investigator, Nanjing Drum Tower Hospital, Nanjing University Medical SchoolRui Huang, Principal investigator, Nanjing Drum Tower Hospital, Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729374
- Sponsor's protocol ID
- NJGLVAC-001
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longidutinal, Dynamic Analysis of COVID-19 Vaccine Induced Adaptive Immune Responses
- ClinicalTrials.gov ID
- NCT04729374
- Acronym / sponsor ID
- NJGLVAC-001
- Conditions
- SARS-CoV-2, Vaccine, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals to be injected with COVID-19 vaccine
Key inclusion criteria (1 listed)
- Healthy and aged between 18 to 59 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum
Time frame: 2 years
Concentration of serum anti-SARS-CoV-2 binding antibody
Time frame: 2 years
Rate of anti-SARS-CoV-2 T cell response
Time frame: 2 years
The rate of SARS-CoV-2 infection
Time frame: 2 years
1 secondary outcome
Rate of anti-SARS-CoV-2 B cell response
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxin Chen principal investigator
Nanjing Drum Tower Hospital, Nanjing University Medical School
Han Shen principal investigator
Nanjing Drum Tower Hospital, Nanjing University Medical School
Rui Huang principal investigator
Nanjing Drum Tower Hospital, Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 and Vaccine, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Wu, M.D., Ph.D (+8613809022921, dr.wu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of anti-SARS-CoV-2 neutralizing antibody in serum (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.