HealthyNCT04972591
Follow-up Study of Population Vaccinated With COVID-19 Vaccine
An observational study of Healthy, run by Qin Ning at 1 site in China.
Trial summary
A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2021to 30 Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All population who has been vaccinated or are prepared to get vaccinated.
Who may be able to join
- Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies.
Who cannot join
- People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before.
- People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.)
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.)
- People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control.
- Pregnant woman
- Juvenile
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Qin Ning, PHD,MD, +8602783662391, qning@vip.sina.com
Xiaoping Luo, PHD,MD, xpluo888@sina.com
About this study
A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.
Read the detailed description
From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.
- Conditions
- Healthy
- Keywords
- COVID-19, Vaccination, Anti-body
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CHB Group | Patients with CHB | |
| Compared Group | Healthy people |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms and signs
symptoms and signs after vaccination will be collected
Measured: 6months
antibody levels
antibody levels will be collected
Measured: 6months
laboratory findings
Clinical laboratory examination were obtained during follow-up.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start15 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Yichang Central People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Xiangya Hospital of Central South University, Shiyan Renmin Hospital, The second Hospital of JingZhou, Yunnan Provincial Infectious Disease Hospital, WUHAN NO.7 HOSPITAL, Shanxi Bethune Hospital
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972591
- Sponsor's protocol ID
- TJ20210623
- Status last verified
- Mar 2021
- First submitted
- 21 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Population Vaccinated With COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT04972591
- Acronym / sponsor ID
- TJ20210623
- Conditions
- Healthy
- Keywords
- COVID-19, Vaccination, Anti-body
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Yichang Central People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Xiangya Hospital of Central South University, Shiyan Renmin Hospital, The second Hospital of JingZhou, Yunnan Provincial Infectious Disease Hospital, WUHAN NO.7 HOSPITAL, Shanxi Bethune Hospital
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 22 Jul 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.
A multi-centered clinical follow-up study to investigate the long-term dynamic of COVID-19 antibody level after vaccination.
Detailed description
From December 2019, coronavirus disease 2019 (COVID-19), caused by a β-coronavirus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread across the globe. As of July 6, 2021, more than 180 million confirmed cases and around 4 million deaths have been reported globally. Till now, many treatment methods has gradually formed a consensus. At the same time, several domestic vaccines have been offered to the public for free inoculation in our country. However, due to the urgent form of the epidemic, the short vaccine development cycle and heavy tasks, there is no clear conclusion on the long-term changes in antibody levels after vaccination.Therefore, we plan to carry out a multi-center prospective observational trial to better understand the dynamic changes of the antibody levels in patients after vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHB Group | – | –Patients with CHB |
| Compared Group | – | –Healthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All population who has been vaccinated or are prepared to get vaccinated.
Key inclusion criteria (1 listed)
- Adult (18 years old or elder) who prepare or have been vaccinated against COVID-19, and has not participated in similar clinical studies.
Key exclusion criteria (6 listed)
- People who are allergic to any active ingredient of the vaccine, any inactive ingredient which was used in the production process, or those who have been allergic to the same kind of vaccine before.
- People who have had severe allergic reaction to vaccine before (such as acute allergic reaction, vascular neuroedema, dyspnea, etc.)
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.)
- People who are feverish, or suffering from acute diseases, or suffering from acute episodes of chronic diseases, or with serious chronic diseases without control.
- Pregnant woman
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
symptoms and signs
Time frame: 6months
symptoms and signs after vaccination will be collected
antibody levels
Time frame: 6months
antibody levels will be collected
laboratory findings
Time frame: 6months
Clinical laboratory examination were obtained during follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
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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.
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 Healthy, run by Qin Ning 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 22 Jul 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 Qin Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptoms and signs (time frame: 6months). The study lists 3 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 22 Jul 2021.