COVID-19NCT05072496
Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine
An observational study of COVID-19, run by Centers for Disease Control and Prevention, China at 1 site in China.
Trial summary
The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2020to 27 Sep 2021
- 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: The healthy people aged between 18 and 59, and have not been infected with COVID-19, have not been vaccinated with COVID-19 vaccine, and agree to collect blood samples.
Who may be able to join
- Working at the CDC
- Between the ages of 18 and 59
- Healthy
- Not vaccinated with COVID-19 vaccine
- Agreed to take a blood sample
Who cannot join
- who cannot take the COVID-19 vaccine due to some personal reasons
- history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
- high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
- axillary temperature of more than 37·0℃
- history of allergy to any vaccine component.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Cohort Study on Antibody Persistence and Immune Memory After Two Doses of Inactivated COVID-19 Vaccine in 150 People
The study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement, and be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.
- Conditions
- COVID-19
- Keywords
- Inactivated vaccine, cohort study, Antibody persistence, cellular immunity
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Durability of humoral and cellular immune responses
The humoral immunogenicity outcomes include the RBD-specific IgG titers and neutralising antibodies amounts at 1, 3, 6, and 12 months after the second shot. The positive cutoff for RBD-specific IgG antibodies was defined as the sample cutoff (S/CO) value ≥1.0. Seroconversion of neutralising antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titre increase. The positive cutoff of the titre for neutralising antibodies was 1/4.
The cellular immune response outcomes measured by ICS assays across the blood collection time points.the percentage of RBD-specific CD4+ CD8+ memory T cells after vaccination.
Measured: 12 months after fully vaccination
Secondary outcomes (3)
The dynamic variation of the level of antibody
RBD-IgG and neutralizing antibody level after vaccination at 1,3 and 6 ,12months vaccination.
Measured: 1，3，6 , 12 month
Cytokine secretion by peripheral blood mononuclear cells
To study the cytokine production of PBMC after stimulation with RBD after vaccination at 1,3,6 and 12 months vaccination,for examples IL-2,IL-5,IFN and GrB.
Measured: 1,3,6,12 month
TCM and TEM amount varies at different time points
The dynamic variation of specificity TCM and TEM after vaccination at 1,3,6 and 12 months vaccination.
Measured: 1,3,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start20 Jul 2020
- Primary completion30 Aug 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072496
- Sponsor's protocol ID
- BJCDCWJ202101
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Antibody Persistence and Immune Memory After Two Doses of Inactivated COVID-19 Vaccine in 150 People
- ClinicalTrials.gov ID
- NCT05072496
- Acronym / sponsor ID
- BJCDCWJ202101
- Conditions
- COVID-19
- Keywords
- Inactivated vaccine, cohort study, Antibody persistence, cellular immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 11 Oct 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 study describe 1 year durability of humoral and cellular immune responses in 150 individuals who received COVID-19 inactivated vaccine. all participants were recruited aged between 18 and 59 years old. Every participant was familiarized with the aim of the study and asked to sign an informed consent agreement, and be required blood sampling at the day 0 of first dose vaccine and 1 month, 3 months, 6 months and 12 months after fully vaccination separately. From every sample, 10 ml, 10 ml, and 5 ml were dispensed in three vacuum blood collection tubes. Peripheral blood lymphocytes cell (PBMC) were isolated with the two 10 ml samples contained heparin to detect immune memory cells and cytokines. RBD-IgG and neutralizing antibody be detected by 5ml sample from separating gel vacuum tubes. every individual conducted a detailed analysis comparing neutralizing antibody, TEM, TCM , and report on the cellular and humoral immunity 1 year after accept COVID-19 vaccine.
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
- The healthy people aged between 18 and 59, and have not been infected with COVID-19, have not been vaccinated with COVID-19 vaccine, and agree to collect blood samples.
Key inclusion criteria (5 listed)
- Working at the CDC
- Between the ages of 18 and 59
- Healthy
- Not vaccinated with COVID-19 vaccine
- Agreed to take a blood sample
Key exclusion criteria (5 listed)
- who cannot take the COVID-19 vaccine due to some personal reasons
- history of SARS-CoV, SARS-CoV-2, or Middle East respiratory syndrome infection
- high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with SARS-CoV-2)
- axillary temperature of more than 37·0℃
- history of 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
Durability of humoral and cellular immune responses
Time frame: 12 months after fully vaccination
The humoral immunogenicity outcomes include the RBD-specific IgG titers and neutralising antibodies amounts at 1, 3, 6, and 12 months after the second shot. The positive cutoff for RBD-specific IgG antibodies was defined as the sample cutoff (S/CO) value ≥1.0. Seroconversion of neutralising antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titre increase. The positive cutoff of the titre for neutralising antibodies was 1/4. The cellular immune response outcomes measured by ICS assays across the blood collection time points.the percentage of RBD-specific CD4+ CD8+ memory T cells after vaccination.
3 secondary outcomes
The dynamic variation of the level of antibody
Time frame: 1，3，6 , 12 month
Cytokine secretion by peripheral blood mononuclear cells
Time frame: 1,3,6,12 month
TCM and TEM amount varies at different time points
Time frame: 1,3,6,12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19, run by Centers for Disease Control and Prevention, China 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Durability of humoral and cellular immune responses (time frame: 12 months after fully vaccination). 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 11 Oct 2021.