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CompletedNCT05072496Updated Oct 11, 2021

Study on Antibody Persistence and Immune Memory of Inactivated COVID-19 Vaccine

An observational study in COVID-19, sponsored by Centers for Disease Control and Prevention, China. Completed at 1 site in China. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Centers for Disease Control and Prevention, China · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 59 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 472 studies in COVID-19 with a site in China — 53 open to participants now, 75 under way, 8 of them phase 3. COVID-19 · China.

Enrollment
105th of 142
150 · median 388
Started
2020
with 122 others
Observational
142 of 472
24 open now
Registered
180th of 472
by date

Among the 472 studies in COVID-19 with a site in China, this one is the 105th largest by enrollment of the 142 observational ones that give a count, is one of 123 that started in 2020, is one of 142 observational ones, and was the 180th registered.

COVID-19

7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

53 of the 472 studies in COVID-19 with a site in China are open now. Recruiting first, the newest first:

48 more — sign in →

All 53 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.

This study: 18 Years to 59 Years · all sexes · healthy volunteers too.

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02

Study 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. 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.

03

Conditions studied

  • COVID-19

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Keywords

  • Inactivated vaccine
  • cohort study
  • Antibody persistence
  • cellular immunity
04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Working at the CDC
  • Between the ages of 18 and 59
  • Healthy
  • Not vaccinated with COVID-19 vaccine
  • Agreed to take a blood sample

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months after fully vaccination

Secondary outcomes

  1. The dynamic variation of the level of antibody

    RBD-IgG and neutralizing antibody level after vaccination at 1,3 and 6 ,12months vaccination.

    Time frame: 1,3,6 , 12 month

  2. 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.

    Time frame: 1,3,6,12 month

  3. 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.

    Time frame: 1,3,6,12 month

07

Study locations

1 site
  • Beijing Center for Disease Control and Prevention
    Beijing, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Aug 2021, 13 months.

Of 1,641 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 13 months is close to that.

Counting every sponsor, half of 1,775 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 29, 2021
First posted
Oct 11, 2021
StartActual
Jul 20, 2020
Primary completionActual
Aug 30, 2021
CompletionActual
Sep 27, 2021
Last update
Oct 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05072496
Lead sponsor
Centers for Disease Control and Prevention, China
Responsible party
Wu Jiang (Director of Institute for Vaccines and Immunization, Centers for Disease Control and Prevention, China) — Principal investigator
First posted
Oct 11, 2021
Start date
Jul 20, 2020
Primary completion
Aug 30, 2021
Completion
Sep 27, 2021
Last update
Oct 11, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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