ClinicalTrials.gg
Status unknownNCT05087277Updated Oct 21, 2021

Correlation Study of Isotype Switching and Neutralizing Capacity to the COVID-19 Variants Strain

An observational study in COVID-19, sponsored by Centers for Disease Control and Prevention, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-21.

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

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

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
189th 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 189th 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.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 472 studies in COVID-19 with a site in China, or all of them as a file.
02

Study summary

The level of neutralizing antibody was detected by using the constructed pseudovirus covid-19 variant at baseline , 1 month , 6 months and 12 months after primary vaccination, within 15 days after booster immunization at 12 months . and the ability of IgG subclasses to neutralize and cross immunization of variant strains was analyzed.

Read the detailed description

In 150 individuals who received primary and booster COVID-19 inactivated vaccine, the neutralization ability of antibodies against covid-19 mutant after primary and booster immunization was evaluated by constructing pseudotyped SARS-CoV-2 variants. The contribution and influence of IgG subclasses on neutralization capacity were assessed by Elisa assay. 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 was required blood sampling at the day 0 of first dose vaccine and 1 month, 6 months after 2nd dose of primary immunization. All participants had received 1 dose of booster immunization at 12 months after fully primary vaccination. Then 150 people were divided into four groups, Blood samples were taken on days 0,3,7,10 and 14 to detect neutralizing antibodies and IgG subclasses separately. every sample was detected SARS-CoV-2 variants strain Alpha, Beta and Delta neutralizing antibody, and RBD-IgG1, IgG2, IgG3, and IgG4. every individual was conducted a detailed analysis correlation of isotype switching, neutralizing antibody titer and cross immunity against COVID-19 variants after primary and booster vaccination.

03

Conditions studied

  • COVID-19

Browse trials for

Keywords

  • cohort study
  • Isotype Switching
  • Neutralize antibodies
  • COVID-19 Variants Strain
04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
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

  • Between the ages of 18 and 59
  • Healthy
  • No vaccination with COVID-19 before become participant
  • 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 without dna
06

What researchers measure

Primary outcomes

  1. Neutralizing capabilities to variant COVID-19 after primary and booster vaccination

    The titers of neutralizing antibodies against live SARS-CoV-2 and Pseudotyped SARS-CoV-2 Variants strain Alpha, Beta and Delta at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at 12 months. The neutralizing antibodies was defined as a change from seronegative at baseline to seropositive or a four-fold titer increase. The positive cutoff of the titer for neutralizing antibodies was 1/30.

    Time frame: Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at 12 months

  2. Titer of Subclass of IgG after primary and booster vaccination

    The titers of Subclass RBD-specific IgG1, IgG2,IgG3 and IgG4 at baseline, after fully vaccinated 1 and 6 months and Within 15 days after booster immunization at an interval of 12 months. The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.

    Time frame: Baseline,After fully vaccinated 1 and 6 months,Within 15 days after booster immunization at an interval of 12 months

Secondary outcomes

  1. Titer of subclass of IgG at different points in time after booster vaccination

    Titer of subclass of IgG at 0,3,7,10,14 days after booster vaccination. The positive for IgG1, IgG2,IgG3 and IgG4 antibodies are defined as the sample titer value ≥1/20.

    Time frame: 0,3,7,10,14 days

07

Study locations

1 site
  • Center for Disease Control and Prevention
    Beijing, 100013, 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 Oct 2021, 14 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 14 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
Oct 19, 2021
First posted
Oct 21, 2021
StartActual
Jul 20, 2020
Primary completionActual
Oct 10, 2021
CompletionEst.
Oct 30, 2021
Last update
Oct 21, 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 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05087277
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 21, 2021
Start date
Jul 20, 2020
Primary completion
Oct 10, 2021
Completion
Oct 30, 2021 (estimated)
Last update
Oct 21, 2021

Oversight

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

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion