ClinicalTrials.gg
Enrolling by invitationNCT07936188GC4006AUpdated Nov 13, 2026

Phase 2 Study of GC4006A in Healthy Adults

A Phase 2 interventional study of GC4006A and GC4006A in Covid-19 Prevention, sponsored by GC Biopharma Corp. Enrolling by invitation at 1 site in South Korea. Open to participants aged 19 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by GC Biopharma Corp · Phase 2, Interventional, and Prevention

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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

Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
19 Years to 85 Years
Sex
All
01

Where this study stands

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

Among 90 studies in COVID-19 with a site in Korea, Republic of — 11 open to participants now, 19 under way, 6 of them phase 3. COVID-19 · Korea, Republic of.

Planned enrollment
39th of 72
210 · median 253
Started
2026
with 3 others
Phase 2
17 of 90
2 open now
Primary completion
2027-10
later than 11 of 18 live
Registered
90th of 90
by date

Among the 90 studies in COVID-19 with a site in Korea, Republic of, this one is the 39th largest by planned enrollment of the 72 interventional ones that give a count, is one of 4 that started in 2026, is one of 17 in phase 2, reaches primary completion later than 11 of the 18 other live ones, and was the 90th registered.

COVID-19

7,993 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

11 of the 90 studies in COVID-19 with a site in Korea, Republic of are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

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

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: 19 Years to 85 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 90 studies in COVID-19 with a site in Korea, Republic of, or all of them as a file.
02

Study summary

The purpose of this study is to evaluate the safety and immunogenicity of the COVID-19 preventive vaccine 'GC4006A' in healthy adults aged 19 to 85 years

03

Conditions studied

  • Covid-19 Prevention

Browse trials for

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Age 19-85 with written
  • ≥16 weeks since last COVID-19 vaccination

Exclusion criteria

Exclusion Criteria:

  • Positive SARS-CoV-2 test (RT-PCR/Rapid Antigen) at screening or randomization
  • \<16 weeks since COVID-19 diagnosis
  • History of serious adverse event, allergy, or to the vaccines
  • Pregnant or lactating women
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    GC4006A (Dose A)

    Biological: GC4006A

  • Experimental
    GC4006A (Dose B)

    Biological: GC4006A

  • Active comparator
    Comirnaty

    Biological: COMIRNATY

Interventions

  • BiologicalGC4006A

    Intramuscular injection

  • BiologicalGC4006A

    Intramuscular injection

  • BiologicalCOMIRNATY

    Intramuscular injection

06

What researchers measure

Primary outcomes

  1. Differences between groups of Neutralizing Antibody Responses

    Assessed by Geometric Mean Titer (GMT, unit: BAU/ml), Geometric Mean Fold Rise (GMFR) from baseline, and Seroresponse Rate (SRR, unit: %). GMFR is expressed as a fold-change without units.

    Time frame: up to 4 weeks

  2. Differences between groups of Binding Antibody Responses

    Assessed by Geometric Mean Concentration (GMC, unit: BAU/ml), Geometric Mean Fold Rise (GMFR) from baseline, and Seroresponse Rate (SRR, unit: %). GMFR is expressed as a fold-change without units.

    Time frame: up to 4 weeks

Secondary outcomes

  1. Differences between groups of Neutralizing Antibody Responses

    Assessed by Geometric Mean Titer (GMT, unit: BAU/ml), Geometric Mean Fold Rise (GMFR) from baseline, and Seroresponse Rate (SRR, unit: %). GMFR is expressed as a fold-change without units.

    Time frame: up to 52 weeks

  2. Differences between groups of Binding Antibody Responses

    Assessed by Geometric Mean Concentration (GMC, unit: BAU/ml), Geometric Mean Fold Rise (GMFR) from baseline, and Seroresponse Rate (SRR, unit: %). GMFR is expressed as a fold-change without units.

    Time frame: up to 52 weeks

  3. Change from baseline of T-Cell Mediated Immune Responses

    Evaluated by IFN-gamma-secreting T-cell responses and present Th1/Th2 ratio in %.

    Time frame: up to 52 weeks

  4. Incidence of Solicited Local and Systemic Adverse Events

    Time frame: up to 1 weeks

  5. Incidence of Unsolicited Adverse Events

    Time frame: up to 4 weeks

  6. Incidence of Immediate Adverse Events

    Time frame: up to 30 minutes

  7. Incidence of Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs)

    Time frame: up to 52 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update 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

Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.

Of 223 industry-sponsored phase 2 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's planned 12 months is above that.

Counting every sponsor, half of 582 studies reached it within 9 months; a quarter within 5 and three quarters within 16.

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

Registered
Oct 21, 2026
First posted
Nov 13, 2026
StartActual
Oct 26, 2026
Primary completionEst.
Oct 2027
CompletionEst.
May 2028
Last update
Nov 13, 2026
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.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936188
Lead sponsor
GC Biopharma Corp
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Oct 26, 2026
Primary completion
Oct 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Nov 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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