AnthraxPhase 2GC1109NCT01624532

A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109

A Phase 2 study of Anthrax, run by Green Cross Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects. Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Anthrax
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 1 siteSouth Korea
Study dates: 14 Jul 2021to 19 Dec 2022
Phase: Phase 2
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 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy 18 to 55 year-olds of either sex
Body mass index above 18.5kg/m2 or below 30kg/m2 at the screening time
A medical history without clinically significant congenital or chronic disease at the screening test before administrating the study drug within 28 days
Agreement to avoid pregnancy or use contraceptive measure between 1 week prior to first dose and the 4 weeks following the final administration
Female subjects of childbearing age, have negative serum β-HCG prior to infuse the study drug within 7 days and urine test at the every pre-vaccine
Signed, informed voluntarily consents the clinical trials

Show all 18Show fewer

Willingness and agreement to comply with the constraints of the study protocol and ability to understand the study
Willingness and ability to return for all follow-up visits and blood draws for the duration of the study
Subjects who can have the study vaccine administered into the deltoid muscle and don't have the tattoo
Agreement to stop drinking for 7days following the administration of the each study vaccine
Agreement not to donate the blood for 24 hours following the administration of the each study vaccine
Healthy 19 to 65 year-olds of either sex
A medical history without clinically significant congenital or chronic disease at the screening test before administrating the study drug within 28 days.
For woman of childbearing age who have not undergone sterilization operation and woman who have not been more than 12 months after menopause, those who agree to avoid pregnancy or use appropriate contraceptive measure for the duration of the study from within one week prior to the first clinical drug administration. Man, who agree to avoid pregnancy or use contraceptive measure for the duration of the study
Female subjects of childbearing age, have negative in pregnancy test at the screening visit
Signed, informed voluntarily consents the clinical trials
Subjects who can have the study drug administered into the deltoid muscle and don't have the tattoo
Agreement not to donate the blood for the duration of the study

Who cannot join

Prior history of, or known exposure to any form of B.anthracis or any anthrax immunization
Employment in an industry involved in contact with ruminant animals, slaughterhose workers, handle the animal raw hides or raw wool, veterinary sciences involving ruminant animals, suspect exposure to any form of B. or anthrax immunization producer and developer.
HIV positive or syphilis HAV, HBV, HCV positive or suspect
Clinically significant out-of-range of laboratory tests at screening including : hypernatremia, hyponatremia, hypopotassemia, hyperchloremia, hypoproteinemia
Prior history of, immunodeficiency or clinically active autoimmune disease
Subjects with a history of Guillain-Barre syndrome

Show all 40Show fewer

Subjects with hemophilia or being treated with an anticoagulant who are at increased risk of serious bleeding during intramuscular injection
History or evidence of metastatic malignancy tumor for internal organs, blood or flesh
Medical significant hypersensitivity or idiosyncratic reaction related to any medical product including study drug or with a history of anaphylaxis
Subjects who have had an acute fever exceeding a body temperature of 38.0℃ within 72 hours prior to the administration of the study vaccine, or who have had a symptom suspicious for acute febrile disease within 14 days prior to the administration of the study vaccine.
Individuals who have received or intend to receive medication within 30 days of injection of the any experimental drug
Donation of blood within 30 days prior to administrate the study drug
Subjects who have received or are scheduled for the treatment with the following drug within 120 days (except for inhaled, nasal or topical corticosteroid)
Subjects who have received or are scheduled for the treatment with the following drug within 120 days (except for inhaled, nasal or topical corticosteroid)
Systemic immunosuppressant therapy, radiotherapy, a high dose of steroid at the similar dose level
Blood-derived products including immunoglobulin
Systemic immunosuppressant therapy, radiotherapy, a high dose of steroid at the similar dose level Blood-derived products including immunoglobulin
Subjects who have received or are scheduled for the treatment with the following drug within the specified period
Pre-injection of the IP within 30 days: oriental medicine
Pre-injection of the IP within 7 days: ethical the counter drug (ETC), over the counter
History or suspect of drug abuse (Amphetamine, barbiturates, cocaine, opioids, benzodiazepines etc)
Subject without safety for the administration of vaccine, who in the investigator's opinion are unsuitable for the study or disturb the assessment of clinical trials
Step2
Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization
Employees in an industry involved in contact with ruminant animals(slaughterhouse workers, handle the animal raw hides or raw wool, veterinary sciences involving ruminant animals, suspect exposure to any form of B. or anthrax), immunization producer and developer.
HIV positive or suspect
HAV, HBV, HCV positive or suspect
Prior history of, immunodeficiency or clinically active autoimmune disease
Subjects with a history of Guillain-Barre syndrome
Subjects with hemophilia or being treated with an anticoagulant who are at increased risk of serious bleeding during intramuscular injection
History or evidence of metastatic malignancy tumor for internal organs, blood or flesh
Medical significant hypersensitivity, idiosyncratic reaction related to any medical product included in study drug or with a history of anaphylaxis
Subjects who have had an acute fever exceeding a body temperature of 38.0℃ within 72 hours prior to the administration of the study vaccine, or who have had a symptom suspicious for acute febrile disease within 14 days prior to the administration of the study drug.
A person who has received a split vaccine, inactivated vaccine, or actived vaccine within four weeks prior to administration of a study drug
Subjects who have received or are scheduled for the treatment with the following drug within 120 days (except for inhaled, nasal or topical corticosteroid)
Systemic immunosuppressant therapy, radiotherapy, a high dose of steroid at the similar dose level
Blood-derived products including immunoglobulin
A person who has a history of drug abuse within 6 months prior to the administration of a study drug or suspected of taking drugs for fear of abuse through questionnaire and physical examination
Pregnant women and lactating women
A person whom the investigator determined unsuitable for the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: A Phase 2 Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects

The purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.

Read the detailed description

Step 1 Primary objective

Investigate the optimum volume of GC1109 to compare the subject ratio after seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3 times with the immunogenicity of each treatment (GC1109 and placebo cohort) in healthy adults.
In healthy adults, three times the clinical dose of about four weeks, compare immunogenicity of each treatment group (GC1109 group and the placebo group) with subsects ratio who have been Seroconversion for Anti-PA Ab by TNA Secondary objective
Percentage of subjects after seroconversion in each anti-PA IgG level (by ELISA) at 4 weeks following infuse the drug 3 times in healthy adults
Check the Seroprotection antibody titer (survival rate : 50%) with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults
Establish the Seroconversion rate from the percentage of subjects after seroconversion at 4 weeks following infuse the drug 3 times and seroprotection antibody titer in healthy adults
Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA Ab by TNA for 4 weeks following infuse the drug 3 times
Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA IgG by ELISA for 4 weeks following infuse the drug 3 times
Determine the safety of the each treatment cohort

Step 2

Primary objective

Evaluate whether the Toxin Neutralization Antibody by TNA assay satisfy the NF50 standard or not at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults.

Secondary objective

Establish the safety of the GC1109 in healthy adults
Establish the GMT of Toxin Neutralization Antibody by TNA assay after infusing the drug 4 times until 24 weeks in healthy adults
Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 4 times until 24 weeks in healthy adults

Conditions: Anthrax
Being tested: GC1109 or Placebo of GC1109
Keywords: Anthrax vaccine
Medical subject headings: Anthrax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GC1109 or Placebo of GC1109Biological
Also called rPA or Placebo
Step1: Administer 0.3mL or 0.5mL or 0.1mL or placebo of GC1109 into the deltoid muscle three times every four weeks.
Step2: Administer 1.0mL of GC1109 or placebo of GC1109 into the deltoid muscle three times every four weeks, and once after 24 weeks.

Study groups in NCT01624532
Study group	Role	What they receive
GC1109	Experimental	Step1: GC1109 0.3 mL or 0.5 mL or 0.1mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects Step2: GC1109 1.0 mL administered in Multi Intramuscular Doses (4 times) to Healthy Subjects Receives: Biological: GC1109 or Placebo of GC1109
Placebo of GC1109	Placebo comparator	Step1: Placebo of GC1109 0.5mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects Step2: Placebo of GC1109 1.0 mL administered in Multi Intramuscular Doses (4 times) to Healthy Subjects Receives: Biological: GC1109 or Placebo of GC1109

What is being measured

The primary outcome is the main question the study is designed to answer.

Step 1) Investigate the optimum volume of GC1109
Investigate the optimum volume of GC1109 to compare the subject ratio after seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3 times with the immunogenicity of each treatment (GC1109 and placebo cohort) in healthy adults.
Measured: at 4 weeks following infuse the drug 3 times
Step 2) Toxin Neutralization Antibody (by TNA assay) of GC1109
Percentage of subjects with an 0.56 or higher NF50 by evaluating Toxin Neutralization Antibody (by TNA assay) at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults.
Measured: at 4 weeks following infuse the drug 4 times

Secondary outcomes (8)

Step 1) Percentage of subjects after seroconversion
Percentage of subjects after seroconversion in each anti-PA IgG level (by ELISA) at 4 weeks following infuse the drug 3 times in healthy adults
Measured: for 4 weeks following infuse the drug 3 times
Step 1) Check the Seroprotection antibody titer
Check the Seroprotection antibody titer with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults
Measured: for 4 weeks following infuse the drug 3 times
Step 1) Seroconversion rate
Establish the Seroconversion rate from the percentage of subjects after seroconversion at 4 weeks following infuse the drug 3 times and seroprotection antibody titer in healthy adults
Measured: for 4 weeks following infuse the drug 3 times
Step 1) Compare the immunogenicity with GMT by TNA
Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA Ab by TNA for 4 weeks following infuse the drug 3 times
Measured: for 4 weeks following infuse the drug 3 times
Step 1) Compare the immunogenicity with the GMT by ELISA
Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA IgG by ELISA for 4 weeks following infuse the drug 3 times
Measured: for 4 weeks following infuse the drug 3 times
Step 1), Step 2) Adverse Events
Adverse events such as subjective and objective symptoms
Measured: By 24 weeks following infuse the drug 4 times
Step 2) GMT of Toxin Neutralization Antibody by TNA assay
Establish the GMT of Toxin Neutralization Antibody by TNA assay after infusing the drug 4 times until 24 weeks in healthy adults
Measured: By 24 weeks following infuse the drug 4 times
Step 2)GMT of Anti-PA IgG by ELISA
Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 4 times until 24 weeks in healthy adults
Measured: By 24 weeks following infuse the drug 4 times

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jul 202119 Dec 2022

First posted20 Jun 2012 (estimated)
Study start14 Jul 2021
Primary completion2 Aug 2022
Study completion19 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnthraxStudies 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: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Step 1 (Number of Arms: 4), Step 2 (Number of Arms: 2)
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01624532
Sponsor's protocol ID: GC1109_P2
Other IDs: GC1109
Acronym: GC1109
Status last verified: Jan 2023
First submitted: 6 Mar 2012
Last updated: 4 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects
ClinicalTrials.gov ID: NCT01624532
Acronym / sponsor ID: GC1109 / GC1109_P2
Conditions: Anthrax
Keywords: Anthrax vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Green Cross CorporationIndustry (pharma, biotech, devices)
Collaborators: Korean Center for Disease Control and Prevention
Study start: 14 Jul 2021 (actual)
Primary completion: 2 Aug 2022 (actual)
Study completion: 19 Dec 2022 (actual)
First posted: 20 Jun 2012 (estimated)
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 purpose of this study is to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Administered in Multi Intramuscular Doses to Healthy Subjects.

Detailed description

Step 1 Primary objective

Investigate the optimum volume of GC1109 to compare the subject ratio after seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3 times with the immunogenicity of each treatment (GC1109 and placebo cohort) in healthy adults.
In healthy adults, three times the clinical dose of about four weeks, compare immunogenicity of each treatment group (GC1109 group and the placebo group) with subsects ratio who have been Seroconversion for Anti-PA Ab by TNA Secondary objective
Percentage of subjects after seroconversion in each anti-PA IgG level (by ELISA) at 4 weeks following infuse the drug 3 times in healthy adults
Check the Seroprotection antibody titer (survival rate : 50%) with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults
Establish the Seroconversion rate from the percentage of subjects after seroconversion at 4 weeks following infuse the drug 3 times and seroprotection antibody titer in healthy adults
Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA Ab by TNA for 4 weeks following infuse the drug 3 times
Compare the immunogenicity of each treatment with the GMT's assessment of Anti-PA IgG by ELISA for 4 weeks following infuse the drug 3 times
Determine the safety of the each treatment cohort

Step 2

Primary objective

Evaluate whether the Toxin Neutralization Antibody by TNA assay satisfy the NF50 standard or not at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults.

Secondary objective

Establish the safety of the GC1109 in healthy adults
Establish the GMT of Toxin Neutralization Antibody by TNA assay after infusing the drug 4 times until 24 weeks in healthy adults
Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 4 times until 24 weeks in healthy adults

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Step 1 (Number of Arms: 4), Step 2 (Number of Arms: 2)

Arm	Type	Receives
GC1109	Experimental	Biological: GC1109 or Placebo of GC1109Step1: GC1109 0.3 mL or 0.5 mL or 0.1mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects Step2: GC1109 1.0 mL administered in Multi Intramuscular Doses (4 times) to Healthy Subjects
Placebo of GC1109	Placebo comparator	Biological: GC1109 or Placebo of GC1109Step1: Placebo of GC1109 0.5mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects Step2: Placebo of GC1109 1.0 mL administered in Multi Intramuscular Doses (4 times) to Healthy Subjects

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Healthy 18 to 55 year-olds of either sex
Body mass index above 18.5kg/m2 or below 30kg/m2 at the screening time
A medical history without clinically significant congenital or chronic disease at the screening test before administrating the study drug within 28 days
Agreement to avoid pregnancy or use contraceptive measure between 1 week prior to first dose and the 4 weeks following the final administration
Female subjects of childbearing age, have negative serum β-HCG prior to infuse the study drug within 7 days and urine test at the every pre-vaccine

Key exclusion criteria (40 listed)

Prior history of, or known exposure to any form of B.anthracis or any anthrax immunization
Employment in an industry involved in contact with ruminant animals, slaughterhose workers, handle the animal raw hides or raw wool, veterinary sciences involving ruminant animals, suspect exposure to any form of B. or anthrax immunization producer and developer.
HIV positive or syphilis HAV, HBV, HCV positive or suspect
Clinically significant out-of-range of laboratory tests at screening including : hypernatremia, hyponatremia, hypopotassemia, hyperchloremia, hypoproteinemia
Prior history of, immunodeficiency or clinically active autoimmune disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GC1109 or Placebo of GC1109Also: rPA or PlaceboStep1: Administer 0.3mL or 0.5mL or 0.1mL or placebo of GC1109 into the deltoid muscle three times every four weeks. Step2: Administer 1.0mL of GC1109 or placebo of GC1109 into the deltoid muscle three times every four weeks, and once after 24 weeks.	Biological	GC1109, Placebo of GC1109

Primary outcome

Step 1) Investigate the optimum volume of GC1109
Time frame: at 4 weeks following infuse the drug 3 times
Investigate the optimum volume of GC1109 to compare the subject ratio after seroconversion in each Anti-PA Ab by TNA at 4 weeks following infuse the drug 3 times with the immunogenicity of each treatment (GC1109 and placebo cohort) in healthy adults.
Step 2) Toxin Neutralization Antibody (by TNA assay) of GC1109
Time frame: at 4 weeks following infuse the drug 4 times
Percentage of subjects with an 0.56 or higher NF50 by evaluating Toxin Neutralization Antibody (by TNA assay) at 4 weeks following infuse the optimal dose of GC1109 4 times in healthy adults.

8 secondary outcomes

Step 1) Percentage of subjects after seroconversion
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Check the Seroprotection antibody titer
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Seroconversion rate
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Compare the immunogenicity with GMT by TNA
Time frame: for 4 weeks following infuse the drug 3 times
Step 1) Compare the immunogenicity with the GMT by ELISA
Time frame: for 4 weeks following infuse the drug 3 times
Step 1), Step 2) Adverse Events
Time frame: By 24 weeks following infuse the drug 4 times
Step 2) GMT of Toxin Neutralization Antibody by TNA assay
Time frame: By 24 weeks following infuse the drug 4 times
Step 2)GMT of Anti-PA IgG by ELISA
Time frame: By 24 weeks following infuse the drug 4 times

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 4 Jan 2023.

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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.

Nam Joong Kim, M.D. principal investigator

Seoul National University Hospital

Seong Heon Wie, M.D. principal investigator

Saint Vincent's Hospital, Korea

Won Suk Choi, M.D. principal investigator

Korea University Asan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Anthrax, run by Green Cross Corporation at 1 site in South Korea.

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 18 inclusion and 40 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 4 Jan 2023. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Step 1) Investigate the optimum volume of GC1109 (time frame: at 4 weeks following infuse the drug 3 times). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01624532.

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 4 Jan 2023.