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

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.

Study Overview

• Status: Completed
• Conditions: Anthrax
• Intervention / Treatment: Biological: GC1109 or Placebo of GC1109

Detailed Description

1. 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
2. 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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Step1

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GC1109; 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	Biological: GC1109 or Placebo of GC1109; 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.; Other Names: rPA or Placebo
Placebo Comparator: Placebo of GC1109; 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	Biological: GC1109 or Placebo of GC1109; 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.; Other Names: rPA or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	at 4 weeks following infuse the drug 4 times

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	for 4 weeks following infuse the drug 3 times
Step 1), Step 2) Adverse Events	Adverse events such as subjective and objective symptoms	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	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	By 24 weeks following infuse the drug 4 times

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Collaborators: Korean Center for Disease Control and Prevention
• Investigators: Principal Investigator: Nam Joong Kim, M.D., Seoul National University Hospital; Principal Investigator: Seong Heon Wie, M.D., Saint Vincent's Hospital, Korea; Principal Investigator: Won Suk Choi, M.D., Korea University Asan Hospital; Principal Investigator: Eun Jung Lee, M.D., Soonchunhyang University Hospital; Principal Investigator: Jacob Lee, M.D., Hallym University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Anthrax vaccine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Bacillaceae Infections; Anthrax
• Other Study ID Numbers: GC1109_P2; GC1109 (Registry Identifier: Green Cross Croporation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No