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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01624532
First received: March 6, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Anthrax
Biological: rPA vaccine containing alhydrogel 1.0 mL
Drug: Normal Saline
Biological: rPA vaccine containing alhydrogel 0.5 mL
Biological: rPA vaccine containing alhydrogel 0.3 mL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Investigate the optimum volume of GC1109 [ Time Frame: at 4 weeks following infuse the drug 3 times ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Percentage of subjects after seroconversion [ Time Frame: at 4 weeks following infuse the drug 3 times ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at 4 weeks following infuse the drug 3 times ] [ Designated as safety issue: Yes ]
    Check the Seroprotection antibody titer with passive immune (nonclinical tests) at 4 weeks following infuse the drug 3 times in healthy adults

  • Seroconversion rate [ Time Frame: at 4 weeks following infuse the drug 3 times ] [ Designated as safety issue: Yes ]
    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 with GMT by TNA [ Time Frame: for 4 weeks following infuse the drug 3 times ] [ Designated as safety issue: Yes ]
    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 with the GMT by ELISA [ Time Frame: for 4 weeks following infuse the drug 3 times ] [ Designated as safety issue: Yes ]
    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

  • Adverse Events [ Time Frame: baseline through 8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 299
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rPA vaccine containing alhydrogel 1.0 mL
GC1109 1.0 mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects
Biological: rPA vaccine containing alhydrogel 1.0 mL
rPA vaccine containing alhydrogel 1.0 mL
Other Name: GC1109
Placebo Comparator: Normal Saline
Normal Saline 0.5 mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects
Drug: Normal Saline
Normal Saline 0.5mL
Other Name: Normal Saline
Experimental: rPA vaccine containing alhydrogel 0.5 mL
GC1109 0.5 mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects
Biological: rPA vaccine containing alhydrogel 0.5 mL
rPA vaccine containing alhydrogel 0.5 mL
Other Name: GC1109
Experimental: rPA vaccine containing alhydrogel 0.3 mL
GC1109 0.3 mL administered in Multi Intramuscular Doses (3 times) to Healthy Subjects
Biological: rPA vaccine containing alhydrogel 0.3 mL
rPA vaccine containing alhydrogel 0.3 mL
Other Name: 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 the immunogenicity of GC1109 at 4 weeks following infuse the optimal dose drug 3 times, whether the data induced from Step 1 satisfy the Seroconversion rate or not.

Secondary objective

  • Establish the safety and most desirable level of the GC1109's dosage in healthy adults
  • Establish the GMT of Anti-PA Ab by TNA after infusing the drug 3 times until 4 weeks in healthy adults
  • Establish the GMT of Anti-PA IgG by ELISA after infusing the drug 3 times until 4 weeks in healthy adults
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 in female subjects of childbearing age. For man, who agree to avoid pregnancy or use contraceptive measure for 3 months 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)
  • Vaccine
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624532

Locations
Korea, Republic of
Seoul National University Hospital
Yeongeon-dong, Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Green Cross Corporation
Korean Center for Disease Control and Prevention
Investigators
Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01624532     History of Changes
Other Study ID Numbers: GC1109_P2, GC1109
Study First Received: March 6, 2012
Last Updated: June 27, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Green Cross Corporation:
Anthrax vaccine

Additional relevant MeSH terms:
Anthrax
Bacillaceae Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014