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

NCT01624532 | Completed Phase 2

• 2 other identifiers: GC1109_P2GC1109
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anthrax

Keywords

Anthrax vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Step 1) Percentage of subjects after seroconversion

  for 4 weeks following infuse the drug 3 times

• Step 1) Check the Seroprotection antibody titer

  for 4 weeks following infuse the drug 3 times

• Step 1) Seroconversion rate

  for 4 weeks following infuse the drug 3 times

• Step 1) Compare the immunogenicity with GMT by TNA

  for 4 weeks following infuse the drug 3 times

• Step 1) Compare the immunogenicity with the GMT by ELISA

  for 4 weeks following infuse the drug 3 times

Study Arms (2)

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

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

Biological: GC1109 or Placebo of GC1109

Interventions

GC1109 or Placebo of GC1109 BIOLOGICAL

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.

Also known as: rPA or Placebo

GC1109; Placebo of GC1109

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead
• Korean Center for Disease Control and Prevention: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Anthrax

Interventions

Replication Protein A

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Step 1 (Number of Arms: 4), Step 2 (Number of Arms: 2)

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: June 20, 2012
• Study Start: July 14, 2021
• Primary Completion: August 2, 2022
• Study Completion: December 19, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

KR (1)