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

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:

MedlinePlus related topics: Anthrax

Drug Information available for: Algeldrate

U.S. FDA Resources

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:	November 2013
Estimated Primary Completion Date:	June 2012 (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:

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 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

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

Contacts

Contact: Myoung-don Oh, M.D.

82-2-2072-2945

mdohmd@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Yeongeon-dong, Seoul, Korea, Republic of, 110-744
Contact: Myoung-don Oh, M.D. 82-2-2072-2945 mdohmd@snu.ac.kr
Principal Investigator: Myoung-don Oh, M.D.

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 19, 2012
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 May 23, 2013