AnthraxPhase 1NCT01867957
Efficacy and Safety of Anthrax Vaccine, GC1109
A Phase 1 study testing Low-dose GC1109 and High-dose GC1109 in people with Anthrax, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies. 2. OBJECTIVE To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers. 3. STUDY DESIGN single-blinded randomized placebo controlled phase 1 study Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- What is being tested?
- Low-dose GC1109 and High-dose GC1109
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Dec 2009
- Phase
- Phase 1
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between 18 and 45 years of age at the time of screening visit
- 18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
- Subjects without congenital or chronic disorder
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men
- BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
- OBJECTIVE
- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
- STUDY DESIGN
- single-blinded
- randomized
- placebo controlled
- phase 1 study
- Conditions
- Anthrax
- Being tested
- Low-dose GC1109, High-dose GC1109, Low-dose Placebo, High-dose Placebo
- Keywords
- anthrax, vaccine, bioterrorism, efficacy, safety
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose GC1109Biological
Also called GC1109 50ug/dose (0.5 ml) vaccination
50ug/dose
High-dose GC1109Biological
Also called GC1109 100ug/dose (1.0 ml) vaccination
100ug/dose
Low-dose PlaceboBiological
Also called 0.9% Saline 0.5 mL vaccination
0.9% Saline 0.5 mL
High-dose PlaceboBiological
Also called 0.9% Saline 1.0 mL vaccination
0.9% Saline 1.0 mL
| Study group | Role | What they receive |
|---|---|---|
| Low-dose GC1109 | Experimental | Not described Receives: Biological: Low-dose GC1109 |
| Low-dose Placebo | Placebo comparator | Not described Receives: Biological: Low-dose Placebo |
| High-dose GC1109 | Experimental | Not described Receives: Biological: High-dose GC1109 |
| High-dose Placebo | Placebo comparator | Not described Receives: Biological: High-dose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Measured: 0 - 28 Days
Secondary outcomes (2)
Anti-protective antigen(PA) antibody level (by TNA)
Measured: Day 14, Day 28
Anti-PA Immunoglobulin G (IgG) (by ELISA)
Measured: Day 14, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionDec 2009
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation, LSK Global Pharma Services Co. Ltd.
- Responsible party
- Principal investigator, Myoung-don Oh, Seoul National University Hospital
- Investigators
- Myoung-don Oh, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867957
- Sponsor's protocol ID
- GC1109_P1_v1.2
- Status last verified
- Jun 2013
- First submitted
- 30 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blind, Randomized, Placebo Control, Phase I Study to Evaluate the Safety and Immunogenicity of the GC1109 Administered by the Intramuscular Route in Healthy Men
- ClinicalTrials.gov ID
- NCT01867957
- Acronym / sponsor ID
- GC1109_P1_v1.2
- Conditions
- Anthrax
- Keywords
- anthrax, vaccine, bioterrorism, efficacy, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Green Cross Corporation, LSK Global Pharma Services Co. Ltd.
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Jun 2013 (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.
- BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
- OBJECTIVE
- To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
- STUDY DESIGN
- single-blinded
- randomized
- placebo controlled
- phase 1 study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose GC1109 | Experimental | Biological: Low-dose GC1109 |
| Low-dose Placebo | Placebo comparator | Biological: Low-dose Placebo |
| High-dose GC1109 | Experimental | Biological: High-dose GC1109 |
| High-dose Placebo | Placebo comparator | Biological: High-dose Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects between 18 and 45 years of age at the time of screening visit
- 18.5kg/m2 ≤BMI < 30kg/m2 at the time of screening visit
- Subjects without congenital or chronic disorder
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Low-dose GC1109Also: GC1109 50ug/dose (0.5 ml) vaccination50ug/dose | Biological | Low-dose GC1109 |
| High-dose GC1109Also: GC1109 100ug/dose (1.0 ml) vaccination100ug/dose | Biological | High-dose GC1109 |
| Low-dose PlaceboAlso: 0.9% Saline 0.5 mL vaccination0.9% Saline 0.5 mL | Biological | Low-dose Placebo |
| High-dose PlaceboAlso: 0.9% Saline 1.0 mL vaccination0.9% Saline 1.0 mL | Biological | High-dose Placebo |
Primary outcome
Adverse Event
Time frame: 0 - 28 Days
2 secondary outcomes
Anti-protective antigen(PA) antibody level (by TNA)
Time frame: Day 14, Day 28
Anti-PA Immunoglobulin G (IgG) (by ELISA)
Time frame: Day 14, Day 28
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 5 Jun 2013.
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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.
Myoung-don Oh, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-dose GC1109 and High-dose GC1109 in people with Anthrax, run by Seoul National University Hospital 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 3 inclusion and 1 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 5 Jun 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse Event (time frame: 0 - 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2013.