HealthyPhase 1NCT01184976

Study Of VGX-3400, H5N1 Avian Flu Virus Plasmid DNA With Electroporation Device In Healthy Adult Males

A Phase 1 study testing VGX-3400 in people with Healthy, run by GeneOne Life Science, Inc. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Research Hypothesis: VGX-3400 (DNA plasmids encoding the hemagglutinin (HA), neuraminidase (NA), and M2e-NP antigen of the H5N1 avian influenza virus) administered to healthy adult males by IM injection followed by EP will be generally well tolerated and immunogenic. Read more about this study

Who is it for?: Ages 20 to 39 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: VGX-3400
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesSouth Korea
Study dates: Aug 2010to Apr 2012
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 20 to 39 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI)
Male subjects 20-39 years of age
Healthy subjects as judged by the Investigator based on medical history, physical examination, and normal results for an ECG, CBC, serum chemistries, CPK and urinalysis done up to 30 days prior to enrollment and administration of study drug
Current nonsmoker
Body mass index (BMI) ≤30 kg/m2
Able and willing to comply with all study procedures.

Who cannot join

Positive serological test for HIV virus, hepatitis C virus or hepatitis B virus surface antigen (HBsAg);
Any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids); or the use of immunosuppressive or immune modifying agents within 3 months prior to Day 0 other than corticosteroids; or systemic or topical corticosteroids which must be discontinued > 4 weeks prior to Day 0
Administration of any blood product within 3 months of enrollment
Prior receipt of an H5N1 influenza vaccine at any time
Administration of any non-study vaccine in the 6 weeks prior to study enrollment
Subject is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent;

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Metal implants at the site of injection, however, metal implants elsewhere are permitted and do not represent an exclusion criterion;
Active substance abuse or use of drugs such as heroin, cocaine or other drugs of addiction or daily use of alcohol greater than 100 ml of whiskey or other liquor, greater than 300 ml of wine, or greater than 360 ml of beer daily during the study period or in the week prior to starting the study;
Subjects whose deltoid or quadriceps is not available;
Subjects receiving anti-viral drugs \& with primary thrombocytopenia;
Serious Adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain (Not excluded: a participant who had a non-anaphylactic adverse reaction to pertussis vaccine as a child);
Autoimmune disease, including Guillain-Barré syndrome;
Clinically significant medical condition, physical exam findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
A process that would affect the immune response;
A process that would require medication that affects the immune response;
Any contraindication to repeated injections or blood draws;
A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period;
A condition or process for which signs or symptoms could be confused with reactions to vaccine, or;
Any condition specifically listed among the exclusion criteria.
Subjects with known prior illness or who is at risk for H5N1 Influenza A virus infection, i.e. exposure in the two weeks prior to study Day 0 to a person with known H5N1 Influenza virus infection or travel in the 2 weeks prior to Day 0 or during the course of the study to a region with known current cases of H5N1 Influenza virus infection;
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
Any other conditions judged by the investigator that would limit the evaluation of a subject.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

Yonsei University Severance Hospital
Seoul, 120-752
Korea University Anam Hospital
Seoul, 136-705

Other trials in South Korea

About this study

Official title: Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity in Healthy Adult Males of a DNA Plasmid Vaccine for HS Avian Influenza (VGX-3400) Administered by Intramuscular (IM) Injection Followed by Electroporation (EP)

Conditions: Healthy
Being tested: VGX-3400
Keywords: H5N1, Avian Influenza, DNA Vaccine, Electroporation, Intramuscular (IM) Injection
Medical subject headings: Influenza in Birds

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VGX-3400Biological
Plasmid DNA delivered via IM injection with electroporation

Study groups in NCT01184976
Study group	Role	What they receive
0.6mg DNA/dose	Experimental	Subjects will receive a 2 dose series of VGX-3400 containing 0.6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 Receives: Biological: VGX-3400
2mg DNA/dose	Experimental	Subjects will receive a 2 dose series of VGX-3400 containing 2mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 Receives: Biological: VGX-3400
6mg DNA/dose	Experimental	Subjects will receive a 2 dose series of VGX-3400 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 Receives: Biological: VGX-3400

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability
Frequency, severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events
Measured: Day 0 through Month 4

Secondary outcomes (1)

Humoral and cellular Immune Responses
Values of antibody and cell-mediated immune responses to HA, NA and M2e-NP proteins
Measured: Day 0 through Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Apr 2012

First posted19 Aug 2010 (estimated)
Study startAug 2010
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01184976
Sponsor's protocol ID: FLU-001
Status last verified: Mar 2015
First submitted: 16 Aug 2010
Last updated: 17 Mar 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity in Healthy Adult Males of a DNA Plasmid Vaccine for HS Avian Influenza (VGX-3400) Administered by Intramuscular (IM) Injection Followed by Electroporation (EP)
ClinicalTrials.gov ID: NCT01184976
Acronym / sponsor ID: FLU-001
Conditions: Healthy
Keywords: H5N1, Avian Influenza, DNA Vaccine, Electroporation, Intramuscular (IM) Injection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
Collaborators: Inovio Pharmaceuticals
Study start: Aug 2010
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 19 Aug 2010 (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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
0.6mg DNA/dose	Experimental	Biological: VGX-3400Subjects will receive a 2 dose series of VGX-3400 containing 0.6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1
2mg DNA/dose	Experimental	Biological: VGX-3400Subjects will receive a 2 dose series of VGX-3400 containing 2mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1
6mg DNA/dose	Experimental	Biological: VGX-3400Subjects will receive a 2 dose series of VGX-3400 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1

Who may qualify

Ages: 20 to 39 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI)
Male subjects 20-39 years of age
Healthy subjects as judged by the Investigator based on medical history, physical examination, and normal results for an ECG, CBC, serum chemistries, CPK and urinalysis done up to 30 days prior to enrollment and administration of study drug
Current nonsmoker
Body mass index (BMI) ≤30 kg/m2

Key exclusion criteria (22 listed)

Positive serological test for HIV virus, hepatitis C virus or hepatitis B virus surface antigen (HBsAg);
Any concurrent condition requiring the continued use of systemic or topical steroids (excluding inhaled and eye drop-containing corticosteroids); or the use of immunosuppressive or immune modifying agents within 3 months prior to Day 0 other than corticosteroids; or systemic or topical corticosteroids which must be discontinued > 4 weeks prior to Day 0
Administration of any blood product within 3 months of enrollment
Prior receipt of an H5N1 influenza vaccine at any time
Administration of any non-study vaccine in the 6 weeks prior to study enrollment

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
VGX-3400Plasmid DNA delivered via IM injection with electroporation	Biological	0.6mg DNA/dose, 2mg DNA/dose, 6mg DNA/dose

Primary outcome

Safety and Tolerability
Time frame: Day 0 through Month 4
Frequency, severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

1 secondary outcome

Humoral and cellular Immune Responses
Time frame: Day 0 through Month 4

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 17 Mar 2015.

Related trials for Healthy

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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.

Minja Kim principal investigator

Korea Univ. MC

Minsoo Park principal investigator

Severance Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VGX-3400 in people with Healthy, run by GeneOne Life Science, Inc. at 2 sites 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 6 inclusion and 22 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

Safety and Tolerability (time frame: Day 0 through Month 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01184976.

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 17 Mar 2015.