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

NCT01184976 | Completed Phase 1 DMC

• 1 other identifier: FLU-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Keywords

H5N1; Avian Influenza; DNA Vaccine; Electroporation; Intramuscular (IM) Injection

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Frequency, severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

  Day 0 through Month 4

Secondary Outcomes (1)

• Humoral and cellular Immune Responses

  Day 0 through Month 4

Study Arms (3)

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

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

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

Biological: VGX-3400

Interventions

VGX-3400 BIOLOGICAL

Plasmid DNA delivered via IM injection with electroporation

0.6mg DNA/dose; 2mg DNA/dose; 6mg DNA/dose

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• GeneOne Life Science, Inc.: lead
• Inovio Pharmaceuticals: collaborator

Study Sites (2)

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Bird Diseases; Animal Diseases

Study Officials

• Minja Kim

  Korea Univ. MC

  PRINCIPAL INVESTIGATOR

• Minsoo Park

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 19, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

KR (2)