Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults

NCT01142362 | Completed Phase 1

• 1 other identifier: FLU-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to 30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and immunogenic.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

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

  Day 0 through Month 12

Secondary Outcomes (1)

• Humoral and cellular immune responses

  Day 0 through Month 12

Study Arms (3)

0.6mg of DNA/dose

EXPERIMENTAL

Subjects will receive a 2 dose series of VGX-3400X containing 0.6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1

Biological: VGX-3400X

2mg DNA/dose

EXPERIMENTAL

Subjects will receive a 2 dose series of VGX-3400X containing 2mg of DNA/dose administered via IM injection + electroporation at Day 0 and Month 1

Biological: VGX-3400X

6mg DNA/dose

EXPERIMENTAL

Subjects will receive a 2 dose series of VGX-3400X containing 6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1

Biological: VGX-3400X

Interventions

VGX-3400X BIOLOGICAL

DNA plasmids delivered via IM injection + electroporation using CELLECTRA device

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• 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);
• Adults of either gender 18-50 years of age;
• Healthy subjects as judged by the Investigator;
• Current nonsmoker;
• Body mass index (BMI) ≤30 kg/m\^2
• Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception or have a partner who is sterile for the duration of the study (7 months);
• Able and willing to comply with all study procedures.

You may not qualify if:

• Positive serological test for HIV, hepatitis C virus or hepatitis B virus surface antigen (HBsAg);
• Pregnant or breastfeeding subjects;
• Any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site or the use of immunosuppressive agents. All other corticosteroids must be discontinued \> 4 weeks prior to Day 0 of study vaccine administration;
• Administration of any blood product within 3 months of enrollment;
• Prior receipt of an H5N1 influenza vaccine at any time;
• Subjects with a contraindication to influenza vaccination other than egg allergy (such as Guillain-Barre Syndrome after receiving influenza vaccination);
• Administration of any vaccine within 6 weeks of enrollment;
• Subject is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent;
• Subjects with cardiac pre-excitation syndromes (such as Wolff-Parkinson- White);
• Subjects with a history of seizures (unless seizure free for 5 years);
• Subjects with tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination/EP;
• Subjects with any implantable leads;
• Active drug or alcohol use or dependence;
• Prisoners or subjects who are compulsorily detained;
• Any other conditions judged by the investigator that would limit the evaluation of a subject.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (2)

Vince & Associates

Overland Park, Kansas, 66212, United States

Location

Accelovance

Rockville, Maryland, 20850, United States

Location

Related Links

• Sponsor's Website

MeSH Terms

Conditions

Influenza in Birds

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven Hull, MD

  Vince & Associates

  PRINCIPAL INVESTIGATOR

• Rita Ghosh, MD

  Accelovance

  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: May 27, 2010
• First Posted: June 11, 2010
• Study Start: June 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

US (2)