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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01142362

Run by

Inovio Pharmaceuticals

People needed

32

Starts

2010-06-01

Expected to finish

2011-11-01

Last updated by the study team

2017-09-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Vince & Associates — Overland Park, Kansas, United States
• Accelovance — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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