A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus

Completed · Phase 1

Conditions studied: Healthy

In brief

This is a Phase I, parallel design open label study to evaluate safety, tolerability and immunogenicity of nine different formulation of two individual H1 and one H5 HA plasmid administered intradermally followed by electroporation in healthy adults

Key facts

Study ID

NCT01405885

Run by

Inovio Pharmaceuticals

People needed

116

Starts

2011-05-01

Expected to finish

2013-08-01

Last updated by the study team

2014-03-03

Who can join

Age: 18 and older, up to 55. 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 18-55 years of age at entry;
• Healthy subjects as judged by the Investigator based on medical history, physical examination, and normal results for an ECG, CBC, serum chemistries, and urinalysis done up to 4 weeks prior to enrollment and administration of vaccination ± EP;
• Current nonsmoker;
• Women of child-bearing potential (WOCBP) agree to remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc), or have a partner who is sterile (i.e., vasectomy) until 12 weeks after last vaccination;
• Able and willing to comply with all study procedures.

You may not qualify if…

• Positive serological test for Human Immunodeficiency Virus, hepatitis C virus or hepatitis B virus surface antigen (HBsAg) or Grade 3 or greater CPK at screening;
• Pregnant or breastfeeding subjects;
• Any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site (excluding inhaled and eye drop-containing corticosteroids) or the use of other 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 any investigational or licensed H5N1 influenza vaccine at any time;
• Subjects with contraindications to influenza vaccination other than egg allergy (such as a history of Guillain-Barre Syndrome after receiving influenza vaccine);
• Administration of any vaccine within 6 weeks of enrollment;
• Participation in a study with an investigational compound or device within 4 weeks 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 that, in the opinion of the investigator, would interfere with adherence to study requirements;
• 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.

Where it is running

• Miami Research Associates — Miami, Florida, United States
• Vince and Associates — Overland Park, Kansas, United States
• SNBL — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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