Status:
COMPLETED
Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults
Lead Sponsor:
Inovio Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 i...
Detailed Description
The use of DNA plasmids containing genes that express viral antigens may be a promising way to formulate a vaccine that can effectively prevent infection and disease caused by the H5N1 avian influenza...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01142362
Start Date
June 1 2010
End Date
November 1 2011
Last Update
September 13 2017
Active Locations (2)
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1
Vince & Associates
Overland Park, Kansas, United States, 66212
2
Accelovance
Rockville, Maryland, United States, 20850