A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001

NCT01403155 | Completed Phase 1

• 1 other identifier: FLU-002
• Study Type: interventional
• Target: 22
• 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, INO-3401, 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 up 30 healthy adult subjects who have participated in study FLU-001. It is hypothesized that a booster dose with INO-3401 + EP will be well tolerated and immunogenic.

Conditions

Healthy

Keywords

H5N1; Avian Influenza; DNA Vaccine; Intradermal (ID) Injection; Electroporation; Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Safety

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

  Day 0 through Month 9

Secondary Outcomes (2)

• Humoral and cellular immune responses

  Day 0 through Month 9

• Tolerability

  Day 0 and Month 3

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine) at Day o and Month 3.

Biological: INO-3401 + EP

Interventions

INO-3401 + EP BIOLOGICAL

All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine)at Day 0 and Month 3.

All subjects

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);
• Enrollment in and received at least one vaccination in study FLU-001;
• Adults of either gender 18-50 years of age at entry;
• Healthy subjects as judged by the Investigator based on medical history, physical examination, and negative pregnancy test for Women of child-bearing potential (WOCBP) prior to enrollment and administration of study drug;
• Current nonsmoker;
• 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) through Month 4 of the study;
• Able and willing to comply with all study procedures.

You may not qualify if:

• Subjects with grade 3 or 4 CPK elevation;
• 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 an H5N1 influenza vaccine at any time;
• Subjects with a contraindications to influenza vaccination other than egg allergy (such as a history of Guillain-Barre Syndrome after receiving influenza vaccine);
• Administration of any vaccine other than VGX-3400X within 6 weeks of enrollment;
• Subject is currently participating or has participated in a study with an investigational compound other than FLU-001 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 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.

Sponsors & Collaborators

• Inovio Pharmaceuticals: lead

Study Sites (2)

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Location

Accelovance

Rockville, Maryland, 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

• Mark Bagarazzi, MD

  Inovio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

US (2)