search
Back to results

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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
INO-3401 + EP
Sponsored by
Inovio Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring H5N1, Avian Influenza, DNA Vaccine, Intradermal (ID) Injection, Electroporation, Healthy Adults

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Vince and Associates Clinical Research
  • Accelovance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Humoral and cellular immune responses
Magnitude and frequency of antibody and cell-mediated immune responses to influenza proteins.
Tolerability
Tolerability by Visual Analog Scale (VAS)

Full Information

First Posted
July 25, 2011
Last Updated
September 11, 2017
Sponsor
Inovio Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01403155
Brief Title
A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001
Official Title
PHASE I, OPEN-LABEL, SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF AN H5 INFLUENZA PLASMID VACCINE (INO-3401) IN HEALTHY ADULTS PREVIOUSLY VACCINATED WITH VGX-3400X
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inovio Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 virus. Plasmid vectors are simple to construct and are easy to manufacture at a relatively low cost. Vaccination with plasmids that express influenza proteins should induce the development of serum antibodies and might also induce significant quantities of secretory IgA antibodies and/or CMI. The DNA sequences included in the vaccine could also result in the proliferation of T lymphocytes that could broaden the effectiveness of the vaccine to include variant strains of H5N1 with antigenically modified HA (i.e., drifted strains). Electroporation (EP) is a technology in which a transmembrane electrical field is applied to increase the permeability of cell membranes to create microscopic pathways (pores) and thereby enhance the uptake of drugs, vaccines, or other agents into target cells. Their presence allows macromolecules, ions, and water to pass from one side of the membrane to the other. The presence of a constant field influences the kinetics of directional translocation of the macromolecular plasmid, such that the plasmid delivery in vivo has been sufficient to achieve physiological levels of secreted proteins. Intradermal (ID) injection of plasmid followed by EP has been used very successfully to deliver therapeutic genes that encode for a variety of hormones, cytokines, or enzymes in a variety of species. EP is currently being used in humans to deliver cancer vaccines and therapeutics as well as in gene therapy. The expression levels are increased by as much as 3 orders of magnitude over plasmid injection alone. The use of EP via the CELLECTRA® device should increase the expression of H5N1 influenza virus genes in the INO-3401 DNA vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
H5N1, Avian Influenza, DNA Vaccine, Intradermal (ID) Injection, Electroporation, Healthy Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine) at Day o and Month 3.
Intervention Type
Biological
Intervention Name(s)
INO-3401 + EP
Intervention Description
All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine)at Day 0 and Month 3.
Primary Outcome Measure Information:
Title
Safety
Description
Frequency and severity of local and systemic reactogenicity, signs and symptoms, adverse events and serious adverse events.
Time Frame
Day 0 through Month 9
Secondary Outcome Measure Information:
Title
Humoral and cellular immune responses
Description
Magnitude and frequency of antibody and cell-mediated immune responses to influenza proteins.
Time Frame
Day 0 through Month 9
Title
Tolerability
Description
Tolerability by Visual Analog Scale (VAS)
Time Frame
Day 0 and Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bagarazzi, MD
Organizational Affiliation
Inovio Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Accelovance
City
Rockville
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.inovio.com
Description
Sponsor's Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs