NCT01405885

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2011

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

July 27, 2011

Last Update Submit

February 28, 2014

Conditions

Healthy

Keywords

Universal InfluenzaIntradermal DNA vaccineElectroporationH1 and H5DNA VaccinationInfluenzaINO-3510

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of nine different formulation of multiple combination of H1 and H5 HA plasmid administered ID followed by electroporation in healthy adult subjects

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

    Day 0 through Month 12

Secondary Outcomes (2)

  • Humoral and cellular immune responses

    Day 0 through Month 12

  • tolerability and immunogenicity of multiple formulations of H1 and H5 HA plasmids administered ID followed by electroporation to seasonal influenza vaccine

    Day 0 through Month 12

Study Arms (10)

Arm A - 0.9mg of INO-3605

EXPERIMENTAL
Biological: INO-3605

Arm B - 0.9mg of INO-3609

EXPERIMENTAL
Biological: INO-3609

Arm C- 0.9mg of INO-3401

EXPERIMENTAL
Biological: INO-3401

Arm D- 0.3mg of INO-3609

EXPERIMENTAL
Biological: INO-3609

Arm E - 0.45mg each INO-3605 , INO-3609

EXPERIMENTAL
Biological: INO-3605 AND INO-3609

Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609

EXPERIMENTAL
Biological: INO-3510

Arm G - 0.9mg of INO-3609

EXPERIMENTAL
Biological: INO-3609

Arm H - 0.9mg of INO-3609

EXPERIMENTAL
Biological: INO-3609

Arm I - Seasonal influenza vaccine

ACTIVE COMPARATOR
Biological: Seasonal Influenza vaccine

Arm J - 1.8mg of INO-3609

EXPERIMENTAL
Biological: INO-3609

Interventions

INO-3605BIOLOGICAL

0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Arm A - 0.9mg of INO-3605
INO-3609BIOLOGICAL

0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Arm B - 0.9mg of INO-3609
INO-3401BIOLOGICAL

0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Arm C- 0.9mg of INO-3401
INO-3605 AND INO-3609BIOLOGICAL

0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Arm E - 0.45mg each INO-3605 , INO-3609
INO-3510BIOLOGICAL

0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609
Seasonal Influenza vaccineBIOLOGICAL

0.5ml of vaccine delivered IM

Arm I - Seasonal influenza vaccine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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);
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Vince and Associates

Overland Park, Kansas, 66212, United States

Location

SNBL

Baltimore, Maryland, 21201, United States

Location

Related Links

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Mark Bagarazzi, M.D.

    Inovio Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2011

First Posted

July 29, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

US(3)