HealthyPhase 1NCT01405885

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

A Phase 1 study testing INO-3605, INO-3609 and INO-3401 in people with Healthy, run by Inovio Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: INO-3605, INO-3609 and INO-3401
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: 3 sitesUnited States
Study dates: May 2011to Aug 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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);

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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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

SNBL
Baltimore, Maryland, 21201
Miami Research Associates
Miami, Florida, 33143
Vince and Associates
Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: Phase I, Open Label Study to Evaluate Safety, Tolerability and Immunogenicity of Multiple Combinations of H1 and H5 Influenza Hemagglutinin Plasmids Administered ID Followed by in Vivo Electroporation With CELLECTRA®-3P in Healthy Adults

Read the 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 and H1N1 influenza viruses. 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 and H1N1 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. ID injection of a 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 and H1N1 influenza virus genes in the study vaccines.

Conditions: Healthy
Being tested: INO-3605, INO-3609, INO-3401, INO-3605 AND INO-3609, INO-3510
Keywords: Universal Influenza, Intradermal DNA vaccine, Electroporation, H1 and H5, DNA Vaccination, Influenza, INO-3510
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INO-3605Biological
0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3609Biological
0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3401Biological
0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
INO-3609Biological
0.3mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
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.
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.
INO-3609Biological
0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 16 and 24.
INO-3609Biological
0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0 and Week 8
Seasonal Influenza vaccineBiological
0.5ml of vaccine delivered IM
INO-3609Biological
1.8mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.

Study groups in NCT01405885
Study group	Role	What they receive
Arm A - 0.9mg of INO-3605	Experimental	Not described Receives: Biological: INO-3605
Arm B - 0.9mg of INO-3609	Experimental	Not described Receives: Biological: INO-3609
Arm C- 0.9mg of INO-3401	Experimental	Not described Receives: Biological: INO-3401
Arm D- 0.3mg of INO-3609	Experimental	Not described Receives: Biological: INO-3609
Arm E - 0.45mg each INO-3605 , INO-3609	Experimental	Not described Receives: Biological: INO-3605 AND INO-3609
Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609	Experimental	Not described Receives: Biological: INO-3510
Arm G - 0.9mg of INO-3609	Experimental	Not described Receives: Biological: INO-3609
Arm H - 0.9mg of INO-3609	Experimental	Not described Receives: Biological: INO-3609
Arm I - Seasonal influenza vaccine	Active comparator	Not described Receives: Biological: Seasonal Influenza vaccine
Arm J - 1.8mg of INO-3609	Experimental	Not described Receives: Biological: INO-3609

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 0 through Month 12

Secondary outcomes (2)

Humoral and cellular immune responses
Magnitude and frequency of antibody and cell mediated immune response to influenza proteins
Measured: 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
Measured: Day 0 through Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Aug 2013

First posted29 Jul 2011 (estimated)
Study startMay 2011
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01405885
Sponsor's protocol ID: FLU-101
Status last verified: Feb 2014
First submitted: 27 Jul 2011
Last updated: 3 Mar 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open Label Study to Evaluate Safety, Tolerability and Immunogenicity of Multiple Combinations of H1 and H5 Influenza Hemagglutinin Plasmids Administered ID Followed by in Vivo Electroporation With CELLECTRA®-3P in Healthy Adults
ClinicalTrials.gov ID: NCT01405885
Acronym / sponsor ID: FLU-101
Conditions: Healthy
Keywords: Universal Influenza, Intradermal DNA vaccine, Electroporation, H1 and H5, DNA Vaccination, Influenza, INO-3510
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 29 Jul 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The use of EP via the CELLECTRA® device should increase the expression of H5N1 and H1N1 influenza virus genes in the study vaccines.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 10

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (15 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INO-36050.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm A - 0.9mg of INO-3605
INO-36090.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm B - 0.9mg of INO-3609
INO-34010.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm C- 0.9mg of INO-3401
INO-36090.3mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm D- 0.3mg of INO-3609
INO-3605 AND INO-36090.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm E - 0.45mg each INO-3605 , INO-3609
INO-35100.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609
INO-36090.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 16 and 24.	Biological	Arm G - 0.9mg of INO-3609
INO-36090.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0 and Week 8	Biological	Arm H - 0.9mg of INO-3609
Seasonal Influenza vaccine0.5ml of vaccine delivered IM	Biological	Arm I - Seasonal influenza vaccine
INO-36091.8mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.	Biological	Arm J - 1.8mg of INO-3609

Primary outcome

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
Time frame: Day 0 through Month 12
Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

2 secondary outcomes

Humoral and cellular immune responses
Time frame: 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
Time frame: Day 0 through Month 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
Sponsor's addressLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Bagarazzi, M.D. study director

Inovio Pharmaceuticals

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INO-3605, INO-3609 and INO-3401 in people with Healthy, run by Inovio Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Day 0 through Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014.