HealthyPhase 1NCT01142362

Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults

A Phase 1 study testing VGX-3400X in people with Healthy, run by Inovio Pharmaceuticals at 2 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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: VGX-3400X
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: Jun 2010to Nov 2011
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 50 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 18-50 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.

Who cannot join

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);

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Vince & Associates
Overland Park, Kansas, 66212
Accelovance
Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: Phase I, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity in Healthy Adults of a DNA Plasmid Vaccine for H5 Avian Influenza (VGX-3400X) Administered by Intramuscular (IM) Injection Followed by Electroporation (EP)

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, VGX-3400X, 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 30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and immunogenic.

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. 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. IM 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 VGX-3400X DNA vaccine.

Conditions: Healthy
Being tested: VGX-3400X
Keywords: H5N1, Avian Influenza, DNA Vaccine, Intramuscular (IM) Injection, Electroporation, Healthy Adults
Medical subject headings: Influenza in Birds

What participants receive

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

VGX-3400XBiological
DNA plasmids delivered via IM injection + electroporation using CELLECTRA device

Study groups in NCT01142362
Study group	Role	What they receive
0.6mg of DNA/dose	Experimental	Subjects will receive a 2 dose series of VGX-3400X containing 0.6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 Receives: Biological: VGX-3400X
2mg DNA/dose	Experimental	Subjects will receive a 2 dose series of VGX-3400X containing 2mg of DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 Receives: Biological: VGX-3400X
6mg DNA/dose	Experimental	Subjects will receive a 2 dose series of VGX-3400X containing 6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 Receives: Biological: VGX-3400X

What is being measured

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

Safety and tolerability
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 (1)

Humoral and cellular immune responses
Magnitude and frequency of antibody and cell-mediated immune responses to influenza proteins.
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.

Jun 2010Nov 2011

First posted11 Jun 2010 (estimated)
Study startJun 2010
Primary completionNov 2011
Study completionNov 2011

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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01142362
Sponsor's protocol ID: FLU-001
Status last verified: Sep 2017
First submitted: 27 May 2010
Last updated: 13 Sep 2017
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity in Healthy Adults of a DNA Plasmid Vaccine for H5 Avian Influenza (VGX-3400X) Administered by Intramuscular (IM) Injection Followed by Electroporation (EP)
ClinicalTrials.gov ID: NCT01142362
Acronym / sponsor ID: FLU-001
Conditions: Healthy
Keywords: H5N1, Avian Influenza, DNA Vaccine, Intramuscular (IM) Injection, Electroporation, Healthy Adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 11 Jun 2010 (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 influenza virus genes in the VGX-3400X DNA vaccine.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
0.6mg of DNA/dose	Experimental	Biological: VGX-3400XSubjects will receive a 2 dose series of VGX-3400X containing 0.6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1
2mg DNA/dose	Experimental	Biological: VGX-3400XSubjects will receive a 2 dose series of VGX-3400X containing 2mg of DNA/dose administered via IM injection + electroporation at Day 0 and Month 1
6mg DNA/dose	Experimental	Biological: VGX-3400XSubjects will receive a 2 dose series of VGX-3400X containing 6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 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 18-50 years of age;
Healthy subjects as judged by the Investigator;
Current nonsmoker;
Body mass index (BMI) ≤30 kg/m^2

Key exclusion criteria (15 listed)

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;

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
VGX-3400XDNA plasmids delivered via IM injection + electroporation using CELLECTRA device	Biological	0.6mg of DNA/dose, 2mg DNA/dose, 6mg DNA/dose

Primary outcome

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

1 secondary outcome

Humoral and cellular immune responses
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 13 Sep 2017.
Sponsor's WebsiteLink 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.

Steven Hull, MD principal investigator

Vince & Associates

Rita Ghosh, MD principal investigator

Accelovance

2 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 VGX-3400X in people with Healthy, run by Inovio Pharmaceuticals at 2 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 7 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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 (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 NCT01142362.

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 13 Sep 2017.