Influenza, HumanPhase 1NCT01587131
DNA-based Influenza Vaccine in the Elderly
A Phase 1 study testing FVH1 - a DNA-based influenza vaccine in people with Influenza, Human and Orthomyxoviridae Infections, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections
- What is being tested?
- FVH1 - a DNA-based influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Mar 2015
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Written informed consent in accordance with institutional guidelines;
- Adults of either gender ≥ 65 years of age at entry;
- Healthy subjects, as judged by the Qualified Investigator based on medical history, physical examination, and normal results of an electrocardiogram (ECG), complete blood count (CBC), serum chemistries, and urinalysis done up to 4 weeks prior to enrollment and administration of vaccine or placebo by ID/EP;
- Current non-smoker (for 3 months prior to vaccine study);
- Willing to forego any other influenza vaccination during the study;
- Able and willing to comply with all study procedures.
Who cannot join
- 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 1 of study vaccine administration;
- Administration of any blood product within 3 months of enrollment;
- 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; subjects may not receive any licensed seasonal influenza vaccine during the study unless they have been assigned to a study group receiving the seasonal vaccine;
- 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);
Show all 12Show fewer
- 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 implanted heart leads;
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
- Prisoner 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
1 site in 1 country.
About this study
Official title: Phase I, Open Label Study of a DNA Vaccine's Ability to Increase the Immune Response to the Trivalent Seasonal Influenza Vaccine in the Elderly
The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.
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 H1N1 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 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 H1N1 influenza virus genes in the study vaccine.
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
- Being tested
- FVH1 - a DNA-based influenza vaccine
- Keywords
- Universal Influenza, Intradermal DNA-Based Vaccine, Senior, Electroporation, H1, Influenza, FVH1
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FVH1 - a DNA-based influenza vaccineBiological
0.9 mg FVH1 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Group 1- DNA prime DNA boost | Experimental | 0.9 mg of FVH1 vaccine delivered ID followed by electroporation on Day 0, Week 15 and Week 27 Receives: Biological: FVH1 - a DNA-based influenza vaccine |
| Group 2 - DNA prime Seasonal Vaccine boost | Experimental | 0.9 mg FVH1 vaccine delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15 Receives: Biological: FVH1 - a DNA-based influenza vaccine |
| Group 3 - sWFI prime Seasonal Vaccine boost | Placebo comparator | 100 microliters of sterile water for injection delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15 Receives: Biological: FVH1 - a DNA-based influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a DNA-based influenza vaccine composed of a combination of two different H1 HA plasmids administered ID followed by electroporation in healthy elderly 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 (1)
Humoral and cellular immune responses
Magnitude and frequency of antibody and cell mediated immune response 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.
- First posted27 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Inovio Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Gary Kobinger, PhD, Principal investigator, National Microbiology & University of ManitobaTrina Racine, PhD, Study director, National Microbiology Laboratory, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587131
- Sponsor's protocol ID
- B2011:131
- Status last verified
- Jan 2013
- First submitted
- 25 Apr 2012
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label Study of a DNA Vaccine's Ability to Increase the Immune Response to the Trivalent Seasonal Influenza Vaccine in the Elderly
- ClinicalTrials.gov ID
- NCT01587131
- Acronym / sponsor ID
- B2011:131
- Conditions
- Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
- Keywords
- Universal Influenza, Intradermal DNA-Based Vaccine, Senior, Electroporation, H1, Influenza, FVH1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Inovio Pharmaceuticals
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Apr 2012 (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.
The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.
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 H1N1 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 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 H1N1 influenza virus genes in the study vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1- DNA prime DNA boost | Experimental | Biological: FVH1 - a DNA-based influenza vaccine0.9 mg of FVH1 vaccine delivered ID followed by electroporation on Day 0, Week 15 and Week 27 |
| Group 2 - DNA prime Seasonal Vaccine boost | Experimental | Biological: FVH1 - a DNA-based influenza vaccine0.9 mg FVH1 vaccine delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15 |
| Group 3 - sWFI prime Seasonal Vaccine boost | Placebo comparator | Biological: FVH1 - a DNA-based influenza vaccine100 microliters of sterile water for injection delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Written informed consent in accordance with institutional guidelines;
- Adults of either gender ≥ 65 years of age at entry;
- Healthy subjects, as judged by the Qualified Investigator based on medical history, physical examination, and normal results of an electrocardiogram (ECG), complete blood count (CBC), serum chemistries, and urinalysis done up to 4 weeks prior to enrollment and administration of vaccine or placebo by ID/EP;
- Current non-smoker (for 3 months prior to vaccine study);
- Willing to forego any other influenza vaccination during the study;
Key exclusion criteria (12 listed)
- 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 1 of study vaccine administration;
- Administration of any blood product within 3 months of enrollment;
- 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; subjects may not receive any licensed seasonal influenza vaccine during the study unless they have been assigned to a study group receiving the seasonal vaccine;
- Participation in a study with an investigational compound or device within 4 weeks of signing informed consent;
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 |
|---|---|---|
| FVH1 - a DNA-based influenza vaccine0.9 mg FVH1 vaccine | Biological | Group 1- DNA prime DNA boost, Group 2 - DNA prime Seasonal Vaccine boost, Group 3 - sWFI prime Seasonal Vaccine boost |
Primary outcome
Safety and tolerability of a DNA-based influenza vaccine composed of a combination of two different H1 HA plasmids administered ID followed by electroporation in healthy elderly 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
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 17 Apr 2015.
Related trials for Influenza, Human
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
Enrolling by invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza
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.
Gary Kobinger, PhD principal investigator
National Microbiology & University of Manitoba
Trina Racine, PhD study director
National Microbiology Laboratory, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FVH1 - a DNA-based influenza vaccine in people with Influenza, Human and Orthomyxoviridae Infections, run by University of Manitoba at 1 site in Canada.
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 12 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 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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 a DNA-based influenza vaccine composed of a combination of two different H1 HA plasmids administered ID followed by electroporation in healthy elderly 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?
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 17 Apr 2015.