Intradermal ElectroporationPhase 1NCT01324843
Safety and Tolerability of the Derma Vax(Trademark) Clinical Intradermal Electroporation System in Healthy Subjects
A Phase 1 study testing EMLA Cream, Aveeno Daily Moist and Derma Vax in people with Intradermal Electroporation, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
Background: Researchers are investigating the use of DNA vaccines to treat various types of cancer by provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal vaccines given to prevent infectious diseases, but they have been less effective than anticipated in humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Intradermal Electroporation
- What is being tested?
- EMLA Cream, Aveeno Daily Moist and Derma Vax
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2009to 27 May 2010
- 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
- Female and male subjects, age 18 to 55 and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Body mass index (BMI) must be within the range of 18 to 30 kg/m(2), inclusive
- Vital signs should be within the following ranges at screening and baseline:
- Oral body temperature between 35.0-37.5 degree C
- Systolic blood pressure, 85-140 mm Hg
- Diastolic blood pressure, 50-90 mm Hg
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- Pulse rate, 50 - 100 bpm
- Ability to provide an informed consent.
- Blood tests demonstrating normal physiologic organ functions:
- Hematological (neutrophils greater than or equal to 1000; hemoglobin greater than or equal to 12 g/dl (female) and greater than or equal to 14g/dl (male); platelets > 150,000).
- Creatinine (Cre < 1.5 times ULN)
- LFTs (SGOT, SGPT, < 2.5 times ULN)
- PT and/or PTT < 1.5 times ULN
Who cannot join
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Significant illness within two weeks prior to dosing.
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
- History of chronic skin disease that might interfere with IDEP application
- Known allergic reactions to adhesive tape
- History of use of chronic or current pain medication (narcotics)
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- Sunburn or tattoos at the application sites (both shoulders)
- Subject has a pacemaker or implanted defibrillator
- A past medical history of clinically significant EKG abnormalities or a family history (grandparents, parents and siblings) of a sudden cardiac death or dysrhythmia.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- History of HIV or hepatitis B or C.
- Pregnancy
- Known allergy to local anesthetics such as lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Aging, Harbor Hospital
Baltimore, Maryland, 21224
About this study
Official title: Safety and Tolerability of the Derma Vax Clinical Intradermal Electroporation System in Healthy Subjects
Background:
- Researchers are investigating the use of DNA vaccines to treat various types of cancer by provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal vaccines given to prevent infectious diseases, but they have been less effective than anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are studying alternate delivery methods, such as the investigational Derma Vax(Trademark) injection system that delivers the vaccine into the skin. However, because the Derma Vax(Trademark) system has not been studied in humans, more research is needed to determine whether this new vaccine delivery method is safe and tolerable, particularly in terms of pain levels and skin reactions.
Read more
Objectives:
- To evaluate the safety, effectiveness, and relative pain levels of intradermal electroporation using Derma Vax(Trademark) administered after pretreatment with either a topical cream anesthetic or placebo cream.
Eligibility:
- Healthy individuals between 18 and 55 years of age.
Design:
- Participants will be screened with a medical history, physical examination, blood and urine tests, and an electrocardiogram.
- Participants will have two different creams applied to their upper arms: one cream will be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion. Each arm will receive a different cream.
- Once the cream has taken effect, participants will receive Derma Vax(Trademark) treatment. No actual medication will be given during the injection; participants will evaluate their reaction based on the pressure and needle stick alone.
- Immediately after the treatment, participants will use the Visual Analogue Scale of pain intensity to provide a description of the level of pain experienced during the injection.
- Participants will complete additional questionnaires about pain intensity and will have the injected skin site inspected to determine possible reactions to the injection. They will also be asked their opinions on whether (based on pain levels) a series of Derma Vax(Trademark) treatments would be acceptable for treatment of a serious illness.
- The day after the injection, participants will return for an additional skin assessment of the treated areas.
Read the detailed description
Objectives:
Our primary objectives are: to assess safety and tolerability of Intradermal electroporation (IDEP) using Derma Vax(Trademark) administered after pretreatment with either EMLA(Registered Trademark) cream as topical anesthetic or with placebo and to determine if the EMLA(Registered Trademark) cream applied to the electroporation site significantly decreases pain associated with the IDEP procedure. Our secondary objectives are: to determine the magnitude of pain perception of IDEP; to determine the quality of pain perception during IDEP using a Visual Analog Scale and the McGill pain scale; to determine the time course after IDEP of Pain rating and skin irritation and to determine variations in skin resistance with and without EMLA(Registered Trademark) cream and between participants.
Experimental Design and Methods:
Twelve healthy men or women will be recruited for this study. This is a randomized double-blind, placebo-controlled study with a medical device. Each subject will receive EMLA(Registered Trademark) cream or control cream placed on the electroporation site on each deltoid area in a blinded randomized manner. This will be followed by IDEP administration to each pre-treated deltoid area.
Medical Relevance and Expected Outcome:
DNA vaccines are a promising treatment for infectious diseases and cancer. The ideal delivery method for induction of cellular and humoral immune responses has not been defined. Information from this study is necessary for future studies using Derma Vax(Trademark) in therapeutic DNA vaccine studies. Derma Vax(Trademark) is unique in its proprieties of delivering a series of electric pulses that provoke DNA uptake by antigen presenting cells that reside in the dermal layer of the skin. We expect that the application of Intradermal Electroporation (IDEP) using Derma Vax(Trademark) will be well tolerated and the use of EMLA(Registered Trademark) cream will decrease the pain compared to placebo.
- Conditions
- Intradermal Electroporation
- Being tested
- EMLA Cream, Aveeno Daily Moist, Derma Vax, Intradermal Electroporation, Visual Analogue Scale
- Keywords
- Safety and Tolerability, Intradermal Electroporation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMLA CreamDrug
Aveeno Daily MoistDrug
Derma VaxDevice
Intradermal ElectroporationProcedure or surgery
Visual Analogue ScaleProcedure or surgery
Present Pain IntensityProcedure or surgery
McGill Pain QuestionnaireProcedure or surgery
Skin AssessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability of Derma Vax
VAS with/without EMLA
Secondary outcomes (2)
McGill Questionnaire and Present Pain Intensity with/without EMLA
Time course Visual Analogue Scale (VAS) and skin irritation and skin resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study start25 Jun 2009
- Primary completion27 May 2010
- Study completion27 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intradermal ElectroporationStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324843
- Sponsor's protocol ID
- 999909249
- Other IDs
- 09-AG-N249
- Status last verified
- 20 Sep 2011
- First submitted
- 26 Mar 2011
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Lowe DB, Shearer MH, Kennedy RC. DNA vaccines: successes and limitations in cancer and infectious disease. J Cell Biochem. 2006 May 15;98(2):235-42. doi: 10.1002/jcb.20775.
PubMed 16440328Tang DC, DeVit M, Johnston SA. Genetic immunization is a simple method for eliciting an immune response. Nature. 1992 Mar 12;356(6365):152-4. doi: 10.1038/356152a0.
PubMed 1545867Srivastava IK, Liu MA. Gene vaccines. Ann Intern Med. 2003 Apr 1;138(7):550-9. doi: 10.7326/0003-4819-138-7-200304010-00011.
PubMed 12667025
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of the Derma Vax Clinical Intradermal Electroporation System in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01324843
- Acronym / sponsor ID
- 999909249
- Conditions
- Intradermal Electroporation
- Keywords
- Safety and Tolerability, Intradermal Electroporation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 25 Jun 2009
- Primary completion
- 27 May 2010 (actual)
- Study completion
- 27 May 2010 (actual)
- First posted
- 29 Mar 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.
Background:
- Researchers are investigating the use of DNA vaccines to treat various types of cancer by provoking an immune system response to tumor cells. DNA vaccines mimic the effect of normal vaccines given to prevent infectious diseases, but they have been less effective than anticipated in humans. To improve the effectiveness of DNA vaccines, researchers are studying alternate delivery methods, such as the investigational Derma Vax(Trademark) injection system that delivers the vaccine into the skin. However, because the Derma Vax(Trademark) system has not been studied in humans, more research is needed to determine whether this new vaccine delivery method is safe and tolerable, particularly in terms of pain levels and skin reactions.
Objectives:
- To evaluate the safety, effectiveness, and relative pain levels of intradermal electroporation using Derma Vax(Trademark) administered after pretreatment with either a topical cream anesthetic or placebo cream.
Eligibility:
- Healthy individuals between 18 and 55 years of age.
Design:
- Participants will be screened with a medical history, physical examination, blood and urine tests, and an electrocardiogram.
- Participants will have two different creams applied to their upper arms: one cream will be an anesthetic (lidocaine and prilocaine) and the other will be a placebo lotion. Each arm will receive a different cream.
- Once the cream has taken effect, participants will receive Derma Vax(Trademark) treatment. No actual medication will be given during the injection; participants will evaluate their reaction based on the pressure and needle stick alone.
- Immediately after the treatment, participants will use the Visual Analogue Scale of pain intensity to provide a description of the level of pain experienced during the injection.
- Participants will complete additional questionnaires about pain intensity and will have the injected skin site inspected to determine possible reactions to the injection. They will also be asked their opinions on whether (based on pain levels) a series of Derma Vax(Trademark) treatments would be acceptable for treatment of a serious illness.
- The day after the injection, participants will return for an additional skin assessment of the treated areas.
Detailed description
Objectives:
Our primary objectives are: to assess safety and tolerability of Intradermal electroporation (IDEP) using Derma Vax(Trademark) administered after pretreatment with either EMLA(Registered Trademark) cream as topical anesthetic or with placebo and to determine if the EMLA(Registered Trademark) cream applied to the electroporation site significantly decreases pain associated with the IDEP procedure. Our secondary objectives are: to determine the magnitude of pain perception of IDEP; to determine the quality of pain perception during IDEP using a Visual Analog Scale and the McGill pain scale; to determine the time course after IDEP of Pain rating and skin irritation and to determine variations in skin resistance with and without EMLA(Registered Trademark) cream and between participants.
Experimental Design and Methods:
Twelve healthy men or women will be recruited for this study. This is a randomized double-blind, placebo-controlled study with a medical device. Each subject will receive EMLA(Registered Trademark) cream or control cream placed on the electroporation site on each deltoid area in a blinded randomized manner. This will be followed by IDEP administration to each pre-treated deltoid area.
Medical Relevance and Expected Outcome:
DNA vaccines are a promising treatment for infectious diseases and cancer. The ideal delivery method for induction of cellular and humoral immune responses has not been defined. Information from this study is necessary for future studies using Derma Vax(Trademark) in therapeutic DNA vaccine studies. Derma Vax(Trademark) is unique in its proprieties of delivering a series of electric pulses that provoke DNA uptake by antigen presenting cells that reside in the dermal layer of the skin. We expect that the application of Intradermal Electroporation (IDEP) using Derma Vax(Trademark) will be well tolerated and the use of EMLA(Registered Trademark) cream will decrease the pain compared to placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Female and male subjects, age 18 to 55 and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Body mass index (BMI) must be within the range of 18 to 30 kg/m(2), inclusive
- Vital signs should be within the following ranges at screening and baseline:
- Ability to provide an informed consent.
- Blood tests demonstrating normal physiologic organ functions:
Key exclusion criteria (14 listed)
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
- Significant illness within two weeks prior to dosing.
- History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
- History of chronic skin disease that might interfere with IDEP application
- Known allergic reactions to adhesive tape
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 |
|---|---|---|
| EMLA Cream | Drug | – |
| Aveeno Daily Moist | Drug | – |
| Derma Vax | Device | – |
| Intradermal Electroporation | Procedure or surgery | – |
| Visual Analogue Scale | Procedure or surgery | – |
| Present Pain Intensity | Procedure or surgery | – |
| McGill Pain Questionnaire | Procedure or surgery | – |
| Skin Assessment | Procedure or surgery | – |
Primary outcome
Safety & Tolerability of Derma Vax
VAS with/without EMLA
2 secondary outcomes
McGill Questionnaire and Present Pain Intensity with/without EMLA
Time course Visual Analogue Scale (VAS) and skin irritation and skin resistance
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 2 Jul 2017.
- Background: PubMed 16440328Lowe DB, Shearer MH, Kennedy RC. DNA vaccines: successes and limitations in cancer and infectious disease. J Cell Biochem. 2006 May 15;98(2):235-42. doi: 10.1002/jcb.20775.
- Background: PubMed 1545867Tang DC, DeVit M, Johnston SA. Genetic immunization is a simple method for eliciting an immune response. Nature. 1992 Mar 12;356(6365):152-4. doi: 10.1038/356152a0.
- Background: PubMed 12667025Srivastava IK, Liu MA. Gene vaccines. Ann Intern Med. 2003 Apr 1;138(7):550-9. doi: 10.7326/0003-4819-138-7-200304010-00011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 EMLA Cream, Aveeno Daily Moist and Derma Vax in people with Intradermal Electroporation, run by National Institute on Aging (NIA) at 1 site 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 13 inclusion and 14 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 2 Jul 2017. 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 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 & Tolerability of Derma Vax. The study lists 2 primary outcomes in all. 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 NCT01324843, which also lists 3 linked publications.
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 2 Jul 2017.