HSV-2Phase 1NCT00310271
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects
A Phase 1 study testing pPJV7630 with pPJV2012 administered by PMED in people with HSV-2, run by PowderMed at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HSV-2
- What is being tested?
- pPJV7630 with pPJV2012 administered by PMED
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Dec 2006
- 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
Otherwise healthy subjects with seronegative HSV-2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator , Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.
Read the detailed description
Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of a therapeutic DNA vaccine (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when administered by Particle Mediated Epidermal Delivery (PMED)
- Conditions
- HSV-2
- Being tested
- pPJV7630 with pPJV2012 administered by PMED
- Keywords
- DNA vaccine, immunotherapy, HSV-2, PMED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pPJV7630 with pPJV2012 administered by PMEDBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, tolerability and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit.
Secondary outcomes (1)
immunogenicity of vaccine post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startApr 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSV-2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- PowderMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Komjathy, MD, Principal investigator, PRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310271
- Sponsor's protocol ID
- PM HSD-001 P
- Status last verified
- Nov 2008
- First submitted
- 31 Mar 2006
- Last updated
- 21 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator , Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00310271
- Acronym / sponsor ID
- PM HSD-001 P
- Conditions
- HSV-2
- Keywords
- DNA vaccine, immunotherapy, HSV-2, PMED
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants
- Lead sponsor
- PowderMedIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Dec 2006
- First posted
- 3 Apr 2006 (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 evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.
Detailed description
Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of a therapeutic DNA vaccine (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when administered by Particle Mediated Epidermal Delivery (PMED)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| pPJV7630 with pPJV2012 administered by PMED | Biological | – |
Primary outcome
Safety, tolerability and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit.
1 secondary outcome
immunogenicity of vaccine post vaccination
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 21 Nov 2008.
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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 Komjathy, MD principal investigator
PRA
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 pPJV7630 with pPJV2012 administered by PMED in people with HSV-2, run by PowderMed 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?
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 21 Nov 2008. 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 and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit.. 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 21 Nov 2008.