HSV-2Phase 1NCT00274300
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
A Phase 1 study testing pPJV7630 administered by PMED in people with HSV-2, run by PowderMed at 2 sites 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 and evaluate the effect it has on herpes outbreaks Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HSV-2
- What is being tested?
- pPJV7630 administered by PMED
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Jul 2005
- 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
- No healthy volunteers
- Adult
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Clinical Studies
Houston, Texas, 77058
Westover Heights Clinic
Portland, Oregon, 97210
About this study
Official title: A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2
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 and evaluate the effect it has on herpes outbreaks
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 the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )
- Conditions
- HSV-2
- Being tested
- pPJV7630 administered by PMED
- Keywords
- DNA vaccine, immunotherapy, Herpes Simplex Virus Type 2 (HSV2), Particle Mediated Epidermal Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pPJV7630 administered by PMEDBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events at all visits
vaccine site evaluations
laboratory parameters pre and post vaccination
Secondary outcomes (2)
HSV recurrences post vaccination
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 posted10 Jan 2006 (estimated)
- Study startAug 2004
- Study completionJul 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- PowderMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Larry Stanberry, MD, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274300
- Sponsor's protocol ID
- PJ HSV-001
- Status last verified
- Jan 2006
- First submitted
- 9 Jan 2006
- Last updated
- 29 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2
- ClinicalTrials.gov ID
- NCT00274300
- Acronym / sponsor ID
- PJ HSV-001
- Conditions
- HSV-2
- Keywords
- DNA vaccine, immunotherapy, Herpes Simplex Virus Type 2 (HSV2), Particle Mediated Epidermal Delivery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- PowderMedIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Jul 2005
- First posted
- 10 Jan 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 and evaluate the effect it has on herpes outbreaks
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 the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not 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 administered by PMED | Biological | – |
Primary outcome
Adverse Events at all visits
vaccine site evaluations
laboratory parameters pre and post vaccination
2 secondary outcomes
HSV recurrences post vaccination
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 29 Jan 2007.
Related trials for HSV-2
Not yet recruitingPhase 2
Study to Compare GS-1179 Versus Valacyclovir in HSV-2 Seropositive Participants With Recurrent Genital Herpes
HSV-2 Infection
Not yet recruitingPhase 4
Aciclovir Versus Placebo for HSV-2 Meningitis
Herpes Simplex 2, Meningitis, Viral
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
Not yet recruitingPhase 4
A Study of QL1706 Combined With OH2 Injection in Perioperative Treatment of Stage III Resectable Acral Melanoma
Melanoma, Acral Melanoma
Enrolling by invitationPhase 1
A Phase I Study to Evaluate the Safety, Tolerability, and Immunogenicity of an mRNA Vaccine Against Herpes Simplex Virus Type 2 (HSV-2) Post-Vaccination
Genital Herpes
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.
Larry Stanberry, MD, PhD principal investigator
University of Texas
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 pPJV7630 administered by PMED in people with HSV-2, run by PowderMed 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?
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 29 Jan 2007. 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?
Adverse Events at all visits. The study lists 3 primary outcomes in all. 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 29 Jan 2007.