HIV-1 InfectionPhase 1HIV-001NCT01082692
Study of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
A Phase 1 study testing PENNVAX-B in people with HIV-1 Infection and HIV Infections, run by Inovio Pharmaceuticals at 1 site in United States.
Trial summary
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. We have developed DNA vaccine, PENNVAX-B, which includes plasmids targeting the gag, pol, and env proteins of HIV-1. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV-1 Infection, HIV Infections
- What is being tested?
- PENNVAX-B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2012
- 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
Who may be able to join
- HIV-1 infection
- On a stable HAART regimen for ≥3 months before the time of enrollment
- CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment
- HIV-1 < 75 copies/mL on two occasions within 60 days of enrollment
- Body mass index (BMI) ≤30 kg/m^2
- Laboratory values obtained within 30 days prior to study entry:
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- Hemoglobin > 9 g/dL (female subjects) > 9.5 g/dL (male subjects)
- Absolute neutrophil count > 1000 cells/μL
- Platelet count > 75,000/μL
- ALT, AST and alkaline phosphatase < 2.5 x upper limit of normal range
- Total bilirubin < 2.5 x upper limit of the laboratory normal range
- Serum creatinine <1.5 mg/dL X upper limit of normal (ULN)
- Female subjects of reproductive potential must have a negative serum pregnancy test performed within 30 days of initiating the protocol-specified vaccination and a negative urine pregnancy test at Day 0 (enrollment)
- Ability and willingness of subject or legal guardian/representative to give written informed consent
Who cannot join
- Any active or past AIDS-defining illness with the exception of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma
- History of a CD4+ T-cell count ≤200/μL
- Grade 2 or higher CPK laboratory result
- Use of any known immunomodulatory therapy within 4 weeks prior to study entry
- Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed
- Pregnancy or breast-feeding
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- Uncontrolled diabetes mellitus
- Major organ transplantation
- Active alcohol or substance abuse or psychiatric illness, which in the opinion of the investigator will interfere with adherence to study requirements
- Clinically significant neurological disorder occurring within 1 year prior to study entry
- Use of systemic corticosteroids for 4 weeks within 3 months prior to study entry
- Presence of any chronic disease that in the opinion of the investigator might affect subject safety
- History of previous vaccination with an HIV-1 vaccine except where documentation of placebo is available
- History of cardiac arrhythmia
- History or evidence of autoimmune disease
- Allergies to bupivacaine or similar anesthetic
- Metal implants at the site of injection
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness
- Any other conditions judged by the investigator that would limit the evaluation of a subject
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase I, Open Label Study to Evaluate the Safety, Tolerability and Immunogenicity of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
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. We have developed DNA vaccine, PENNVAX-B, which includes plasmids targeting the gag, pol, and env proteins of HIV-1. 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 HIV-1 infected subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above 400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well tolerated.
Read the detailed description
A single group of approximately 12 HIV-infected subjects will receive a 4 dose series of PENNVAX-B containing 3 mg of DNA/dose at study entry (Day 0), Week 4, 8, 16 and will be followed for a total of 48 weeks.
- Conditions
- HIV-1 Infection, HIV Infections
- Being tested
- PENNVAX-B
- Keywords
- HIV Infection, DNA vaccine, Electroporation, HIV therapeutic vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENNVAX-BBiological
DNA plasmids delivered via IM injection + electroporation using CELLECTRA device
| Study group | Role | What they receive |
|---|---|---|
| 3mg DNA/dose | Experimental | Subjects will receive a 4 dose series of PENNVAX-B containing 3mg of DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8 and Week 16. Receives: Biological: PENNVAX-B |
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, laboratory measures of safety, including CD4 and HIV RNA viral load changes, and adverse and serious adverse events.
Measured: Day 0 through Week 48
Secondary outcomes (1)
T-cell responses
Magnitude of HIV-specific immune response as determined by ELISpot assay measured two weeks following the 4th vaccination
Measured: Day 0 through Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Tebas, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082692
- Sponsor's protocol ID
- HIV-001
- Acronym
- HIV-001
- Status last verified
- Nov 2012
- First submitted
- 5 Mar 2010
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study to Evaluate the Safety, Tolerability and Immunogenicity of PENNVAX™-B (Gag, Pol, Env) + Electroporation in HIV-1 Infected Adult Participants
- ClinicalTrials.gov ID
- NCT01082692
- Acronym / sponsor ID
- HIV-001 / HIV-001
- Conditions
- HIV-1 Infection, HIV Infections
- Keywords
- HIV Infection, DNA vaccine, Electroporation, HIV therapeutic vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Inovio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Mar 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.
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. We have developed DNA vaccine, PENNVAX-B, which includes plasmids targeting the gag, pol, and env proteins of HIV-1. 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 HIV-1 infected subjects whose viral load is undetectable on a HAART regimen, with CD4 lymphocyte count above 400 cells/µL of blood. It is hypothesized that PENNVAX-B + EP will be safe and well tolerated.
Detailed description
A single group of approximately 12 HIV-infected subjects will receive a 4 dose series of PENNVAX-B containing 3 mg of DNA/dose at study entry (Day 0), Week 4, 8, 16 and will be followed for a total of 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3mg DNA/dose | Experimental | Biological: PENNVAX-BSubjects will receive a 4 dose series of PENNVAX-B containing 3mg of DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8 and Week 16. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- HIV-1 infection
- On a stable HAART regimen for ≥3 months before the time of enrollment
- CD4-+ lymphocyte count ≥400 cells/μL on two occasions within 60 days of enrollment
- HIV-1 < 75 copies/mL on two occasions within 60 days of enrollment
- Body mass index (BMI) ≤30 kg/m^2
Key exclusion criteria (19 listed)
- Any active or past AIDS-defining illness with the exception of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma
- History of a CD4+ T-cell count ≤200/μL
- Grade 2 or higher CPK laboratory result
- Use of any known immunomodulatory therapy within 4 weeks prior to study entry
- Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed
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 |
|---|---|---|
| PENNVAX-BDNA plasmids delivered via IM injection + electroporation using CELLECTRA device | Biological | 3mg DNA/dose |
Primary outcome
Safety and tolerability
Time frame: Day 0 through Week 48
Frequency and severity of local and systemic reactogenicity signs and symptoms, laboratory measures of safety, including CD4 and HIV RNA viral load changes, and adverse and serious adverse events.
1 secondary outcome
T-cell responses
Time frame: Day 0 through Week 48
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 9 Nov 2012.
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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.
Pablo Tebas, MD principal investigator
University of Pennsylvania
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 PENNVAX-B in people with HIV-1 Infection and HIV Infections, run by Inovio Pharmaceuticals 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 14 inclusion and 19 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 9 Nov 2012. 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 and tolerability (time frame: Day 0 through Week 48). 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 9 Nov 2012.