HIV InfectionPhase 1NCT00775424
PENNVAX-B With or Without IL-12 or IL-15 as a DNA Vaccine for HIV Infection
A Phase 1 study testing PENNVAX-B, GENEVAX IL-12-4532 and IL-15 adjuvant in people with HIV Infection, run by University of Pennsylvania at 1 site in United States.
Trial summary
A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15. Primary objectives 1. To determine the safety of HIV-1 DNA constructs (PENNVAX-B). 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infection
- What is being tested?
- PENNVAX-B, GENEVAX IL-12-4532 and IL-15 adjuvant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-1 infection documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, or plasma HIV-1 RNA, at any time before study entry.
- Taking a stable HAART regimen for ≥3 months before the time of enrollment.
- CD4-positive lymphocyte count ≥400 cells/µl on two occasions within 60 days of enrollment, performed at any certified flow laboratory.
- HIV-1 < 75 copies/mL on two occasions within 60 days of enrollment, performed in a CLIA certified laboratory.
- Laboratory values obtained within 30 days prior to study entry:
- Hemoglobin > 9 g/dL (female subjects) and > 9.5 g/dL (male subjects)
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- 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 ≥ upper limit of normal (ULN).
- All women of reproductive potential (who have not reached menopause nor undergone hysterectomy, oophorectomy, or tubal ligation) must have a negative pregnancy test within 30 days of initiating study-specified medication(s) and at day 0 (enrollment).
- Women who are not of reproductive potential (have reached menopause or undergone hysterectomy, oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with resultant azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Documentation of menopause, sterilization (hysterectomy, oophorectomy, tubal ligation, or vasectomy) and azoospermia by patient-reported history is acceptable.
- All subjects must not participate in a conception process (i.e. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must use a form of contraception while receiving protocol-specified medication(s)/vaccinations and for one month after stopping the vaccinations.
- Karnofsky performance score ≥ 90 within 30 days prior to study entry.
- Men or women ≥18 years of age and less than 50.
- 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.
- Subjects with a history of a CD4+ T-cell count ≤200/µl are not eligible.
- Use of any known immunomodulatory therapy within 4 weeks prior to study entry including but not limited to drugs such as systemic corticosteroids, interferons, interleukins, thalidomide, granulocyte-macrophage colony-stimulating factor, IV gammaglobulin, or human growth hormone.
- Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed.
- Pregnancy or breast-feeding.
- Uncontrolled diabetes mellitus (fasting blood glucose > 126 mg/dL or random blood glucose levels > 200 mg/dL on at least two occasions within 6 months prior to study entry).
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- 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 that in the opinion of the principal investigator would affect the subject's study compliance or safety.
- 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.
- History or evidence of autoimmune disease, including, but not limited to thyroid autoimmune disease and idiopathic thrombocytopenic purpura.
- Allergies to bupivacaine or similar anesthetic.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania. Clinical Trials Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: A PHASE Ib PARTIALLY RANDOMIZED PILOT STUDY INTENDED TO EVALUATE THE SAFETY AND IMMUNOLOGICAL EFFECTS OF HIV-1 DNA IMMUNIZATION (PENNVAX-B) WITH OR WITHOUT CO-ADMINISTRATION OF CONSTRUCTS CONTAINING DNA ENCODING FOR THE EXPRESSION OF EITHER IL-12 OR IL-15 IN HIV INFECTED INDIVIDUALS
A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15.
Primary objectives
- To determine the safety of HIV-1 DNA constructs (PENNVAX-B).
- To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs when given with PENNVAX-B.
Secondary objectives
- To compare the various vaccine groups for their immunological responses to several HIV-1 antigens, utilizing the ELISPOT assay.
- To analyze antibody responses to the vaccine antigens over time.
- To measure CD8 cell proliferative responses to vaccine antigens over time.
- Conditions
- HIV Infection
- Being tested
- PENNVAX-B, GENEVAX IL-12-4532, PLACEBO, IL-15 adjuvant
- Keywords
- HIV infection, DNA vaccine, IL-12 adjuvant, IL-15 adjuvant
- 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
PENNVAX-B is a cocktail of three expression plasmids. The plasmids include the genes which encode a synthetic HIV-1 envelope protein (pEY2E1-B), Gag (gagCAM02), and Pol (pK2C1). Each plasmid is manufactured to a concentration of 4.0 mg/mL and is formulated with bupivacaine (0.25%) as a facilitating agent for DNA uptake. All plasmids (2.0 mg each gag, pol, env) are premixed by the manufacturer in the same vial.
GENEVAX IL-12-4532Biological
GENEVAX IL-12-4532 This molecular adjuvant plasmid contains nucleotide sequences necessary for expression of the human IL-12 protein. IL-12 DNA is formulated at a concentration of 2.0 mg/mL with bupivacaine (0.25%).
PLACEBOBiological
PLACEBO
IL-15 adjuvantBiological
pIL15EAM is a plasmid that encodes human IL-15 and has been optimized to express 87 fold higher than native IL-15 DNA and 5.7 fold higher than an earlier generation optimized IL-15 DNA construct. This plasmid is formulated at a concentration of 4.0 mg/mL with bupivacaine (0.25%).
| Study group | Role | What they receive |
|---|---|---|
| PENNVAX-B alone | Experimental | PENNVAX-B alone Receives: Biological: PENNVAX-B |
| PENNVAX-B+IL12 | Experimental | PENNVAX-B+IL12 Receives: Biological: PENNVAX-B; Biological: GENEVAX IL-12-4532 |
| PENNVAX-B+IL15 | Experimental | PENNVAX-B+IL15 Receives: Biological: PENNVAX-B; Biological: IL-15 adjuvant |
| PLACEBO | Placebo comparator | PLACEBO Receives: Biological: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events in each of the treatment arms
Measured: Time of each vaccination, 2 weeks after vaccinations 3 and 4 and at the completion of the study.
Secondary outcomes (1)
Antigen specific cellular and humoral immune response.
Measured: 2 weeks following the third and fourth vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Drexel University
- Responsible party
- Sponsor
- Investigators
- Pablo Tebas, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775424
- Sponsor's protocol ID
- 807682
- Status last verified
- Aug 2016
- First submitted
- 17 Oct 2008
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE Ib PARTIALLY RANDOMIZED PILOT STUDY INTENDED TO EVALUATE THE SAFETY AND IMMUNOLOGICAL EFFECTS OF HIV-1 DNA IMMUNIZATION (PENNVAX-B) WITH OR WITHOUT CO-ADMINISTRATION OF CONSTRUCTS CONTAINING DNA ENCODING FOR THE EXPRESSION OF EITHER IL-12 OR IL-15 IN HIV INFECTED INDIVIDUALS
- ClinicalTrials.gov ID
- NCT00775424
- Acronym / sponsor ID
- 807682
- Conditions
- HIV Infection
- Keywords
- HIV infection, DNA vaccine, IL-12 adjuvant, IL-15 adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Drexel University
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Oct 2008 (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.
A phase Ib partially blinded pilot study to evaluate the safety and immunological effects of PENNVAX-B with or without co-administration of constructs containing DNA encoding for the expression of either IL-12 or IL-15.
Primary objectives
- To determine the safety of HIV-1 DNA constructs (PENNVAX-B).
- To determine the safety and optimal doses of the IL-12 and the IL-15 adjuvant constructs when given with PENNVAX-B.
Secondary objectives
- To compare the various vaccine groups for their immunological responses to several HIV-1 antigens, utilizing the ELISPOT assay.
- To analyze antibody responses to the vaccine antigens over time.
- To measure CD8 cell proliferative responses to vaccine antigens over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PENNVAX-B alone | Experimental | Biological: PENNVAX-BPENNVAX-B alone |
| PENNVAX-B+IL12 | Experimental | Biological: PENNVAX-B, Biological: GENEVAX IL-12-4532PENNVAX-B+IL12 |
| PENNVAX-B+IL15 | Experimental | Biological: PENNVAX-B, Biological: IL-15 adjuvantPENNVAX-B+IL15 |
| PLACEBO | Placebo comparator | Biological: PLACEBOPLACEBO |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- HIV-1 infection documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, or plasma HIV-1 RNA, at any time before study entry.
- Taking a stable HAART regimen for ≥3 months before the time of enrollment.
- CD4-positive lymphocyte count ≥400 cells/µl on two occasions within 60 days of enrollment, performed at any certified flow laboratory.
- HIV-1 < 75 copies/mL on two occasions within 60 days of enrollment, performed in a CLIA certified laboratory.
- Laboratory values obtained within 30 days prior to study entry:
Key exclusion criteria (14 listed)
- Any active or past AIDS-defining illness with the exception of minimal (less than 10 lesions) cutaneous Kaposi's sarcoma.
- Subjects with a history of a CD4+ T-cell count ≤200/µl are not eligible.
- Use of any known immunomodulatory therapy within 4 weeks prior to study entry including but not limited to drugs such as systemic corticosteroids, interferons, interleukins, thalidomide, granulocyte-macrophage colony-stimulating factor, IV gammaglobulin, or human growth hormone.
- Any malignancy requiring systemic or local toxic chemotherapy. Local radiation will be allowed.
- Pregnancy or breast-feeding.
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-BPENNVAX-B is a cocktail of three expression plasmids. The plasmids include the genes which encode a synthetic HIV-1 envelope protein (pEY2E1-B), Gag (gagCAM02), and Pol (pK2C1). Each plasmid is manufactured to a concentration of 4.0 mg/mL and is formulated with bupivacaine (0.25%) as a facilitating agent for DNA uptake. All plasmids (2.0 mg each gag, pol, env) are premixed by the manufacturer in the same vial. | Biological | PENNVAX-B alone, PENNVAX-B+IL12, PENNVAX-B+IL15 |
| GENEVAX IL-12-4532GENEVAX IL-12-4532 This molecular adjuvant plasmid contains nucleotide sequences necessary for expression of the human IL-12 protein. IL-12 DNA is formulated at a concentration of 2.0 mg/mL with bupivacaine (0.25%). | Biological | PENNVAX-B+IL12 |
| PLACEBOPLACEBO | Biological | PLACEBO |
| IL-15 adjuvantpIL15EAM is a plasmid that encodes human IL-15 and has been optimized to express 87 fold higher than native IL-15 DNA and 5.7 fold higher than an earlier generation optimized IL-15 DNA construct. This plasmid is formulated at a concentration of 4.0 mg/mL with bupivacaine (0.25%). | Biological | PENNVAX-B+IL15 |
Primary outcome
Frequency of adverse events in each of the treatment arms
Time frame: Time of each vaccination, 2 weeks after vaccinations 3 and 4 and at the completion of the study.
1 secondary outcome
Antigen specific cellular and humoral immune response.
Time frame: 2 weeks following the third and fourth vaccinations
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 25 Aug 2016.
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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, GENEVAX IL-12-4532 and IL-15 adjuvant in people with HIV Infection, run by University of Pennsylvania 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 17 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 25 Aug 2016. 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. 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?
Frequency of adverse events in each of the treatment arms (time frame: Time of each vaccination, 2 weeks after vaccinations 3 and 4 and at the completion of the study.). 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 25 Aug 2016.