HIV InfectionsPhase 1NCT01578889

Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults

A Phase 1 study testing HIV-MAG vaccine, IL-12 pDNA adjuvant and VSV HIV gag vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: HIV-MAG vaccine, IL-12 pDNA adjuvant and VSV HIV gag vaccine
Type of treatment: Vaccines, Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 5 sitesUnited States
Study dates: May 2012to Oct 2016
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

Who may be able to join

Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willing to be followed for the planned duration of the study
Able and willing to provide informed consent
Assessment of understanding: participant demonstrates understanding of this study and completes a questionnaire prior to the first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Willing to receive HIV test results
Willing to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study injection

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Agrees not to enroll in another study of an investigational research agent prior to completion of last required protocol clinic visit (excludes annual contacts for safety surveillance)
In good general health as shown by medical history, physical exam, and screening laboratory tests
Assessed by the clinic staff as being at "low risk" for HIV infection
Hemoglobin greater than or equal to 11.0 g/dL for participants who were born female; greater than or equal to 13.0 g/dL for participants who were born male
White blood cell (WBC) count equal to 3,300 to 12,000 cells/mm^3
Total lymphocyte count greater than or equal to 800 cells/mm^3
Remaining differential either within institutional normal range or with site physician approval
Platelets equal to 125,000 to 550,000/mm^3
Chemistry panel: ALT, AST, alkaline phosphatase, and creatinine values less than or equal to the institutional upper limits of normal; CPK less than or equal to 2.0 times the institutional upper limit of normal
Negative HIV-1 and -2 blood test: participants in the United States must have a negative Food and Drug Administration (FDA)-approved immunoassay
Negative hepatitis B surface antigen (HBsAg)
Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Normal urine:
Negative urine glucose, and
Negative or trace urine protein, and
Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis within institutional normal range)
Participants who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination
Reproductive status: A participant who was born female must agree to consistently use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit; or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation; or be sexually abstinent. More information on this criterion can be found in the protocol.
Participants who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

Who cannot join

Allergy to amide-type local anesthetics (bupivacaine [Marcaine], lidocaine [Xylocaine], mepivacaine [Polocaine/Carbocaine], etidocaine [Duranest], prilocaine [Citanest, EMLA® cream])
Presence of implanted electronic medical device (e.g., pacemaker, implantable cardioverter defibrillator)
Presence of surgical or traumatic metal implant in the upper limb and/or upper torso
Sinus bradycardia (defined as less than 50 bpm on exam) or a history of cardiac arrhythmia: e.g., supraventricular tachycardia, atrial fibrillation, or frequent ectopy
Neurological or neuropsychiatric disorder that may interfere with the assessment of safety: e.g., frequent recurring headaches (i.e., a pattern of more than one headache per month affecting activities of daily living [ADLs]/work, frequent or severe/complicated migraines, cluster headaches), a chronic pain syndrome, dizziness, history of meningitis or encephalitis, cranial/spinal/peripheral neuropathy, limb weakness or paralysis, movement disorder, narcolepsy, stroke with sequelae, moderate/severe major depressive disorder, moderate/severe bipolar disorder
Seizure disorder

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Untreated or incompletely treated syphilis infection
HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who have received control/placebo in an HIV vaccine trial, the HVTN 087 Protocol Safety Review Team (PSRT) will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA. For potential participants who have received control/placebo in an experimental vaccine trial, the HVTN 087 PSRT will determine eligibility on a case-by-case basis. For potential participants who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the PSRT on a case-by-case basis.
Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical corticosteroids for mild, uncomplicated dermatitis; or [3] oral/parenteral corticosteroids given for non-chronic conditions not expected to recur [length of therapy 10 days or less with completion at least 30 days prior to enrollment].)
Blood products received within 120 days before first vaccination
Immunoglobulin received within 60 days before first vaccination
Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
Investigational research agents received within 30 days before first vaccination
Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 087 study
Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (e.g., tetanus, pneumococcal, hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Current anti-tuberculosis (TB) prophylaxis or therapy
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the protocol.
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent
Serious adverse reactions to vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded: a participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Autoimmune disease
Immunodeficiency
Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
Hypertension:
If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these participants, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with two or more of the following: age greater than 45 years old, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, or known hyperlipidemia
Deltoid skin fold measurement by caliper greater than 40 mm
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions)
Cancer (Not excluded: a participant with a surgical excision and subsequent observation period that in the investigator's estimation has a reasonable assurance of sustained cure or is unlikely to recur during the period of the study.)
Asplenia: any condition resulting in the absence of a functional spleen
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are people with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Pregnant or breastfeeding

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee, 37232-2582
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642

Other trials in United States

About this study

Official title: A Phase 1 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an IL-12 pDNA Enhanced HIV-1 Multiantigen pDNA Vaccine Delivered Intramuscularly With Electroporation, With an HIV-1 rVSV Vaccine Boost, in Healthy HIV-Uninfected Adult Participants

Some vaccines may work better when given together with another substance known as an adjuvant or when given with an experimental procedure called electroporation (EP). EP is a method where an electric pulse is administered to the same muscle where the vaccine injection is given. The addition of the adjuvant to the vaccine and the delivery with EP may increase a person's immune response to the vaccine. Combination approaches such as a DNA vaccine followed by live vector boost may also increase a person's immune response to the vaccine components. All of these interventions will be tested in this study.

This study will evaluate the safety and tolerability of and immune response to an HIV DNA vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.

Read the detailed description

The effectiveness of a vaccine may be increased when combined with an adjuvant and/or when given with EP. The addition of an adjuvant or EP may increase a person's immune response to a vaccine. Furthermore, the immune response to HIV antigens may be improved by giving a DNA vaccine boosted with a live vector vaccine. The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV DNA vaccine (HIV-MAG) alone or in combination with an IL-12 pDNA adjuvant, delivered IM via EP followed by a Vesicular Stomatitis Virus (VSV) HIV gag vaccine boost given IM by needle and syringe in healthy, HIV-uninfected adults.

Participants will be enrolled into the study in one of four groups. Each of the four groups will receive 3 mg of the HIV-MAG vaccine alone or combined with one of three different doses of the IL-12 pDNA adjuvant, followed by the VSV HIV gag vaccine boost. Within each of the four groups, participants will be randomly assigned to receive the study vaccines or placebo. At study entry (Day 0), all participants will undergo a physical examination and blood collection. Female participants will also take a pregnancy test. Participants will complete questionnaires and receive counseling on HIV risk reduction. They will also receive their first vaccination. Participants will remain in the clinic for 30 minutes after the vaccination for observation and monitoring.

Additional vaccination study visits will occur at Months 1, 3, and 6. At Months 1 and 3, participants will receive the same vaccine or placebo they received at study entry; at Month 6, participants will receive the VSV HIV gag vaccine or placebo. For 3 days after the study entry and Months 1 and 3 vaccination visits, participants will record their symptoms in a diary. After the Month 6 vaccination visit, participants will record their symptoms for 7 days.

Participants in Groups 1 and 3 will attend additional study visits on Days 1, 3, 14, 42, 91, 98, 169, 171, 175, 182, 273, and 364. Participants in Groups 2 and 4 will attend additional study visits on Days 14, 42, 98, 182, 273, and 364. Most study visits will include a physical examination, blood collection, oral mucosa examination, interviews and questionnaires, and oral mucosa examination. If participant has any oral sores, oral swabs may be collected. Saliva also may be collected. Select study visits will include a mini mental state exam, urine collection, HIV testing, and risk reduction counseling. Study researchers will contact participants at Months 15, 24, and 36 for follow-up health monitoring.

Conditions: HIV Infections
Being tested: HIV-MAG vaccine, IL-12 pDNA adjuvant, VSV HIV gag vaccine, Placebo, Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HIV-MAG vaccineBiological
Participants assigned to receive the HIV-MAG vaccine will receive 3 mg of the vaccine with bupivacaine, alone or admixed with one of three doses of the IL-12 pDNA adjuvant.
IL-12 pDNA adjuvantBiological
Participants assigned to receive the IL-12 plasmid (IL-12 pDNA) adjuvant will receive one of three doses (total of 250 mcg, 1000 mcg, or 1500 mcg) of the adjuvant admixed with the HIV-MAG vaccine.
VSV HIV gag vaccineBiological
Participants assigned to receive the VSV HIV gag vaccine will receive a total dose of 1x10^8 plaque-forming units (PFUs) administered as 5x10^7 PFU in 1 mL by IM injection in both the left and right deltoids at Month 6.
PlaceboBiological
Placebo will consist of sodium chloride for injection, USP 0.9%.
Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceDevice
The HIV-MAG vaccine, IL-12 pDNA adjuvant, and placebos for IL-12 pDNA adjuvant/HIV-MAG vaccines will be delivered IM into the deltoid by the Ichor Medical Systems TDS EP device.

Study groups in NCT01578889
Study group	Role	What they receive
Group 1: Vaccine	Experimental	At study entry and Months 1 and 3, participants will receive HIV-MAG vaccine administered as 0.5 mL by intramuscular (IM) injection in both the left and right deltoids using the Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids. Receives: Biological: HIV-MAG vaccine; Biological: VSV HIV gag vaccine; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 1: Placebo	Placebo comparator	At study entry and Months 1 and 3, participants will receive placebo administered as 0.5 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids. Receives: Biological: Placebo; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 2: Vaccine	Experimental	At study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 250 mcg IL-12 pDNA adjuvant, and divided into two 0.55 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids. Receives: Biological: HIV-MAG vaccine; Biological: IL-12 pDNA adjuvant; Biological: VSV HIV gag vaccine; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 2: Placebo	Placebo comparator	At study entry and Months 1 and 3, participants will receive placebo administered as 0.55 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids. Receives: Biological: Placebo; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 3: Vaccine	Experimental	At study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 1,000 mcg of the IL-12 pDNA adjuvant and divided into two 0.75 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids. Receives: Biological: HIV-MAG vaccine; Biological: IL-12 pDNA adjuvant; Biological: VSV HIV gag vaccine; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 3: Placebo	Placebo comparator	At study entry and Months 1 and 3, participants will receive placebo administered as 0.75 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids. Receives: Biological: Placebo; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 4: Vaccine	Experimental	At study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 1500 mcg of the IL-12 pDNA adjuvant divided into two 0.9 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids. Receives: Biological: HIV-MAG vaccine; Biological: IL-12 pDNA adjuvant; Biological: VSV HIV gag vaccine; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Group 4: Placebo	Placebo comparator	At study entry and Months 1 and 3, participants will receive placebo administered as 0.9 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids. Receives: Biological: Placebo; Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency and severity of local injection/EP site reactogenicity signs and symptoms
Pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness
Measured: Measured through Month 12
Frequency and severity of systemic reactogenicity signs and symptoms
Fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms
Measured: Measured through Month 12
Magnitude of local injection/EP site pain as measured by a visual analog scale
Measured: Measured through Month 12
Frequency of adverse events (AEs) categorized by MedDRA body system, MedDRA preferred term, severity, and assessed relationship to study products
Detailed description of all AEs meeting DAIDS criteria for expedited reporting
Measured: Measured through Month 12
Distribution of values of safety laboratory measures
White blood cells, neutrophils, lymphocytes, hemoglobin, alkaline phosphatase, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, and creatine phosphokinase (CPK) at baseline and at follow-up visits postvaccination
Measured: Measured through Month 12
Number of participants with early discontinuation of vaccinations and reason for discontinuation
Measured: Measured through Month 12
Distribution of responses to questions regarding acceptability of study injections procedures
Measured: Measured through Month 12

Secondary outcomes (4)

Response rate of CD4 T-cell responses measured by intracellular cytokine staining (ICS) for IFN-γ and/or IL-2, to HIV potential T-cell epitope (PTE) peptide pools representing Gag, Pol, Env, Nef, Tat, and Vif
Measured: Measured through Month 12
Response rate of CD8 T-cell responses measured by ICS for IFN-γ and/or IL-2, to HIV PTE peptide pools representing Gag, Pol, Env, Nef, Tat, and Vif
Measured: Measured through Month 12
Response rate of T-cell responses as measured by IFN-γ enzyme-linked immunospot (ELISpot)
Measured: Measured through Month 12
Induction of binding antibodies to HIV-1 gag p55 and HIV-1 6101 env gp160
Measured: Measured through Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Oct 2016

First posted17 Apr 2012 (estimated)
Study startMay 2012
Primary completionSep 2014
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01578889
Sponsor's protocol ID: HVTN 087
Other IDs: 11673
Status last verified: Oct 2021
First submitted: 13 Apr 2012
Last updated: 15 Oct 2021
Results posted: No
Data monitoring committee: Yes

Publications

Egan MA, Megati S, Roopchand V, Garcia-Hand D, Luckay A, Chong SY, Rosati M, Sackitey S, Weiner DB, Felber BK, Pavlakis GN, Israel ZR, Eldridge JH, Sidhu MK. Rational design of a plasmid DNA vaccine capable of eliciting cell-mediated immune responses to multiple HIV antigens in mice. Vaccine. 2006 May 22;24(21):4510-23. doi: 10.1016/j.vaccine.2005.08.024. Epub 2005 Aug 19.
PubMed 16140439
Dolter KE, Evans CF, Ellefsen B, Song J, Boente-Carrera M, Vittorino R, Rosenberg TJ, Hannaman D, Vasan S. Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation. Vaccine. 2011 Jan 17;29(4):795-803. doi: 10.1016/j.vaccine.2010.11.011. Epub 2010 Nov 19.
PubMed 21094270
Hirao LA, Wu L, Khan AS, Hokey DA, Yan J, Dai A, Betts MR, Draghia-Akli R, Weiner DB. Combined effects of IL-12 and electroporation enhances the potency of DNA vaccination in macaques. Vaccine. 2008 Jun 13;26(25):3112-20. doi: 10.1016/j.vaccine.2008.02.036. Epub 2008 Mar 11.
PubMed 18430495
Johnson JE, Coleman JW, Kalyan NK, Calderon P, Wright KJ, Obregon J, Ogin-Wilson E, Natuk RJ, Clarke DK, Udem SA, Cooper D, Hendry RM. In vivo biodistribution of a highly attenuated recombinant vesicular stomatitis virus expressing HIV-1 Gag following intramuscular, intranasal, or intravenous inoculation. Vaccine. 2009 May 14;27(22):2930-9. doi: 10.1016/j.vaccine.2009.03.006. Epub 2009 Mar 13.
PubMed 19428903
Elizaga ML, Li SS, Kochar NK, Wilson GJ, Allen MA, Tieu HVN, Frank I, Sobieszczyk ME, Cohen KW, Sanchez B, Latham TE, Clarke DK, Egan MA, Eldridge JH, Hannaman D, Xu R, Ota-Setlik A, McElrath MJ, Hay CM; NIAID HIV Vaccine Trials Network (HVTN) 087 Study Team. Safety and tolerability of HIV-1 multiantigen pDNA vaccine given with IL-12 plasmid DNA via electroporation, boosted with a recombinant vesicular stomatitis virus HIV Gag vaccine in healthy volunteers in a randomized, controlled clinical trial. PLoS One. 2018 Sep 20;13(9):e0202753. doi: 10.1371/journal.pone.0202753. eCollection 2018.
PubMed 30235286
Li SS, Kochar NK, Elizaga M, Hay CM, Wilson GJ, Cohen KW, De Rosa SC, Xu R, Ota-Setlik A, Morris D, Finak G, Allen M, Tieu HV, Frank I, Sobieszczyk ME, Hannaman D, Gottardo R, Gilbert PB, Tomaras GD, Corey L, Clarke DK, Egan MA, Eldridge JH, McElrath MJ, Frahm N; NIAID HIV Vaccine Trials Network. DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8+ T-Cell Responses by Interleukin-12 Plasmid DNA. Clin Vaccine Immunol. 2017 Nov 6;24(11):e00263-17. doi: 10.1128/CVI.00263-17. Print 2017 Nov.
PubMed 28931520

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an IL-12 pDNA Enhanced HIV-1 Multiantigen pDNA Vaccine Delivered Intramuscularly With Electroporation, With an HIV-1 rVSV Vaccine Boost, in Healthy HIV-Uninfected Adult Participants
ClinicalTrials.gov ID: NCT01578889
Acronym / sponsor ID: HVTN 087
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: May 2012
Primary completion: Sep 2014 (actual)
Study completion: Oct 2016 (actual)
First posted: 17 Apr 2012 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Group 1: Vaccine	Experimental	Biological: HIV-MAG vaccine, Biological: VSV HIV gag vaccine, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine administered as 0.5 mL by intramuscular (IM) injection in both the left and right deltoids using the Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Group 1: Placebo	Placebo comparator	Biological: Placebo, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive placebo administered as 0.5 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids.
Group 2: Vaccine	Experimental	Biological: HIV-MAG vaccine, Biological: IL-12 pDNA adjuvant, Biological: VSV HIV gag vaccine, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 250 mcg IL-12 pDNA adjuvant, and divided into two 0.55 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Group 2: Placebo	Placebo comparator	Biological: Placebo, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive placebo administered as 0.55 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids.
Group 3: Vaccine	Experimental	Biological: HIV-MAG vaccine, Biological: IL-12 pDNA adjuvant, Biological: VSV HIV gag vaccine, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 1,000 mcg of the IL-12 pDNA adjuvant and divided into two 0.75 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Group 3: Placebo	Placebo comparator	Biological: Placebo, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive placebo administered as 0.75 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids.
Group 4: Vaccine	Experimental	Biological: HIV-MAG vaccine, Biological: IL-12 pDNA adjuvant, Biological: VSV HIV gag vaccine, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive HIV-MAG vaccine admixed with 1500 mcg of the IL-12 pDNA adjuvant divided into two 0.9 mL IM injections administered in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive the VSV HIV gag vaccine by IM injection in both the left and right deltoids.
Group 4: Placebo	Placebo comparator	Biological: Placebo, Device: Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceAt study entry and Months 1 and 3, participants will receive placebo administered as 0.9 mL by IM injection in both the left and right deltoids using the Ichor Medical Systems TDS EP device. At Month 6, they will receive placebo by IM injection in both the left and right deltoids.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (25 listed)

Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willing to be followed for the planned duration of the study
Able and willing to provide informed consent
Assessment of understanding: participant demonstrates understanding of this study and completes a questionnaire prior to the first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Willing to receive HIV test results
Willing to discuss HIV infection risks, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit

Key exclusion criteria (37 listed)

Allergy to amide-type local anesthetics (bupivacaine [Marcaine], lidocaine [Xylocaine], mepivacaine [Polocaine/Carbocaine], etidocaine [Duranest], prilocaine [Citanest, EMLA® cream])
Presence of implanted electronic medical device (e.g., pacemaker, implantable cardioverter defibrillator)
Presence of surgical or traumatic metal implant in the upper limb and/or upper torso
Sinus bradycardia (defined as less than 50 bpm on exam) or a history of cardiac arrhythmia: e.g., supraventricular tachycardia, atrial fibrillation, or frequent ectopy
Neurological or neuropsychiatric disorder that may interfere with the assessment of safety: e.g., frequent recurring headaches (i.e., a pattern of more than one headache per month affecting activities of daily living [ADLs]/work, frequent or severe/complicated migraines, cluster headaches), a chronic pain syndrome, dizziness, history of meningitis or encephalitis, cranial/spinal/peripheral neuropathy, limb weakness or paralysis, movement disorder, narcolepsy, stroke with sequelae, moderate/severe major depressive disorder, moderate/severe bipolar disorder

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
HIV-MAG vaccineParticipants assigned to receive the HIV-MAG vaccine will receive 3 mg of the vaccine with bupivacaine, alone or admixed with one of three doses of the IL-12 pDNA adjuvant.	Biological	Group 1: Vaccine, Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine
IL-12 pDNA adjuvantParticipants assigned to receive the IL-12 plasmid (IL-12 pDNA) adjuvant will receive one of three doses (total of 250 mcg, 1000 mcg, or 1500 mcg) of the adjuvant admixed with the HIV-MAG vaccine.	Biological	Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine
VSV HIV gag vaccineParticipants assigned to receive the VSV HIV gag vaccine will receive a total dose of 1x10^8 plaque-forming units (PFUs) administered as 5x10^7 PFU in 1 mL by IM injection in both the left and right deltoids at Month 6.	Biological	Group 1: Vaccine, Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine
PlaceboPlacebo will consist of sodium chloride for injection, USP 0.9%.	Biological	Group 1: Placebo, Group 2: Placebo, Group 3: Placebo, Group 4: Placebo
Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) deviceThe HIV-MAG vaccine, IL-12 pDNA adjuvant, and placebos for IL-12 pDNA adjuvant/HIV-MAG vaccines will be delivered IM into the deltoid by the Ichor Medical Systems TDS EP device.	Device	Group 1: Placebo, Group 1: Vaccine, Group 2: Placebo, Group 2: Vaccine, Group 3: Placebo, Group 3: Vaccine, Group 4: Placebo, Group 4: Vaccine

Primary outcome

Frequency and severity of local injection/EP site reactogenicity signs and symptoms
Time frame: Measured through Month 12
Pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness
Frequency and severity of systemic reactogenicity signs and symptoms
Time frame: Measured through Month 12
Fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and maximum severity of systemic symptoms
Magnitude of local injection/EP site pain as measured by a visual analog scale
Time frame: Measured through Month 12
Frequency of adverse events (AEs) categorized by MedDRA body system, MedDRA preferred term, severity, and assessed relationship to study products
Time frame: Measured through Month 12
Detailed description of all AEs meeting DAIDS criteria for expedited reporting
Distribution of values of safety laboratory measures
Time frame: Measured through Month 12
White blood cells, neutrophils, lymphocytes, hemoglobin, alkaline phosphatase, platelets, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, and creatine phosphokinase (CPK) at baseline and at follow-up visits postvaccination
Number of participants with early discontinuation of vaccinations and reason for discontinuation
Time frame: Measured through Month 12
Distribution of responses to questions regarding acceptability of study injections procedures
Time frame: Measured through Month 12

4 secondary outcomes

Response rate of CD4 T-cell responses measured by intracellular cytokine staining (ICS) for IFN-γ and/or IL-2, to HIV potential T-cell epitope (PTE) peptide pools representing Gag, Pol, Env, Nef, Tat, and Vif
Time frame: Measured through Month 12
Response rate of CD8 T-cell responses measured by ICS for IFN-γ and/or IL-2, to HIV PTE peptide pools representing Gag, Pol, Env, Nef, Tat, and Vif
Time frame: Measured through Month 12
Response rate of T-cell responses as measured by IFN-γ enzyme-linked immunospot (ELISpot)
Time frame: Measured through Month 12
Induction of binding antibodies to HIV-1 gag p55 and HIV-1 6101 env gp160
Time frame: Measured through Month 12

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 15 Oct 2021.
Background: PubMed 16140439Egan MA, Megati S, Roopchand V, Garcia-Hand D, Luckay A, Chong SY, Rosati M, Sackitey S, Weiner DB, Felber BK, Pavlakis GN, Israel ZR, Eldridge JH, Sidhu MK. Rational design of a plasmid DNA vaccine capable of eliciting cell-mediated immune responses to multiple HIV antigens in mice. Vaccine. 2006 May 22;24(21):4510-23. doi: 10.1016/j.vaccine.2005.08.024. Epub 2005 Aug 19.
Background: PubMed 21094270Dolter KE, Evans CF, Ellefsen B, Song J, Boente-Carrera M, Vittorino R, Rosenberg TJ, Hannaman D, Vasan S. Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation. Vaccine. 2011 Jan 17;29(4):795-803. doi: 10.1016/j.vaccine.2010.11.011. Epub 2010 Nov 19.
Background: PubMed 18430495Hirao LA, Wu L, Khan AS, Hokey DA, Yan J, Dai A, Betts MR, Draghia-Akli R, Weiner DB. Combined effects of IL-12 and electroporation enhances the potency of DNA vaccination in macaques. Vaccine. 2008 Jun 13;26(25):3112-20. doi: 10.1016/j.vaccine.2008.02.036. Epub 2008 Mar 11.
Background: PubMed 19428903Johnson JE, Coleman JW, Kalyan NK, Calderon P, Wright KJ, Obregon J, Ogin-Wilson E, Natuk RJ, Clarke DK, Udem SA, Cooper D, Hendry RM. In vivo biodistribution of a highly attenuated recombinant vesicular stomatitis virus expressing HIV-1 Gag following intramuscular, intranasal, or intravenous inoculation. Vaccine. 2009 May 14;27(22):2930-9. doi: 10.1016/j.vaccine.2009.03.006. Epub 2009 Mar 13.
Derived from this study: PubMed 30235286Elizaga ML, Li SS, Kochar NK, Wilson GJ, Allen MA, Tieu HVN, Frank I, Sobieszczyk ME, Cohen KW, Sanchez B, Latham TE, Clarke DK, Egan MA, Eldridge JH, Hannaman D, Xu R, Ota-Setlik A, McElrath MJ, Hay CM; NIAID HIV Vaccine Trials Network (HVTN) 087 Study Team. Safety and tolerability of HIV-1 multiantigen pDNA vaccine given with IL-12 plasmid DNA via electroporation, boosted with a recombinant vesicular stomatitis virus HIV Gag vaccine in healthy volunteers in a randomized, controlled clinical trial. PLoS One. 2018 Sep 20;13(9):e0202753. doi: 10.1371/journal.pone.0202753. eCollection 2018.
Derived from this study: PubMed 28931520Li SS, Kochar NK, Elizaga M, Hay CM, Wilson GJ, Cohen KW, De Rosa SC, Xu R, Ota-Setlik A, Morris D, Finak G, Allen M, Tieu HV, Frank I, Sobieszczyk ME, Hannaman D, Gottardo R, Gilbert PB, Tomaras GD, Corey L, Clarke DK, Egan MA, Eldridge JH, McElrath MJ, Frahm N; NIAID HIV Vaccine Trials Network. DNA Priming Increases Frequency of T-Cell Responses to a Vesicular Stomatitis Virus HIV Vaccine with Specific Enhancement of CD8+ T-Cell Responses by Interleukin-12 Plasmid DNA. Clin Vaccine Immunol. 2017 Nov 6;24(11):e00263-17. doi: 10.1128/CVI.00263-17. Print 2017 Nov.

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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.

Christine (Mhorag) Hay study chair

University of Rochester

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 25 inclusion and 37 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 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. 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 and severity of local injection/EP site reactogenicity signs and symptoms (time frame: Measured through Month 12). The study lists 7 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 NCT01578889, which also lists 6 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 15 Oct 2021.