HIV InfectionsPhase 1NCT01266616

Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults

A Phase 1 study testing Profectus HIV MAG pDNA vaccine and IL-12 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: HIV Infections
What is being tested?: Profectus HIV MAG pDNA vaccine and IL-12
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 13 sitesUnited States
Study dates: Mar 2011to Apr 2013
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

HIV-1 infected
Stable antiretroviral therapy (ART) for a minimum of 6 consecutive months prior to study entry and intention to remain on stable ART until study completion
CD4 T-cell count greater than or equal to 500 cells/mm3 (within 30 days prior to study entry)
At least two measurements of HIV-1 RNA levels less than or equal to 200 copies/mL (first measurement must be performed at least 6 months prior to study entry and second measurement must be performed between 6 months prior to study entry and at least 30 days prior to study entry)
Screening HIV-1 RNA less than 50 copies/mL (within 30 days prior to study entry)
Hepatitis B surface antigen negative (within 30 days prior to study entry)

Show all 17Show fewer

Hepatitis C antibody negative or, if hepatitis C antibody positive, hepatitis C virus RNA negative (within 30 days prior to study entry)
Certain laboratory values obtained within 30 days prior to study entry; more information can be found in the protocol
Females of reproductive potential must have a negative urine pregnancy test within 3 days prior to study entry
All study participants participating in sexual activity that could lead to pregnancy must agree to use at least one of the following forms of birth control for at least 21 days prior to study entry until the final study visit:
Condoms (male or female) with or without a spermicidal agent
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormone-based contraceptive
Females who are not of reproductive potential are eligible without requiring the use of a contraceptive
Ability and willingness of subject to provide written informed consent
Collection of a pre-entry PBMC specimen for immunologic assays and entered into the Laboratory Data Management System (LDMS)

Who cannot join

Confirmed (defined as two consecutive values) CD4 T-cell count less than 200 cells/mm3 at any time or any history or subject recollection of CD4 T-cell count less than 200 cells/mm3 prior to screening
Any active malignancy that may require chemotherapy or radiation therapy
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate IM injection
A skin-fold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (on the medial deltoid muscles) that exceeds 40 mm
Use of immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, granulocyte macrophage colony-stimulating factor (GM-CSF), chondrocyte colony-stimulating factor (C-CSF), IFN, or interleukin-2 (IL-2) (within 30 days prior to study entry)
Pregnancy or breastfeeding

Show all 20Show fewer

Use of any prior HIV vaccine (prophylactic and/or therapeutic) within 1 year before study entry
Use of any investigational treatment within 6 months before study entry
Use of any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) within 4 weeks prior to study entry
Use of any infusion blood product or immune globulin within 3 months prior to study entry
Known or suspected hypersensitivity to any vaccine component, including hypersensitivity to amide-type local anesthetics, such as lidocaine (Xylocaine), mepivacaine (Polocaine/Carbocaine), etidocaine (Duranest), bupivacaine (Marcaine), or prilocaine
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization within 7 days prior to study entry
Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillators, nerve stimulators, or deep brain stimulators
History of cardiac arrhythmia or palpitations (e.g., supraventricular tachycardia, atrial fibrillation, frequent ectopy, or sinus bradycardia [i.e., <50 beats per minute on exam]) prior to study entry (NOTE: Sinus arrhythmia is not excluded)
History of syncope or fainting episode within 1 year of study entry
Seizure disorder or any history of prior seizure
Extensive tattoos covering the site of administration (upper left and right medial deltoid muscles)
Presence of any surgical or traumatic metal implants at the site of administration (medial deltoid muscles)
Any chronic inflammatory disease (e.g., ankylosing spondylitis, psoriasis, inflammatory bowel disease)

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

University of Colorado Hospital CRS
Aurora, Colorado, 80045
Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS
Boston, Massachusetts, 02114
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, 02115
Cincinnati CRS
Cincinnati, Ohio, 45219
Houston AIDS Research Team CRS
Houston, Texas, 77030
UCLA CARE Center CRS
Los Angeles, California, 90035
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, 94304-5350
Penn Therapeutics Crs
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213-2582
Trillium Health ACTG CRS
Rochester, New York, 14607
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
Ucsf Hiv/Aids Crs
San Francisco, California, 94110
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I Randomized, Partially Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen (HIV MAG) pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation (IM/EP) or Intramuscularly in HIV-1 Infected Adults Receiving ART

Read the detailed description

Although highly active antiretroviral therapy (HAART) has greatly reduced HIV infection-related morbidity and mortality, individual response to therapy can be variable. Therapeutic vaccination works by augmenting virus-specific immunity and can be given with or without immunomodulatory agents or adjuvants. In conjunction with HAART, therapeutic vaccination may be a more effective treatment for the suppression of HIV-1 replication. This study will examine the safety and efficacy of giving an investigational vaccine with or without IL-12 in HIV-1 infected adults receiving HAART. This study will also test whether delivering the vaccine using EP is safe and increases the efficacy of the vaccine.

Participation in this study will last approximately 36 weeks. Participants will be randomly assigned to one of five cohorts. Cohort 1 will receive the HIV multi-antigen plasmid DNA (HIV MAG pDNA) vaccine or placebo intramuscularly (IM) in the upper arm followed by EP. Cohorts 2 through 4 will receive the HIV MAG pDNA vaccine and sequentially increasing doses of GENEVAX IL-12 pDNA or placebo by IM/EP. Cohort 5 will receive the HIV MAG pDNA vaccine with the highest dose of IL-12 pDNA or placebo by needle and syringe in the upper arm.

Participants receive two injections at Weeks 0, 4, and 12. Participants will complete a questionnaire that assesses the acceptability of the vaccine and remain at the clinic 30 minutes for observation after each vaccination. Participants will be contacted by telephone 2 to 3 days post-vaccination to assess vaccination-related signs and/or symptoms. All participants will be asked to record their temperatures and any symptoms they experience daily for 4 days following each vaccination on a Vaccination Report Card (VRC). All nonstudy vaccines or medications should also be recorded on the VRC. Study visits will occur at Weeks 0, 1, 2, 4, 5, 6, 8, 12, 13, 14, 16, 24, and 36. At most visits, participants will undergo a physical examination. Women of reproductive potential will also undergo pregnancy testing before receiving injections on Weeks 0, 4, and 12. Blood will be drawn at various time points to evaluate participants' health and measure immunologic markers, CD4 and CD8 T-cell counts, and cytokine levels. Blood and plasma will also be stored for future exploratory studies.

Conditions: HIV Infections
Being tested: Profectus HIV MAG pDNA vaccine, IL-12, Placebo
Keywords: Interleukin-12, 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.

Profectus HIV MAG pDNA vaccineBiological
3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and 12
IL-12Biological
Administered at Weeks 0, 4, and 12
PlaceboOther
Saline injections at Weeks 0, 4, and 12

Study groups in NCT01266616
Study group	Role	What they receive
Cohort 1: Vaccine alone IM/EP	Experimental	HIV MAG pDNA alone IM/EP Receives: Biological: Profectus HIV MAG pDNA vaccine
Cohort 1: Placebo	Placebo comparator	Placebo given as an injection in each upper arm Receives: Other: Placebo
Cohort 2: Vaccine plus IL-12 IM/EP	Experimental	HIV MAG pDNA plus 50 mcg of IL-12 pDNA IM/EP Receives: Biological: Profectus HIV MAG pDNA vaccine; Biological: IL-12
Cohort 2: Placebo	Placebo comparator	Placebo given as an injection in each upper arm Receives: Other: Placebo
Cohort 3: Vaccine plus IL-12 IM/EP	Experimental	HIV MAG pDNA plus 250 mcg of IL-12 pDNA IM/EP Receives: Biological: Profectus HIV MAG pDNA vaccine; Biological: IL-12
Cohort 3: Placebo	Placebo comparator	Placebo given as an injection in each upper arm Receives: Other: Placebo
Cohort 4: Vaccine plus IL-12 IM/EP	Experimental	HIV MAG pDNA plus 1,000 mcg of IL-12 pDNA IM/EP Receives: Biological: Profectus HIV MAG pDNA vaccine; Biological: IL-12
Cohort 4: Placebo	Placebo comparator	Placebo given as an injection in each upper arm Receives: Other: Placebo
Cohort 5: Vaccine plus IL-12 IM	Experimental	HIV MAG pDNA plus 1,000 mcg (or highest dose reached) IL-12 pDNA IM Receives: Biological: Profectus HIV MAG pDNA vaccine; Biological: IL-12
Cohort 5: Placebo	Placebo comparator	Placebo given as an injection in each upper arm Receives: Other: Placebo

What is being measured

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

Occurrence of at least one greater than Grade 3 adverse event (AE) including signs/symptoms, lab toxicities, and/or clinical events that is possibly, probably, or definitely related to study treatment, as judged by the core team
Measured: From the first day of study treatment until 28 days after the last study vaccine administration
Change in the number of interferon (IFN)-gamma generating (in response to gag) CD4 T cells/million peripheral blood mononuclear cells (PBMCs) as measured by intracellular cytokine staining (ICS)
Measured: From Baseline to Week 14

Secondary outcomes (5)

Answering "no" to the question, "In your opinion, would this study's vaccination procedure be acceptable as part of a treatment for HIV, if it proved to be effective?"
Measured: From Week 0 to Week 36
Answering "no" to the question, "In your opinion, would this study's vaccination procedure be acceptable if it could contribute to increased scientific knowledge about how best to administer vaccines to prevent or treat infections?"
Measured: From Week 0 to Week 36
Premature treatment discontinuation for reasons related to study treatment or related to any real or perceived effect of study vaccination or its administration
Measured: From Week 0 to Week 36
Rated pain (for participants administered vaccine/placebo by the EP device)
Measured: When the device was placed on the skin and the vaccine/placebo was injected; at the time of the electrical stimulation and muscle contraction; and at 10 and 30 minutes after the procedure was completed at Weeks 0, 4, and 12
Changes from baseline and absolute values of multiple functions of CD4 and CD8 T cells in response to gag and other vaccine-coded antigens individually and in sum
Measured: At Week 8, Week 14, and possibly other time points depending on the first set of data in an ICS assay

Timeline

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

Mar 2011Apr 2013

First posted24 Dec 2010 (estimated)
Study startMar 2011
Primary completionOct 2012
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01266616
Sponsor's protocol ID: A5281
Other IDs: 10846
Status last verified: Oct 2021
First submitted: 23 Dec 2010
Last updated: 1 Nov 2021
Results posted: No
Data monitoring committee: Yes

Publications

Finzi D, Blankson J, Siliciano JD, Margolick JB, Chadwick K, Pierson T, Smith K, Lisziewicz J, Lori F, Flexner C, Quinn TC, Chaisson RE, Rosenberg E, Walker B, Gange S, Gallant J, Siliciano RF. Latent infection of CD4+ T cells provides a mechanism for lifelong persistence of HIV-1, even in patients on effective combination therapy. Nat Med. 1999 May;5(5):512-7. doi: 10.1038/8394.
PubMed 10229227
Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
PubMed 8207839
Luxembourg A, Evans CF, Hannaman D. Electroporation-based DNA immunisation: translation to the clinic. Expert Opin Biol Ther. 2007 Nov;7(11):1647-64. doi: 10.1517/14712598.7.11.1647.
PubMed 17961089
Jacobson JM, Zheng L, Wilson CC, Tebas P, Matining RM, Egan MA, Eldridge J, Landay AL, Clifford DB, Luetkemeyer AF, Tiu J, Martinez AL, Janik J, Spitz TA, Hural J, McElrath J, Frahm N; ACTG A5281 Protocol Team. The Safety and Immunogenicity of an Interleukin-12-Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection. J Acquir Immune Defic Syndr. 2016 Feb 1;71(2):163-71. doi: 10.1097/QAI.0000000000000830.
PubMed 26761518

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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Randomized, Partially Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a Cytokine Enhanced HIV-1 Multi-Antigen (HIV MAG) pDNA Vaccine Delivered Intramuscularly Followed by in Vivo Electroporation (IM/EP) or Intramuscularly in HIV-1 Infected Adults Receiving ART
ClinicalTrials.gov ID: NCT01266616
Acronym / sponsor ID: A5281
Conditions: HIV Infections
Keywords: Interleukin-12, Electroporation, HIV Therapeutic Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Mar 2011
Primary completion: Oct 2012 (actual)
Study completion: Apr 2013 (actual)
First posted: 24 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Cohort 1: Vaccine alone IM/EP	Experimental	Biological: Profectus HIV MAG pDNA vaccineHIV MAG pDNA alone IM/EP
Cohort 1: Placebo	Placebo comparator	Other: PlaceboPlacebo given as an injection in each upper arm
Cohort 2: Vaccine plus IL-12 IM/EP	Experimental	Biological: Profectus HIV MAG pDNA vaccine, Biological: IL-12HIV MAG pDNA plus 50 mcg of IL-12 pDNA IM/EP
Cohort 2: Placebo	Placebo comparator	Other: PlaceboPlacebo given as an injection in each upper arm
Cohort 3: Vaccine plus IL-12 IM/EP	Experimental	Biological: Profectus HIV MAG pDNA vaccine, Biological: IL-12HIV MAG pDNA plus 250 mcg of IL-12 pDNA IM/EP
Cohort 3: Placebo	Placebo comparator	Other: PlaceboPlacebo given as an injection in each upper arm
Cohort 4: Vaccine plus IL-12 IM/EP	Experimental	Biological: Profectus HIV MAG pDNA vaccine, Biological: IL-12HIV MAG pDNA plus 1,000 mcg of IL-12 pDNA IM/EP
Cohort 4: Placebo	Placebo comparator	Other: PlaceboPlacebo given as an injection in each upper arm
Cohort 5: Vaccine plus IL-12 IM	Experimental	Biological: Profectus HIV MAG pDNA vaccine, Biological: IL-12HIV MAG pDNA plus 1,000 mcg (or highest dose reached) IL-12 pDNA IM
Cohort 5: Placebo	Placebo comparator	Other: PlaceboPlacebo given as an injection in each upper arm

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (17 listed)

HIV-1 infected
Stable antiretroviral therapy (ART) for a minimum of 6 consecutive months prior to study entry and intention to remain on stable ART until study completion
CD4 T-cell count greater than or equal to 500 cells/mm3 (within 30 days prior to study entry)
At least two measurements of HIV-1 RNA levels less than or equal to 200 copies/mL (first measurement must be performed at least 6 months prior to study entry and second measurement must be performed between 6 months prior to study entry and at least 30 days prior to study entry)
Screening HIV-1 RNA less than 50 copies/mL (within 30 days prior to study entry)

Key exclusion criteria (20 listed)

Confirmed (defined as two consecutive values) CD4 T-cell count less than 200 cells/mm3 at any time or any history or subject recollection of CD4 T-cell count less than 200 cells/mm3 prior to screening
Any active malignancy that may require chemotherapy or radiation therapy
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate IM injection
A skin-fold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (on the medial deltoid muscles) that exceeds 40 mm
Use of immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, granulocyte macrophage colony-stimulating factor (GM-CSF), chondrocyte colony-stimulating factor (C-CSF), IFN, or interleukin-2 (IL-2) (within 30 days prior to study entry)

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
Profectus HIV MAG pDNA vaccine3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and 12	Biological	Cohort 1: Vaccine alone IM/EP, Cohort 2: Vaccine plus IL-12 IM/EP, Cohort 3: Vaccine plus IL-12 IM/EP, Cohort 4: Vaccine plus IL-12 IM/EP, Cohort 5: Vaccine plus IL-12 IM
IL-12Administered at Weeks 0, 4, and 12	Biological	Cohort 2: Vaccine plus IL-12 IM/EP, Cohort 3: Vaccine plus IL-12 IM/EP, Cohort 4: Vaccine plus IL-12 IM/EP, Cohort 5: Vaccine plus IL-12 IM
PlaceboSaline injections at Weeks 0, 4, and 12	Other	Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo, Cohort 5: Placebo

Primary outcome

Occurrence of at least one greater than Grade 3 adverse event (AE) including signs/symptoms, lab toxicities, and/or clinical events that is possibly, probably, or definitely related to study treatment, as judged by the core team
Time frame: From the first day of study treatment until 28 days after the last study vaccine administration
Change in the number of interferon (IFN)-gamma generating (in response to gag) CD4 T cells/million peripheral blood mononuclear cells (PBMCs) as measured by intracellular cytokine staining (ICS)
Time frame: From Baseline to Week 14

5 secondary outcomes

Answering "no" to the question, "In your opinion, would this study's vaccination procedure be acceptable as part of a treatment for HIV, if it proved to be effective?"
Time frame: From Week 0 to Week 36
Answering "no" to the question, "In your opinion, would this study's vaccination procedure be acceptable if it could contribute to increased scientific knowledge about how best to administer vaccines to prevent or treat infections?"
Time frame: From Week 0 to Week 36
Premature treatment discontinuation for reasons related to study treatment or related to any real or perceived effect of study vaccination or its administration
Time frame: From Week 0 to Week 36
Rated pain (for participants administered vaccine/placebo by the EP device)
Time frame: When the device was placed on the skin and the vaccine/placebo was injected; at the time of the electrical stimulation and muscle contraction; and at 10 and 30 minutes after the procedure was completed at Weeks 0, 4, and 12
Changes from baseline and absolute values of multiple functions of CD4 and CD8 T cells in response to gag and other vaccine-coded antigens individually and in sum
Time frame: At Week 8, Week 14, and possibly other time points depending on the first set of data in an ICS assay

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 1 Nov 2021.
Background: PubMed 10229227Finzi D, Blankson J, Siliciano JD, Margolick JB, Chadwick K, Pierson T, Smith K, Lisziewicz J, Lori F, Flexner C, Quinn TC, Chaisson RE, Rosenberg E, Walker B, Gange S, Gallant J, Siliciano RF. Latent infection of CD4+ T cells provides a mechanism for lifelong persistence of HIV-1, even in patients on effective combination therapy. Nat Med. 1999 May;5(5):512-7. doi: 10.1038/8394.
Background: PubMed 8207839Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
Background: PubMed 17961089Luxembourg A, Evans CF, Hannaman D. Electroporation-based DNA immunisation: translation to the clinic. Expert Opin Biol Ther. 2007 Nov;7(11):1647-64. doi: 10.1517/14712598.7.11.1647.
Derived from this study: PubMed 26761518Jacobson JM, Zheng L, Wilson CC, Tebas P, Matining RM, Egan MA, Eldridge J, Landay AL, Clifford DB, Luetkemeyer AF, Tiu J, Martinez AL, Janik J, Spitz TA, Hural J, McElrath J, Frahm N; ACTG A5281 Protocol Team. The Safety and Immunogenicity of an Interleukin-12-Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection. J Acquir Immune Defic Syndr. 2016 Feb 1;71(2):163-71. doi: 10.1097/QAI.0000000000000830.

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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.

Jeffrey Jacobson, MD study chair

Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine

13 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 Profectus HIV MAG pDNA vaccine and IL-12 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 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?

The sponsor lists 17 inclusion and 20 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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?

Occurrence of at least one greater than Grade 3 adverse event (AE) including signs/symptoms, lab toxicities, and/or clinical events that is possibly, probably, or definitely related to study treatment, as judged by the core team (time frame: From the first day of study treatment until 28 days after the last study vaccine administration). The study lists 2 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 NCT01266616, which also lists 4 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 1 Nov 2021.