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HIV InfectionsPhase 1NCT02431767

Evaluating the Safety and Immunogenicity of PENNVAX®-GP DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adults

A Phase 1 study testing PENNVAX®-GP HIV-1 DNA vaccine and Interleukin-12 (IL-12) DNA adjuvant in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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

The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
PENNVAX®-GP HIV-1 DNA vaccine and Interleukin-12 (IL-12) DNA adjuvant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
4 sitesUnited States
Study dates
Aug 2015to 20 Dec 2017
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
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • General and Demographic Criteria:
  • Age of 18 to 55 years
  • Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
  • Ability and willingness to provide informed consent
  • Assessment of understanding: participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
  • Agrees not to enroll in another study of an investigational research agent
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  • Good general health as shown by medical history, physical exam, and screening laboratory tests
  • HIV-Related Criteria:
  • Willingness to receive HIV test results
  • Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
  • Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
  • Laboratory Inclusion Values:
  • Hemogram/Complete Blood Count (CBC)
  • 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 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
  • Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal; creatine phosphokinase (CPK) less than or equal to 2.0 times the institutional upper limit of normal.
  • Virology
  • Negative HIV-1 and -2 blood test: participants must have a negative Food and Drug Administration (FDA)-approved enzyme immunoassay
  • Negative hepatitis B surface antigen (HBsAg)
  • Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction if the anti-HCV is positive
  • Urine
  • 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 with red blood cells levels within institutional normal range).
  • Reproductive Status:
  • Participants who were born female: negative serum or urine beta human chorionic gonadotropin pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
  • A participant who was born female must:
  • Agree to consistently use effective contraception (see Appendix B of the protocol) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. More information on this criterion is available in the protocol.
  • 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.
  • 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

  • General:
  • Blood products received within 120 days before first vaccination
  • Investigational research agents received within 30 days before first vaccination
  • Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
  • Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 098 study
  • Pregnant or breastfeeding
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  • Subcutaneous contraceptive device
  • Vaccines and Other Injections:
  • HIV vaccine(s) received in a prior HIV vaccine trial. For participants who have received control/placebo in an HIV vaccine trial, the HVTN 098 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 participants who have received control/placebo in an experimental vaccine trial, the HVTN 098 PSRT will determine eligibility on a case-by-case basis. For participants who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 098 PSRT on a case-by-case basis.
  • 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)
  • 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
  • Immune System:
  • Immunosuppressive medications received within 168 days before first vaccination. (Not excluded: [1] corticosteroid nasal spray; [2] low-dose inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment.
  • Serious adverse reactions to vaccines, including history of 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.)
  • Immunoglobulin received within 60 days before first vaccination
  • Autoimmune disease
  • Immunodeficiency
  • Clinically Significant Medical Conditions:
  • History or presence of keloid scar formation or hypertrophic scar
  • Presence of implanted electronic medical device (e.g., pacemaker, implantable cardioverter defibrillator)
  • Presence of surgical or traumatic metal implant in the upper arm and/or upper torso
  • History of cardiac arrhythmia (e.g., supraventricular tachycardia, atrial fibrillation, or frequent ectopy)
  • Untreated or incompletely treated syphilis infection
  • 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 is available 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. For example:
  • Tattoo overlying the injection site
  • Skin conditions at the injection site
  • Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
  • Current anti-tuberculosis prophylaxis or therapy
  • Asthma exclusion criteria:
  • Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program Expert Panel report).
  • Exclude a participant who:
  • Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
  • Uses moderate/high dose inhaled corticosteroids, or
  • In the past year has either of the following: 1) Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids; 2) Needed emergency care, urgent care, hospitalization, or intubation for asthma.
  • 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
  • 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
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
  • Malignancy (Not excluded: participant who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
  • Seizure disorder: History of seizure(s) within past three years. Also exclude if participant has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
  • Asplenia: any condition resulting in the absence of a functional spleen
  • History of hereditary angioedema, acquired angioedema, or idiopathic angioedema

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • The Hope Clinic of the Emory Vaccine Center CRS

    Decatur, Georgia, 30030

  • Vanderbilt Vaccine (VV) CRS

    Nashville, Tennessee, 37232-2582

  • University of Rochester Vaccines to Prevent HIV Infection CRS

    Rochester, New York, 14642

  • Seattle Vaccine and Prevention CRS

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX®-GP (Gag, Pol, Env) DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adult Participants

The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

Read the detailed description

The purpose of this study is to evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and IL-12 DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults. All study injections will be given using an EP device, which uses an electric pulse to briefly open tiny pores in the cells. Researchers will evaluate whether EP increases the immune response to the vaccine.

The study will enroll participants in four groups. Within each group, participants will be randomly assigned to receive the PENNVAX®-GP DNA vaccine/IL-12 DNA adjuvant or placebo. Each group will receive different doses of the vaccine. Enrollment will begin with Group 1, which will receive a low dose of the vaccine and adjuvant. Study staff will review safety data from Group 1 before enrolling people in Groups 2, 3, and 4 at higher doses. Participants in all groups will receive injections at study entry (Day 0) and Months 1, 3, and 6. At each injection visit, participants in Groups 1 and 4 will receive injections in one arm, and participants in Groups 2 and 3 will receive injections in both arms. Groups 1, 2, and 3 will receive ID injections, and Group 4 will receive IM injections.

Participants will attend study visits at Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9, and 12. Visits will include physical examinations, urine collection, blood collection, HIV and risk reduction counseling, and assessments and questionnaires. Some participants may have photographs taken of the injection site (this is optional). Study staff will contact participants at Month 18 for follow-up health monitoring.

Conditions
HIV Infections
Being tested
PENNVAX®-GP HIV-1 DNA vaccine, Interleukin-12 (IL-12) DNA adjuvant, Placebo
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®-GP HIV-1 DNA vaccineBiological

    Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.

  • Interleukin-12 (IL-12) DNA adjuvantBiological

    Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.

  • PlaceboBiological

    Sterile Water for Injection, USP. Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.

Study groups in NCT02431767
Study groupRoleWhat they receive
Group 1: TreatmentExperimentalParticipants will receive the PENNVAX®-GP vaccine 0.6 mg admixed with IL-12 DNA 0.2 mg to be administered as 0.1 mL by intradermal (ID) injection over either deltoid at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Receives: Biological: PENNVAX®-GP HIV-1 DNA vaccine; Biological: Interleukin-12 (IL-12) DNA adjuvant
Group 1: PlaceboPlacebo comparatorParticipants will receive placebo to be administered as 0.1 mL ID over either deltoid at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Receives: Biological: Placebo
Group 2: TreatmentExperimentalParticipants will receive the PENNVAX®-GP vaccine 0.8 mg to be administered as 0.1 mL ID over their left and right deltoids (unless medically contraindicated) at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Receives: Biological: PENNVAX®-GP HIV-1 DNA vaccine
Group 2: PlaceboPlacebo comparatorParticipants will receive placebo to be administered as 0.1 mL ID over their left and right deltoids (unless medically contraindicated) at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Receives: Biological: Placebo
Group 3: TreatmentExperimentalParticipants will receive the PENNVAX®-GP vaccine 0.8 mg admixed with IL-12 DNA 0.2 mg to be administered as 0.1 mL ID over their left and right deltoids (unless medically contraindicated) at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Receives: Biological: PENNVAX®-GP HIV-1 DNA vaccine; Biological: Interleukin-12 (IL-12) DNA adjuvant
Group 3: PlaceboPlacebo comparatorParticipants will receive placebo to be administered as 0.1 mL ID over their left and right deltoids (unless medically contraindicated) at Months 0, 1, 3, and 6 using the CELLECTRA® 3P EP system.
Receives: Biological: Placebo
Group 4: TreatmentExperimentalParticipants will receive the PENNVAX®-GP vaccine 8 mg admixed with IL-12 DNA 1 mg to be administered as 1 mL intramuscular (IM) injection in either deltoid at Months 0, 1, 3, and 6 using the CELLECTRA® 5P EP system.
Receives: Biological: PENNVAX®-GP HIV-1 DNA vaccine; Biological: Interleukin-12 (IL-12) DNA adjuvant
Group 4: PlaceboPlacebo comparatorParticipants will receive placebo to be administered as 1 mL IM in either deltoid at Months 0, 1, 3, and 6 using the CELLECTRA® 5P EP system.
Receives: Biological: Placebo

What is being measured

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

  1. Frequency of reactogenicity signs and symptoms

    Measured: Measured through Month 18

  2. Severity of reactogenicity signs and symptoms

    Measured: Measured through Month 18

  3. Magnitude of local injection/EP site pain as measured by a visual analog scale (VAS)

    Measured: Measured through Month 18

  4. Frequency of adverse events (AEs)

    Categorized by MedDRA body system, MedDRA preferred term, severity, and assessed relationship to study products.

    Measured: Measured through Month 18

  5. Measurement of white blood cells

    Measured: Measured through Month 12

  6. Measurement of neutrophils

    Measured: Measured through Month 12

  7. Measurement of lymphocytes

    Measured: Measured through Month 12

  8. Measurement of hemoglobin

    Measured: Measured through Month 12

  9. Measurement of alkaline phosphatase

    Measured: Measured through Month 12

  10. Measurement of platelets

    Measured: Measured through Month 12

  11. Measurement of alanine aminotransferase (ALT)

    Measured: Measured through Month 12

  12. Measurement of aspartate aminotransferase (AST)

    Measured: Measured through Month 12

  13. Measurement of creatinine

    Measured: Measured through Month 12

  14. Measurement of creatine phosphokinase (CPK)

    Measured: Measured through Month 12

  15. Number of participants with early discontinuation of vaccinations

    Measured: Measured through Month 12

  16. Distribution of responses to questions regarding acceptability of study injection procedures

    Measured: Measured through Month 12

Secondary outcomes (5)

  1. Response rate of CD4+ T-cell responses measured by flow cytometry, to HIV-1-specific peptide pools representing gag, pol, env following the third and fourth vaccinations

    Measured: Measured through Month 12

  2. Response rate of CD8+ T-cell responses measured by flow cytometry, to HIV-1-specific peptide pools representing gag, pol, env following the third and fourth vaccinations

    Measured: Measured through Month 12

  3. Frequency and magnitude of HIV-1 specific binding antibody (Ab) responses as assessed by multiplex assay following the third and fourth vaccinations

    Measured: Measured through Month 12

  4. Neutralizing antibody magnitude and breadth against tier 1 and, if applicable, tier 2 HIV-1 isolates as assessed by area under the magnitude-breadth curves following the third and fourth vaccinations

    Measured: Measured through Month 12

  5. B-cell response rate and magnitude measured by B-cell enzyme-linked immunospot (ELISpot) to quantify Env-specific antibody producing B cells following the third and fourth vaccinations

    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.

  1. First posted1 May 2015 (estimated)
  2. Study startAug 2015
  3. Primary completion8 Jun 2017
  4. Study completion20 Dec 2017

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02431767
Sponsor's protocol ID
HVTN 098
Other IDs
11890
Status last verified
Oct 2021
First submitted
28 Apr 2015
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • De Rosa SC, Edupuganti S, Huang Y, Han X, Elizaga M, Swann E, Polakowski L, Kalams SA, Keefer MC, Maenza J, Lu Y, Wise MC, Yan J, Morrow MP, Khan AS, Boyer JD, Humeau L, White S, Pensiero M, Sardesai NY, Bagarazzi ML, Weiner DB, Ferrari G, Tomaras GD, Montefiori DC, Corey L, McElrath MJ; HIV Vaccine Trials Network (HVTN) 098 Study Team. Robust antibody and cellular responses induced by DNA-only vaccination for HIV. JCI Insight. 2020 Jul 9;5(13):e137079. doi: 10.1172/jci.insight.137079.

    PubMed 32437332

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PENNVAX®-GP HIV-1 DNA vaccine and Interleukin-12 (IL-12) DNA adjuvant in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 36 inclusion and 47 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 4 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 of reactogenicity signs and symptoms (time frame: Measured through Month 18). The study lists 16 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 NCT02431767, which also lists 1 linked publication.

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.

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