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

Exclusion Criteria

• •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
• •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 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