Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205

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
• •Volunteer has 2 or more of the following cardiac risk factors:
• •* Participant report of history of elevated blood cholesterol defined as fasting LDL greater than 160 mg/dL;
• •* First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
• •* Current smoker; or
• •* BMI greater than or equal to 35
• •Pregnant or breastfeeding
• •Active duty and reserve U.S. military personnel
• •Vaccines and Other Injections
• •Any clinically significant AE related to vaccination in HVTN 205, for which revaccination would be a safety concern such as any grade 3 or 4 related AE
• •Smallpox vaccine received within the last 5 years
• •HIV vaccine(s) received in a prior HIV vaccine trial other than HVTN 205. For HVTN 205 participants who have subsequently received control/placebo in another HIV vaccine trial, the HVTN 114 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 volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 114 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 114 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 (eg, 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 (eg, 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 exclusionary: \[1\] corticosteroid nasal spray; \[2\] 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 or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
• •Hypersensitivity to eggs or egg products
• •Immunoglobulin received within 60 days before first vaccination
• •Autoimmune disease (eg, myositis)
• •Immunodeficiency
• •Cardiac
• •History of myocarditis, pericarditis, cardiomyopathy, congestive heart failure with permanent sequelae, clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
• •ECG with clinically significant findings, or features that would interfere with the assessment of myo/pericarditis, as determined by a contract ECG Lab or cardiologist, including any of the following: (1) conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS greater than or equal to 120 ms, PR interval greater than or equal to 220ms, any 2nd or 3rd degree AV block, or QTc prolongation (greater than 450ms)); (2) repolarization (ST segment or T wave) abnormality that will interfere with the assessment of myo/pericarditis; (3) significant atrial or ventricular arrhythmia; (4) frequent atrial or ventricular ectopy (eg, frequent premature atrial contractions, 2 premature ventricular contractions in a row); (5) ST elevation consistent with ischemia; (6) evidence of past or evolving myocardial infarction
• •Clinically Significant Medical Conditions
• •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. A clinically significant condition or process includes but is not limited to:
• •* A process that would affect the immune response,
• •* A process that would require medication that affects the immune response,
• •* Any contraindication to repeated injections or blood draws,
• •* A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
• •* A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
• •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 volunteer's ability to give informed consent
• •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 (TB) 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 (NAEPP) Expert Panel report).
• •* Exclude a volunteer 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:
• •* Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
• •* 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 volunteers, 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 (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• •Malignancy (Not excluded from participation: Volunteer 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 3 years. Also exclude if volunteer 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.