Antigenic Competition in HIV Preventive Vaccines

Exclusion Criteria

• •Within the 12 months prior to enrollment: excessive daily alcohol use, frequent binge drinking, chronic marijuana abuse, or any other use of illicit drugs
• •Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B virus
• •Received non-HIV experimental vaccine(s) 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 the control or placebo in an experimental vaccine trial, the HVTN 084 PSRT will determine eligibility on a case-by-case basis.
• •For potential participants who received the control or placebo in an HIV vaccine trial, documentation of the identity of the study control or placebo must be provided to the HVTN 084 protocol safety review team (PSRT), who will determine eligibility on a case-by-case basis.
• •Serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A participant who had a nonanaphylactic adverse reaction to pertussis vaccine as a child will not be excluded.
• •Immunosuppressive medications received within 168 days before first vaccination, except (1) corticosteroid nasal spray for allergic rhinitis, (2) topical corticosteroids for mild, uncomplicated dermatitis, or (3) oral or 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 vaccination or scheduled within 14 days after injection (e.g., measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever)
• •Influenza vaccines or any vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, hepatitis A or B), or allergy treatment with antigen injections that were received within 14 days prior to the vaccination
• •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 study
• •Current anti-tuberculosis (TB) prophylaxis or therapy
• •Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history with implications for current health.
• •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
• •Angioedema (hereditary, acquired, or idiopathic) or idiopathic urticaria within the last 3 years if episodes are considered serious or have required medication within the last 2 years
• •Autoimmune disease
• •Immunodeficiency
• •Untreated or incompletely treated syphilis infection
• •Asthma other than mild, well-controlled asthma
• •Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. History of isolated gestational diabetes does not mandate exclusion.
• •Thyroidectomy, or thyroid disease requiring medication during the last 12 months
• •Body mass index (BMI) greater than or equal to 40
• •Hypertension that is not well controlled
• •Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• •Malignancy. 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.
• •Seizure disorder. Not excluded: a participant with a history of seizures who has not required medications or had a seizure within the past 3 years.
• •Asplenia, defined as any condition resulting in the absence of a functional spleen
• •Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, persons at ongoing risk for suicide, or persons with a history of suicide attempt or gesture within the past 3 years.
• •Pregnant or breastfeeding
• •Has been fully circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed