HIV-1 Vaccine Booster in Previously Immunized Uninfected Adult Volunteers

Exclusion Criteria

• •A volunteer will be excluded if one or more of the following conditions apply:
• •Women:
• •Breast-feeding or planning to become pregnant during the 24 weeks of study participation.
• •Volunteer has received any of the following substances:
• •Immunosuppressive or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis).
• •Blood products within 120 days prior to HIV screening.
• •Immunoglobulin within 60 days prior to HIV screening.
• •Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• •Investigational research agents within 30 days prior to study vaccine administration.
• •Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
• •Current anti-TB prophylaxis or therapy.
• •Volunteer has a history of any of the following clinically significant conditions:
• •Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• •Autoimmune disease or immunodeficiency.
• •Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
• •Diabetes mellitus (type I or II), with the exception of gestational diabetes.
• •History of thyroidectomy or thyroid disease that required medication within the past 12 months.
• •Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
• •Hypertension that is not well-controlled by medication or is more than 145/95 at enrollment.
• •Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
• •Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.
• •Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
• •Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.
• •Asplenia or any condition resulting in the absence or removal of the spleen.
• •Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.
• •Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.