Evaluating an Ebola and a Marburg Vaccine in Uganda

This is an interventional prevention trial for Ebola Virus Disease focused on measuring Vaccine Read More

Inclusion Criteria:

• Available for clinical follow-up through Week 104
• Willing to have photo taken for identification purposes
• Willing to be taken home at enrollment visit and allow home visits if appointments are not kept
• Completes an Assessment of Understanding (AoU) prior to enrollment by answering 9 out of 10 questions at least once in 3 attempts
• In good general health without clinically significant medical history
• Has a physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment
• Female participants of reproductive potential must have a negative result on a human choriogonadotropin (β-HCG) pregnancy test
• Female participants must either be incapable of becoming pregnant or agree to take appropriate precautions that pregnancy will not occur during the first 24 weeks of the study

Exclusion Criteria:

• Pregnant, breast-feeding, or planning to become pregnant during the first 24 weeks after enrollment
• History of Ebola or Marburg virus exposure
• Occupational health risk of exposure to the Ebola or Marburg virus known to be higher than that of the general population

• Has received any of the following substances:

  • Investigational Ebola or Marburg vaccine in a prior clinical trial
  • Blood products within 120 days prior to HIV screening
  • Immunoglobulin within 60 days of prior to HIV screening
  • Live attenuated vaccines within 30 days prior to initial study vaccine administration
  • Investigational research agents within 30 days prior to initial study vaccine administration
  • Medically indicated subunit or killed vaccines (such as influenza, pneumococcal, or allergy treatment with antigen injections) within 14 days of study vaccine administration
  • Current anti-tuberculosis prophylaxis or therapy
  • Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within 12 weeks of enrollment, except in the following cases: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroids for a non-chronic condition (based on investigator clinical judgement) at least 2 weeks prior to enrollment in this study
• History of serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
• Presence of idiopathic urticaria within the past 2 years
• History of autoimmune disease or immunodeficiency
• History of unstable asthma; asthma that required emergent care, urgent care, hospitalization or intubation during the past 2 years; or asthma that requires the use of oral or parenteral corticosteroids
• History of diabetes mellitus (type I or II), with the exception of a history of gestational diabetes
• History of thyroidectomy or thyroid disease that required medication within the past 12 months
• History of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema
• History of hypertension that is not well controlled by medication or blood pressure that is more than 145/95 mm Hg at enrollment
• Presence of a bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with intramuscular injections or blood draws, or routine use of anticoagulant medications
• Presence of active malignancy, 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
• History of a seizure or seizure disorder
• Asplenia, functional asplenia, or any condition resulting in the absence or removal of the spleen
• Allergic reaction to aminoglycoside antibiotics
• Presence of a psychiatric condition that precludes compliance with the protocol
• History of psychoses, bipolar disorder, disorder requiring lithium, or suicide plan or attempt within 5 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 subject's ability to give informed consent
• Evidence of syphilis based on history, exam, and rapid plasma reagin (RPR) test results