VRC 313: A Trivalent Virus-like Particle (VLP) Encephalitis Vaccine (WEVEE) in Healthy Adults

Exclusion Criteria

• •A volunteer was excluded if one or more of the following conditions applied:
• •Female-Specific Criteria
• •Breast-feeding or planning to become pregnant while participating in the study
• •Volunteer received any of the following:
• •More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to randomization or any within the 14 days prior to randomization
• •Blood products within 16 weeks prior to randomization
• •Immunoglobulin within 8 weeks prior to randomization
• •Prior vaccinations with an investigational alphavirus vaccine
• •Investigational research agents within 4 weeks prior to randomization or planning to receive investigational products while on study
• •Live attenuated vaccines within 4 weeks prior to randomization
• •Inactivated vaccines within 2 weeks prior initial study vaccine administration unless approved by the PI
• •Current anti-tuberculosis (TB) prophylaxis or therapy
• •Volunteer has a history of any of the following clinically significant conditions:
• •A history of confirmed or suspected viral encephalitis infection
• •Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
• •Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
• •Asthma that is not well controlled
• •Diabetes mellitus (type I or type II) with the exception of gestational diabetes
• •Thyroid disease that is not well controlled
• •Hypertension that is not well controlled
• •Evidence of autoimmune disease or immunodeficiency
• •Idiopathic urticaria within the last year
• •Malignancy that is active or history of malignancy that is likely to recur during the study
• •Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular (IM) product administration or blood draws
• •Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures or treatment for a seizure disorder within the last 3 years
• •Asplenia, functional asplenia or any condition resulting in absence or removal of the spleen
• •Psychiatric condition that precludes compliance with the protocol; past or present psychoses; or within 5 years prior to randomization, a history of suicide plan or attempt
• •Any other chronic or clinically significant medical, psychiatric or social condition that, in the judgement of the investigator is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.