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

Inclusion Criteria

A volunteer must have met all of the following criteria:

• Age 18 to 50 years
• Available for clinical follow-up through 36 weeks after randomization
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Able and willing to complete the informed consent process
• Willing to donate blood for sample storage to be used for future research
• In good general health, without clinically significant medical history, and has satisfactorily completed screening
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to randomization

Laboratory Criteria within 28 days prior to randomization:

• Hemoglobin within institutional normal range or accompanied by Principal Investigator (PI) or designee approval
• White blood cell (WBC) and differential either within institutional normal range or accompanied by PI or designee approval
• Total lymphocyte count: ≥800 cells/mm3
• Platelets: 125,000-500,000/mm3
• Alanine aminotransferase (ALT): ≤ 1.25 x upper limit of normal range
• Serum creatinine: ≤1.1 x upper limit of normal
• Negative for HIV infection by an FDA-approved method of detection

Criteria applicable to women of childbearing potential:

• Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of randomization before receiving the study product
• Agrees to use an effective method of birth control, if sexually active, from at least 21 days prior to randomization through the last study visit.

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
• An