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

Completed · Phase 1

Conditions studied: Venezuelan Equine Encephalitis, Western Equine Encephalitis, Eastern Equine Encephalitis, Alphavirus Infections

In brief

Western Equine Encephalitis Virus (WEEV), Eastern Equine Encephalitis Virus (EEEV), and Venezuelan Equine Encephalitis Virus (VEEV) are transmitted to humans by infected mosquitoes and can cause encephalitis (swelling of the brain) and other neurological manifestations, including fever, chills, discomfort, feeling sick, muscle pain and then headache, vomiting, restlessness, irritability, seizures, coma, and death. Vaccines teach the body to prevent or fight an infection. When the body learns to fight an infection, this is called an immune response. Researchers developed a vaccine against Western, Eastern and Venezuelan equine encephalitis viruses to help the body make an immune response. There are no live or killed viruses in the vaccine, so you cannot get infected with any of these 3 viruses from getting the vaccine. The experimental trivalent encephalitis vaccine, VRC-WEVVLP073-00-VP, is composed of Western equine encephalitis (WEE), Eastern equine encephalitis (EEE), and Venezuelan equine encephalitis (VEE) virus-like particles (VLP). The purpose of this study is to test three doses (6 mcg, 30 mcg, and 60 mcg) of this experimental vaccine against Western, Eastern and Venezuelan equine encephalitis viruses.

Key facts

Study ID

NCT03879603

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Starts

2019-04-02

Expected to finish

2020-02-26

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Hope Clinic of the Emory Vaccine Center — Decatur, Georgia, United States

Full record on ClinicalTrials.gov

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