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

2019-03-22 06:26:19 | BioPortfolio

Summary

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.

Description

This is a Phase 1, randomized, open-label, dose-escalation study to examine the safety, tolerability, and immune response of three doses (6 mcg, 30 mcg, and 60 mcg) of the WEVEE vaccine (VRC-WEVVLP073-00-VP) alone or with alum adjuvant (VRC-GENMIX083-AL-VP) in a 2-product administration regimen.

Eligible subjects will be randomized to WEVEE alone (Groups 1, 3, and 5) or WEVEE plus alum (Groups 2, 4, and 6, respectively) in each dose group. No more than 1 subject will be randomized and vaccinated per day for the first 3 subjects at each dose. If the 6 mcg dose of WEVEE is assessed as not showing safety concerns by a Protocol Safety Review Team (PSRT), randomization will begin for Groups 3 and 4 (30 mcg WEVEE without alum and with alum, respectively). A second safety review will be conducted on the first 3 subjects to receive 30 mcg and if the 30 mcg dose of WEVEE is assessed as not showing safety concerns by the PSRT, randomization will begin for Groups 5 and 6 (60 mcg WEVEE without and with alum, respectively).

The product will be administered in the upper arm muscle as an intramuscular (IM) injection via needle and syringe at Day 0 and 8 weeks later.

For all Groups, solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.

Study Design

Conditions

Venezuelan Equine Encephalitis

Intervention

VRC-WEVVLP073-00-VP, VRC-GENMIX083-AL-VP

Location

The Hope Clinic of the Emory Vaccine Center
Decatur
Georgia
United States
30030

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-03-22T06:26:19-0400

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Medical and Biotech [MESH] Definitions

A form of arboviral encephalitis endemic to Central America and the northern latitudes of South America. The causative organism (ENCEPHALITIS VIRUS, VENEZUELAN EQUINE) is transmitted to humans and horses via the bite of several mosquito species. Human viral infection may be asymptomatic or remain restricted to a mild influenza-like illness. Encephalitis, usually not severe, occurs in a small percentage of cases and may rarely feature SEIZURES and COMA. (From Joynt, Clinical Neurology, 1996, Ch26, pp9-10)

A species of ALPHAVIRUS that is the etiologic agent of encephalomyelitis in humans and equines. It is seen most commonly in parts of Central and South America.

A form of arboviral encephalitis (primarily affecting equines) endemic to eastern regions of North America. The causative organism (ENCEPHALOMYELITIS VIRUS, EASTERN EQUINE) may be transmitted to humans via the bite of AEDES mosquitoes. Clinical manifestations include the acute onset of fever, HEADACHE, altered mentation, and SEIZURES followed by coma. The condition is fatal in up to 50% of cases. Recovery may be marked by residual neurologic deficits and EPILEPSY. (From Joynt, Clinical Neurology, 1996, Ch26, pp9-10)

A subgroup of the genus FLAVIVIRUS which comprises a number of viral species that are the etiologic agents of human encephalitis in many different geographical regions. These include Japanese encephalitis virus (ENCEPHALITIS VIRUS, JAPANESE), St. Louis encephalitis virus (ENCEPHALITIS VIRUS, ST. LOUIS), Murray Valley encephalitis virus (ENCEPHALITIS VIRUS, MURRAY VALLEY), and WEST NILE VIRUS.

Gonadotropins secreted by the pituitary or the placenta in horses. This term generally refers to the gonadotropins found in the pregnant mare serum, a rich source of equine CHORIONIC GONADOTROPIN; LUTEINIZING HORMONE; and FOLLICLE STIMULATING HORMONE. Unlike that in humans, the equine LUTEINIZING HORMONE, BETA SUBUNIT is identical to the equine choronic gonadotropin, beta. Equine gonadotropins prepared from pregnant mare serum are used in reproductive studies.

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