VRC 313: A Trivalent Virus-like Particle (VLP) Encephalitis Vaccine (WEVEE) in Healthy Adults
Condition: Venezuelan Equine Encephalitis; Western Equine Encephalitis; Eastern Equine Encephalitis; Alphavirus Infections
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Venezuelan Equine; Encephalomyelitis, Eastern Equine; Encephalomyelitis, Western Equine; Alphavirus Infections; Encephalitis
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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 were 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 was randomized
      and vaccinated per day for the first 3 subjects at each dose. If the 6 mcg dose of WEVEE was
      assessed as not showing safety concerns by a Protocol Safety Review Team (PSRT),
      randomization began for Groups 3 and 4 (30 mcg WEVEE without alum and with alum,
      respectively). In a second safety review conducted on the first 3 subjects to receive 30 mcg,
      if the 30 mcg dose of WEVEE was assessed as not showing safety concerns by the PSRT,
      randomization began for Groups 5 and 6 (60 mcg WEVEE without and with alum, respectively).

      The product was 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 was evaluated using a 7-day diary card. Assessment
      of vaccine safety included clinical observation and monitoring of hematological and chemical
      parameters at clinical visits throughout the study.
    

Intervention name(s): VRC-WEVVLP073-00-VP; VRC-GENMIX083-AL-VP
Intervention type(s): Biological; Other
Intervention description(s): VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP); VRC-GENMIX083-AL-VP is an adjuvant
Other intervention name(s): WEVEE; Aluminum Hydroxide Suspension; Alum
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects were randomized into:
WEVEE vaccine alone (Group 1, Group 3, and Group 5) or, WEVEE vaccine mixed with alum (Group 2, Group 4, and Group 6, respectively).
The study started by randomizing subjects to get a dose of 6 mcg in Group 1 or Group 2. Safety data were reviewed after 2 weeks to make sure this vaccine dose had no safety concerns before subjects were randomized to get the next dose of 30 mcg in Group 3 or Group 4. Safety data were reviewed again to make sure the 30 mcg vaccine dose had no safety concerns before subjects were randomized to the 60 mcg dose in Group 5 or Group 6.
A total of 30 subjects were randomized among the 6 groups.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Alphavirus; VEE; WEE; EEE; Vaccine; Virus-like particles