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Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine

NCT03776994 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-02-23

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection at escalating doses of 2 μg, 10 μg, and 20 μg as a 2-dose primary series (Day 0, Day 28) with a Day 140 booster dose. The secondary objective of the study is to evaluate immunogenicity of the vaccine at the aforementioned time points

Conditions

  • Encephalitis
  • Encephalitis, Viral
  • Infectious Encephalitis
  • Virus Diseases
  • Encephalomyelitis, Venezuelan Equine
  • Brain Diseases
  • Central Nervous System Diseases
  • Central Nervous System Viral Diseases
  • Alphavirus Infections
  • Togaviridae Infections
  • RNA Virus Infections
  • Central Nervous System Infections
  • Encephalomyelitis
  • Physiological Effects of Drugs
  • Vaccines
  • Encephalomyelitis, Equine
  • Nervous System Diseases

Interventions

BIOLOGICAL

Vaccinations on Day 0, Day 28, and Day 140

The monovalent VEE VLP vaccine (the same VEE VLP study agent which comprises the VEE portion of the NIAID trivalent alphaviral VLP vaccine) will use the same vaccination regimen (Day 0, Week 4 \[Day 28\], and Week 20 \[Day 140\]) and the vaccine dosages (2 μg, 10 μg, and 20 μg)

Sponsors & Collaborators

  • US Army Medical Research Institute of Infectious Diseases

    collaborator FED

  • SRI International

    lead INDUSTRY

Principal Investigators

  • Sascha Goonewardena, MD · SRI International

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2020-07-27
Completion
2021-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03776994 on ClinicalTrials.gov