NCT03776994

Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine

A Phase 1 Dose Escalation Study to Assess the Safety and Immunogenicity of a Monovalent Virus-Like Particle (VLP) Venezuelan Equine Encephalitis Vaccine in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: SRI International · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

This Phase 1 dose escalation study will evaluate safety and immunogenicity of both non-adjuvanted and adjuvanted VEE VLP vaccine in three dose groups (2 μg, 10 μg, and 20 μg) given as a 2-dose primary series IM injection (Days 0 and Week 4 \[Day 28\]) followed by a booster dose injection (Week 20 \[Day 140\]). Each group will consist of 30 subjects, for a total of 90 study subjects. Each group of 30 subjects will be randomized to receive either non-adjuvanted vaccine (Subgroup A; n=15) or adjuvanted vaccine (Subgroup B; n=15). Subjects will be blinded to receiving the non-adjuvanted versus adjuvanted vaccine, but will not be blinded to the vaccine dosage. Enrollment will utilize a sentinel dose design, with only one subject receiving a vaccine dose the initial day, 2 subjects the following day, and 3 subjects the subsequent day, before proceeding with further enrollments in that group. Subjects in each Group will be randomized to receive the vaccine dose either without adjuvant (Subgroup A) or with adjuvant (Subgroup B).

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

Type	Name	Description
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)

Timeline

• Start date: 2018-07-17
• Primary completion: 2020-07-27
• Completion: 2021-04-01
• First posted: 2018-12-17
• Last updated: 2021-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study