NCT03776994: VEEV

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 1 Last updated 19 February 2021

What this trial tests

Phase 1 trial testing Vaccinations on Day 0, Day 28, and Day 140 in Encephalitis in 48 participants. Status unknown.

Timeline

17 July 2018

Primary endpoint
27 July 2020

1 April 2021

Quick facts

Lead sponsor	SRI International
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	prevention
Enrollment	48
Start date	17 July 2018
Primary completion	27 July 2020
Estimated completion	1 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Vaccinations on Day 0, Day 28, and Day 140 — full drug profile →

Conditions studied

• Encephalitis — all drugs for Encephalitis →
• Encephalitis, Viral — all drugs for Encephalitis, Viral →
• Infectious Encephalitis — all drugs for Infectious Encephalitis →
• Virus Diseases — all drugs for Virus Diseases →

Sponsor

SRI International — full company profile →

Who can join

Adults 18 to 50, any sex, with Encephalitis or Encephalitis, Viral. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of subjects reporting solicited local adverse events
  Time frame: Through the study duration of 44 weeks
  • The solicited local adverse events (SLAEs) are specified and collected in daily diary questionnaires for 1 week after each vaccination in each arm of the study (Days 0-7, 28-35, and 140-147). These SLAEs include pain, tenderness, induration or swelling, and erythema. Symptoms are counted once if subjects experienced the symptom at any severity during the reporting period. The number of local sym
• Number of subjects reporting solicited systemic adverse events
  Time frame: Through the study duration of 44 weeks
  • The solicited systemic adverse events (SSAEs) are specified and collected in daily diary questionnaires for 1 week after each vaccination in each arm of the study (Days 0-7, 28-35, and 140-147). These SSAEs are fever, malaise, myalgia, arthralgia, headache, chills, fever, nausea, and rash. Symptoms are counted once if subjects experienced the symptom at any severity during the reporting period.
• Number of subjects reporting treatment-emergent adverse events
  Time frame: Through the study duration of 44 weeks
  • Unsolicited treatment-emergent adverse events (collected for 28 days after each vaccination or Days 0-28, Days 28-56, and Days 140-168) will be collected and tabulated. MedDRA version 21.0 will be used for coding. The number of subjects experiencing the unsolicited treatment-emergent adverse events within the 28 days after the three vaccinations will be reported for each of the six arms.
• Number of subjects reporting serious adverse events
  Time frame: Through the study duration of 44 weeks
  • Serious adverse events will be collected throughout the study. The frequency of these solicited adverse events will each be expressed as the number of subjects experiencing these adverse events for the three vaccinations within each of the six arms of the study.
• Number of subjects with abnormalities in serum creatinine concentrations
  Time frame: Through the study duration of 44 weeks
  • Serum creatinine is measured on Days 0, 7, 28, 35, 56, 140, 147, 168 and 308. The normal range for adults aged 18-50 years for men is 0.6 - 1.35 mg/dL and women 0.50 - 1.10 mg/dL. The abnormal serum creatinine values are characterized as follows: Grade 1 (1.5 - 1.7 mg/dL), Grade 2 (1.8 - 2.0 mg/dL), Grade 3 (2.1 - 2.5 mg/dL), and grade 4 (\>2.5 mg/dL or requires dialysis) according to the "Toxic
• Number of subjects with abnormal serum alanine aminotransferase concentrations
  Time frame: Through the study duration of 44 weeks
  • Serum alanine aminotransferase is measured on Days 0, 7, 28, 35, 56, 140, 147, 168 and 308.The normal range for adults ages 18-50 years for men is 9 - 46 mg/dL and women 6 - 29 mg/dL. The grading is characterized as follows: Grade 1 (1.1 - 2.5 x upper limits of normal \[ULN\]), Grade 2 (2.6 - 5.0 ULN), Grade 3 (5.1 - 10 x ULN) and Grade 4 (\>10 x ULN) according to the "Toxicity grading scale for

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Platforms, advances, and technical challenges in virus-like particles-based vaccines.
   Gupta R, Arora K, Roy SS, Joseph A, et al · · 2023 · cited 80× · PMID 36845125 · DOI 10.3389/fimmu.2023.1123805
2. Biological Nanoparticles in Vaccine Development.
   Curley SM, Putnam D. · · 2022 · cited 43× · PMID 35402394 · DOI 10.3389/fbioe.2022.867119
3. Developing a Prototype Pathogen Plan and Research Priorities for the Alphaviruses.
   Powers AM, Williamson LE, Carnahan RH, Crowe JE, et al · · 2023 · cited 12× · PMID 37849399 · DOI 10.1093/infdis/jiac326