Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-27 @ 10:04 PM
Study NCT ID:
NCT03483961
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2018-03-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Sponsor:
Bavarian Nordic
Organization:
Study Overview
Official Title:
A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
Detailed Description:
The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: