Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03776994
Status:
UNKNOWN
Last Update Posted:
2021-02-23
First Post:
2018-11-07
Brief Title:
Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine
Sponsor:
SRI International
Organization:
SRI International
Study Overview
Official Title:
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
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
VEEV
Brief 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 n15 or adjuvanted vaccine Subgroup B n15 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
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?:
None