Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546709
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
DMID 23-0015 Lassa Fever CVD 1000
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Recipient- and Observer-Blinded Dose-Escalation Study to Evaluate the Safety Reactogenicity and Immunogenicity of Two Doses of Rabies-Vectored Monovalent Lassa Fever Vaccine LASSARAB Administered With 3D-6-Acyl PHAD-SE aPHAD-SE Adjuvant in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study proposes the evaluation of a novel first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex GPC antigen The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein GP antigen and the Lassa GPC The inactivated chimeric virus is delivered with a toll-like receptor TLR-4-activating oil-in-water emulsion adjuvant Studies using this vaccine administered as a prime-boost series in mice and non-human primates and then challenged with Lassa virus demonstrated significant protection against Lassa fever Given that the vaccine backbone is an attenuated and inactivated rabies virus expressing rabies GP this vaccine will also be evaluated for immunogenicity against rabies virus
Detailed Description:
Lassa fever is a zoonotic infection endemic in West Africa and is spread by the Lassa virus an arenavirus causing hemorrhagic fever Up to 300000 Lassa fever infections occur annually and while disease is often mild in a subset of individuals disease is characterized by severe anemia bleeding encephalopathy respiratory failure shock and high mortality In some regions of West Africa up to 15 of hospital admissions are secondary to Lassa fever and an estimated 5000 deaths occur annually During epidemics of disease case-fatality rates may reach as high as 50 in hospitalized patients Approximately one-third of infected individuals will develop hearing loss regardless of disease severity and in a proportion of patients permanent deafness occurs
Prevention of illness through vaccination is a critical goal in reducing the burden of disease from Lassa fever There are currently no vaccines or therapeutics demonstrated to be efficacious in the prevention or treatment of Lassa fever This study proposes the evaluation of a novel first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex GPC antigen The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein GP antigen and the Lassa GPC The inactivated chimeric virus is delivered with a toll-like receptor TLR-4-activating oil-in-water emulsion adjuvant Studies using this vaccine administered as a prime-boost series in mice and non-human primates and then challenged with Lassa virus demonstrated significant protection against Lassa fever Given that the vaccine backbone is an attenuated and inactivated rabies virus expressing rabies GP this vaccine will also be evaluated for immunogenicity against rabies virus
Prevention of illness through vaccination is a critical goal in reducing the burden of disease from Lassa fever There are currently no vaccines or therapeutics demonstrated to be efficacious in the prevention or treatment of Lassa fever This study proposes the evaluation of a novel first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex GPC antigen The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein GP antigen and the Lassa GPC The inactivated chimeric virus is delivered with a toll-like receptor TLR-4-activating oil-in-water emulsion adjuvant Studies using this vaccine administered as a prime-boost series in mice and non-human primates and then challenged with Lassa virus demonstrated significant protection against Lassa fever Given that the vaccine backbone is an attenuated and inactivated rabies virus expressing rabies GP this vaccine will also be evaluated for immunogenicity against rabies virus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None