DMID 23-0015; Lassa Fever CVD 1000
NCT Number: NCT06546709
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Lassa Fever
Interventions: BIOLOGICAL: LASSARAB+ aPHAD-SEat 700rU|BIOLOGICAL: HDCV Comparator|OTHER: Normal Saline Placebo|BIOLOGICAL: LASSARAB+ aPHAD-SEat 1400rU
Sponsor: Wilbur Chen, MD, MS
Sex: ALL
Age: ADULT
Enrollment: 55
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-03

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.

Primary Outcome Measures: Number of participants experiencing solicited local and systemic events, Number of participants experiencing solicited local and systemic reactogenicity Adverse Events (AEs), From Day 1 through Day 8 for the first vaccination and from Day 29 through Day 36 for the second vaccination, as applicable|Percentage of participants experiencing solicited local and systemic events, Percentage of participants experiencing solicited local and systemic reactogenicity Adverse Events (AEs), From Day 1 through Day 8 for the first vaccination and from Day 29 through Day 36 for the second vaccination, as applicable|Number of participants experiencing unsolicited events, Number of participants experiencing any unsolicited AEs, Day 1 through Day 61|Percentage of participants experiencing unsolicited events, Percentage of participants experiencing any unsolicited AEs, Day 1 through Day 61|Number of participants experiencing Serious Adverse Events (SAEs), Number of participants experiencing SAEs, Day 1 through Day 394|Percentage of participants experiencing Serious Adverse Events (SAEs), Percentage of participants experiencing SAEs, Day 1 through Day 394|Number of participants experiencing Medically-Attended Adverse Events (MAAEs), Number of participants experiencing MAAEs, Day 1 through Day 394|Percentage of participants experiencing Medically-Attended Adverse Events (MAAEs), Percentage of participants experiencing MAAEs, Day 1 through Day 394|Number of participants experiencing New-Onset Chronic Medical Conditions (NOCMCs), Number of participants experiencing NOCMCs, Day 1 through Day 394|Percentage of participants experiencing New-Onset Chronic Medical Conditions (NOCMCs), Percentage of participants experiencing NOCMCs, Day 1 through Day 394|Number of participants experiencing Potential Immune-Mediated Medical Conditions (PIMMCs), Number of participants experiencing PIMMCs, Day 1 through Day 394|Percentage of participants experiencing Potential Immune-Mediated Medical Conditions (PIMMCs), Percentage of participants experiencing PIMMCs, Day 1 through Day 394|Number of participants experiencing Adverse Event of Special Interest (AESI), Number of participants experiencing Adverse Event of Special Interest (AESI) - new onset sensorineural hearing loss (SNHL), Day 1 through Day 394|Percentage of participants experiencing Adverse Event of Special Interest (AESI), Percentage of participants experiencing Adverse Event of Special Interest (AESI) - new onset sensorineural hearing loss (SNHL), Day 1 through Day 394|Number of participants experiencing clinical laboratory AEs, Number of participants experiencing clinical laboratory AEs, Day 1 through Day 61|Percentage of participants experiencing clinical laboratory AEs, Percentage of participants experiencing clinical laboratory AEs, Day 1 through Day 61