Active — Not RecruitingPhase 1

DMID 23-0015; Lassa Fever CVD 1000

United States55 participantsStarted 2025-01-13

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provides written informed consent prior to the initiation of any trial procedures.
✓. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
✓. Age ≥ 18 and ≤50 years at time of enrollment.

Exclusion criteria

✕. Participants of childbearing potential must have a negative serum human chronic gonadotropin (HCG) pregnancy test at screening and a negative urine HCG pregnancy test within 24 hours prior to the study vaccination.
✕. Participants of childbearing potential in a heterosexual relationship agree to use of highly effective contraception beginning at the time of the screening visit through Day 61 (32 days after the last study treatment).
✕. Vital signs and Body Mass Index (BMI) are in the following ranges at screening:
✕. Has a negative test result for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
✕

What they're measuring

Number of participants experiencing solicited local and systemic events

Timeframe: 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

Timeframe: 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

Timeframe: Day 1 through Day 61

Percentage of participants experiencing unsolicited events

Timeframe: Day 1 through Day 61

Number of participants experiencing Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 394

Percentage of participants experiencing Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 394

Number of participants experiencing Medically-Attended Adverse Events (MAAEs)

Timeframe: Day 1 through Day 394

Trial details

NCT IDNCT06546709

SponsorWilbur Chen, MD, MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Lassa Fever trials

Plain-language summary

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provides written informed consent prior to the initiation of any trial procedures.
✓. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.
✓. Age ≥ 18 and ≤50 years at time of enrollment.

Exclusion criteria

✕. Participants of childbearing potential must have a negative serum human chronic gonadotropin (HCG) pregnancy test at screening and a negative urine HCG pregnancy test within 24 hours prior to the study vaccination.
✕. Participants of childbearing potential in a heterosexual relationship agree to use of highly effective contraception beginning at the time of the screening visit through Day 61 (32 days after the last study treatment).
✕. Vital signs and Body Mass Index (BMI) are in the following ranges at screening:
✕. Has a negative test result for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
✕

What they're measuring

Number of participants experiencing solicited local and systemic events

Timeframe: 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

Timeframe: 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

Timeframe: Day 1 through Day 61

Percentage of participants experiencing unsolicited events

Timeframe: Day 1 through Day 61

Number of participants experiencing Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 394

Percentage of participants experiencing Serious Adverse Events (SAEs)

Timeframe: Day 1 through Day 394

Number of participants experiencing Medically-Attended Adverse Events (MAAEs)

Timeframe: Day 1 through Day 394