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 range

18 Years – 50 Years

Sex

ALL

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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 range

18 Years – 50 Years

Sex

ALL

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).

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)