New vaccine could stop deadly lassa fever
NCT ID NCT06546709
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new vaccine called LASSARAB, designed to protect against Lassa fever, a serious viral illness. The vaccine uses a modified rabies virus to deliver the Lassa antigen and includes an adjuvant to boost the immune response. 55 healthy adults will receive two doses to see if it is safe and triggers an immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LASSARAB vaccine (rabies-vectored Lassa fever vaccine with aPHAD-SE adjuvant)
- What this could lead to
- If successful, this could pave the way for a vaccine to prevent Lassa fever, a serious viral disease common in West Africa.
- What could go wrong
- This is a very early (Phase 1) trial with only 55 people, so it's primarily checking safety. The vaccine may not trigger a strong enough immune response or could cause side effects. Success in animals doesn't guarantee it will work in humans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provides written informed consent prior to the initiation of any trial procedures. 2. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits. 3. Age ≥ 18 and ≤50 years at time of enrollment. 4. In good general health and without clinically significant medical, psychiatric, chronic or intermittent health conditions including those listed in Exclusion Criteria 5. 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. 6. 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). 7. Vital signs and Body Mass Index (BMI) are in the following ranges at screening: * Oral temperature is less than 100.4°F (38.0°C). * Pulse is 47 to 100 beats per minute, inclusive. * Systolic blood pressure (SBP) is 85 to 140 mmHg, inclusive. * Diastolic blood pressure(DBP) is 55 to 90 mmHg, inclusive. * BMI of 18 kilograms/square meter (kg/m2) (inclusive) to \<35 kg/m2 8. 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. 9. Has a negative rabies neutralizing antibody test at screening (\< 0.5 IU/mL in RFFIT assay) 10. Screening hematology tests (white blood cells, hemoglobin, and platelets) and screening chemistry tests (alanine transaminase, creatine, and total bilirubin) are within acceptable parameters 11. Must agree to the collection and storage of residual biological specimens and additional clinical specimens for secondary research use 12. Agreement to adhere to Lifestyle Considerations during the study Exclusion Criteria: 1. A history of anaphylaxis, serum sickness, meningitis; neuroparalytic events such as encephalitis, transient paralysis; Guillain-Barré Syndrome; myelitis; retrobulbar neuritis; history of prior or current hearing loss as assessed by quantitative audiometry; or multiple sclerosis 2. Current use of any medications that may be associated with impaired immune responsiveness 3. Allergy treatment with antigen injections within 60 days before first vaccination or that are planned through the end of the study. 4. Receipt of immunoglobulins and/or any blood products within the 60 days before first vaccination or that are planned through the end of the study. 5. Current pregnancy or lactation 6. Known allergic reactions to 1) any rabies vaccine; 2) any components of HDCV (human albumin, neomycin sulfate, phenol red, beta-propiolactone); 3) any components of LASSARAB +aPHAD-SE (LASSARAB, Tris-HCI, L-Arginine, (3D -(6-Acyl) PHAD, Squalene Redistilled, DMPC, Vitamin E Dry Powder). 7. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions to drug or vaccine products. 8. Has a significant acute illness (with or without fever), as determined by the site PI or appropriate sub-investigator, within 72 hours prior to enrollment 9. Receipt of a rabies vaccine or an antibody therapeutic product for treating rabies or a Lassa fever vaccine any time before the first planned study vaccination. 10. Receipt of another experimental agent or intervention within 60 days before first vaccination or plans to do so before the end of the study. 11. Received or plans to receive any other vaccine in the 2 weeks prior to the first vaccination through Day 61 (32 days after the last study treatment). 12. Received or plans to receive any live vaccine in the 4 weeks prior to first vaccination through Day 61 (32 days after the last study treatment). 13. Self-reported or known history of alcoholism within the last 2 years. 14. Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety or endpoint assessment. 15. Has tattoos, scars, or other marks which would, in the opinion of the investigator, interfere with assessment of the vaccination site.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.