Lassa FeverPhase 1NCT06546709
DMID 23-0015; Lassa Fever CVD 1000
A Phase 1 study testing LASSARAB+ aPHAD-SEat 700rU, HDCV Comparator and LASSARAB+ aPHAD-SEat 1400rU in people with Lassa Fever, run by Wilbur Chen, MD, MS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lassa Fever
- What is being tested?
- LASSARAB+ aPHAD-SEat 700rU, HDCV Comparator and LASSARAB+ aPHAD-SEat 1400rU
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 11 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- In good general health and without clinically significant medical, psychiatric, chronic or intermittent health conditions including those listed in 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).
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- 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
- 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.
- Has a negative rabies neutralizing antibody test at screening (< 0.5 IU/mL in RFFIT assay)
- Screening hematology tests (white blood cells, hemoglobin, and platelets) and screening chemistry tests (alanine transaminase, creatine, and total bilirubin) are within acceptable parameters
- Must agree to the collection and storage of residual biological specimens and additional clinical specimens for secondary research use
- Agreement to adhere to Lifestyle Considerations during the study
Who cannot join
- 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
- Current use of any medications that may be associated with impaired immune responsiveness
- Allergy treatment with antigen injections within 60 days before first vaccination or that are planned through the end of the study.
- 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.
- Current pregnancy or lactation
- 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).
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- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions to drug or vaccine products.
- 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
- 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.
- Receipt of another experimental agent or intervention within 60 days before first vaccination or plans to do so before the end of the study.
- 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).
- 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).
- Self-reported or known history of alcoholism within the last 2 years.
- Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety or endpoint assessment.
- Has tattoos, scars, or other marks which would, in the opinion of the investigator, interfere with assessment of the vaccination site.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
About this study
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
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.
Read the 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 300,000 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 5,000 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.
- Conditions
- Lassa Fever
- Being tested
- LASSARAB+ aPHAD-SEat 700rU, HDCV Comparator, Normal Saline Placebo, LASSARAB+ aPHAD-SEat 1400rU
- Keywords
- Lassa
- Medical subject headings
- Lassa Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASSARAB+ aPHAD-SEat 700rUBiological
Rabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) with 3D-(6- acyl) Phosphorylated Hexaacyl Disaccharides (PHAD)-Stable squalene oil-in-water nanoemulsion (aPHAD-SE) adjuvant administered by IM injection
HDCV ComparatorBiological
Also called Imovax
Sterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M
Normal Saline PlaceboOther
Sterile 0.9% sodium chloride for injection, USP, or normal saline, is a sterile, nonpyrogenic, isotonic solution; each mL contains sodium chloride 9 mg
LASSARAB+ aPHAD-SEat 1400rUBiological
Rabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) with 3D-(6- acyl) Phosphorylated Hexaacyl Disaccharides (PHAD)-Stable squalene oil-in-water nanoemulsion (aPHAD-SE) adjuvant administered by IM injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - LASSARAB+ aPHAD-SE Vaccine at 700rU or Active Comparator (AC) | Experimental | 4:1 randomization to investigational vaccine or active comparator (n=5) Receives: Biological: LASSARAB+ aPHAD-SEat 700rU; Biological: HDCV Comparator |
| Cohort 2 - LASSARAB+ aPHAD-SE Vaccine at 700rU or 1400rU or AC | Experimental | 11:4:3 randomization to investigational vaccine dose 700rU or 1400rU or active comparator (n=18) Receives: Biological: LASSARAB+ aPHAD-SEat 700rU; Biological: HDCV Comparator; Biological: LASSARAB+ aPHAD-SEat 1400rU |
| Cohort 3 - LASSARAB+ aPHAD-SE Vaccine at 1400rU Single or Double or AC or AC/Placebo | Experimental | 11:2:4:1 randomization to investigational vaccine single dose at 1400rU or investigational vaccine (2 doses) at 14rU or active comparator or active comparator and normal saline placebo Receives: Biological: HDCV Comparator; Other: Normal Saline Placebo; Biological: LASSARAB+ aPHAD-SEat 1400rU |
| Cohort 4 - LASSARAB+ aPHAD-SE Vaccine at 1400rU (single) or AC/Placebo | Experimental | 11:3 randomization to investigational vaccine (2 doses) at 14rU or active comparator and normal saline placebo Receives: Biological: HDCV Comparator; Other: Normal Saline Placebo; Biological: LASSARAB+ aPHAD-SEat 1400rU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing solicited local and systemic events
Number of participants experiencing solicited local and systemic reactogenicity Adverse Events (AEs)
Measured: 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)
Measured: 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
Measured: Day 1 through Day 61
Percentage of participants experiencing unsolicited events
Percentage of participants experiencing any unsolicited AEs
Measured: Day 1 through Day 61
Number of participants experiencing Serious Adverse Events (SAEs)
Number of participants experiencing SAEs
Measured: Day 1 through Day 394
Percentage of participants experiencing Serious Adverse Events (SAEs)
Percentage of participants experiencing SAEs
Measured: Day 1 through Day 394
Number of participants experiencing Medically-Attended Adverse Events (MAAEs)
Number of participants experiencing MAAEs
Measured: Day 1 through Day 394
Percentage of participants experiencing Medically-Attended Adverse Events (MAAEs)
Percentage of participants experiencing MAAEs
Measured: Day 1 through Day 394
Number of participants experiencing New-Onset Chronic Medical Conditions (NOCMCs)
Number of participants experiencing NOCMCs
Measured: Day 1 through Day 394
Percentage of participants experiencing New-Onset Chronic Medical Conditions (NOCMCs)
Percentage of participants experiencing NOCMCs
Measured: Day 1 through Day 394
Number of participants experiencing Potential Immune-Mediated Medical Conditions (PIMMCs)
Number of participants experiencing PIMMCs
Measured: Day 1 through Day 394
Percentage of participants experiencing Potential Immune-Mediated Medical Conditions (PIMMCs)
Percentage of participants experiencing PIMMCs
Measured: 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)
Measured: 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)
Measured: Day 1 through Day 394
Number of participants experiencing clinical laboratory AEs
Number of participants experiencing clinical laboratory AEs
Measured: Day 1 through Day 61
Percentage of participants experiencing clinical laboratory AEs
Percentage of participants experiencing clinical laboratory AEs
Measured: Day 1 through Day 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start13 Jan 2025
- Primary completion11 May 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lassa FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase 1, randomized, controlled, recipient- and observer-blinded, dose-escalation clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilbur Chen, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wilbur Chen, MD, MS, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546709
- Sponsor's protocol ID
- DMID 23-0015
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ortiz JR, Kurup D, Kaufman AC, Ben Hamed S, LaRocco AM, Lyke KE, Litts SM, Datta S, Liang Y, McGilvray MF, Losignor JA, Oshinsky JJ, Palmer KV, Johnson-Mayo IP, Scher G, Balakumar U, Chandwani A, Rapaka RR, Deming ME, Chua JV, Wirblich C, Chen WH, Neuzil KM, Pasetti MF, Schnell MJ. Adjuvanted inactivated rabies virus-vectored Lassa virus vaccine in healthy adults: a phase 1 trial. Nat Med. 2026 Jul;32(7):2511-2521. doi: 10.1038/s41591-026-04429-z. Epub 2026 Jun 9.
PubMed 42265408
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06546709
- Acronym / sponsor ID
- DMID 23-0015
- Conditions
- Lassa Fever
- Keywords
- Lassa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wilbur Chen, MD, MSUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 300,000 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 5,000 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- This is a phase 1, randomized, controlled, recipient- and observer-blinded, dose-escalation clinical trial
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - LASSARAB+ aPHAD-SE Vaccine at 700rU or Active Comparator (AC) | Experimental | Biological: LASSARAB+ aPHAD-SEat 700rU, Biological: HDCV Comparator4:1 randomization to investigational vaccine or active comparator (n=5) |
| Cohort 2 - LASSARAB+ aPHAD-SE Vaccine at 700rU or 1400rU or AC | Experimental | Biological: LASSARAB+ aPHAD-SEat 700rU, Biological: HDCV Comparator, Biological: LASSARAB+ aPHAD-SEat 1400rU11:4:3 randomization to investigational vaccine dose 700rU or 1400rU or active comparator (n=18) |
| Cohort 3 - LASSARAB+ aPHAD-SE Vaccine at 1400rU Single or Double or AC or AC/Placebo | Experimental | Biological: HDCV Comparator, Other: Normal Saline Placebo, Biological: LASSARAB+ aPHAD-SEat 1400rU11:2:4:1 randomization to investigational vaccine single dose at 1400rU or investigational vaccine (2 doses) at 14rU or active comparator or active comparator and normal saline placebo |
| Cohort 4 - LASSARAB+ aPHAD-SE Vaccine at 1400rU (single) or AC/Placebo | Experimental | Biological: HDCV Comparator, Other: Normal Saline Placebo, Biological: LASSARAB+ aPHAD-SEat 1400rU11:3 randomization to investigational vaccine (2 doses) at 14rU or active comparator and normal saline placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
- In good general health and without clinically significant medical, psychiatric, chronic or intermittent health conditions including those listed in 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.
Key exclusion criteria (15 listed)
- 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
- Current use of any medications that may be associated with impaired immune responsiveness
- Allergy treatment with antigen injections within 60 days before first vaccination or that are planned through the end of the study.
- 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.
- Current pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASSARAB+ aPHAD-SEat 700rURabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) with 3D-(6- acyl) Phosphorylated Hexaacyl Disaccharides (PHAD)-Stable squalene oil-in-water nanoemulsion (aPHAD-SE) adjuvant administered by IM injection | Biological | Cohort 1 - LASSARAB+ aPHAD-SE Vaccine at 700rU or Active Comparator (AC), Cohort 2 - LASSARAB+ aPHAD-SE Vaccine at 700rU or 1400rU or AC |
| HDCV ComparatorAlso: ImovaxSterile, stable, freeze-dried suspension of rabies virus prepared from strain PM-1503-3M | Biological | Cohort 1 - LASSARAB+ aPHAD-SE Vaccine at 700rU or Active Comparator (AC), Cohort 2 - LASSARAB+ aPHAD-SE Vaccine at 700rU or 1400rU or AC, Cohort 3 - LASSARAB+ aPHAD-SE Vaccine at 1400rU Single or Double or AC or AC/Placebo, Cohort 4 - LASSARAB+ aPHAD-SE Vaccine at 1400rU (single) or AC/Placebo |
| Normal Saline PlaceboSterile 0.9% sodium chloride for injection, USP, or normal saline, is a sterile, nonpyrogenic, isotonic solution; each mL contains sodium chloride 9 mg | Other | Cohort 3 - LASSARAB+ aPHAD-SE Vaccine at 1400rU Single or Double or AC or AC/Placebo, Cohort 4 - LASSARAB+ aPHAD-SE Vaccine at 1400rU (single) or AC/Placebo |
| LASSARAB+ aPHAD-SEat 1400rURabies-Vectored Monovalent Lassa Fever Vaccine (LASSARAB) with 3D-(6- acyl) Phosphorylated Hexaacyl Disaccharides (PHAD)-Stable squalene oil-in-water nanoemulsion (aPHAD-SE) adjuvant administered by IM injection | Biological | Cohort 2 - LASSARAB+ aPHAD-SE Vaccine at 700rU or 1400rU or AC, Cohort 3 - LASSARAB+ aPHAD-SE Vaccine at 1400rU Single or Double or AC or AC/Placebo, Cohort 4 - LASSARAB+ aPHAD-SE Vaccine at 1400rU (single) or AC/Placebo |
Primary outcome
Number of participants experiencing solicited local and systemic events
Time frame: 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 solicited local and systemic reactogenicity Adverse Events (AEs)
Percentage of participants experiencing solicited local and systemic events
Time frame: 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 reactogenicity Adverse Events (AEs)
Number of participants experiencing unsolicited events
Time frame: Day 1 through Day 61
Number of participants experiencing any unsolicited AEs
Percentage of participants experiencing unsolicited events
Time frame: Day 1 through Day 61
Percentage of participants experiencing any unsolicited AEs
Number of participants experiencing Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 394
Number of participants experiencing SAEs
Percentage of participants experiencing Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 394
Percentage of participants experiencing SAEs
Number of participants experiencing Medically-Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 394
Number of participants experiencing MAAEs
Percentage of participants experiencing Medically-Attended Adverse Events (MAAEs)
Time frame: Day 1 through Day 394
Percentage of participants experiencing MAAEs
Number of participants experiencing New-Onset Chronic Medical Conditions (NOCMCs)
Time frame: Day 1 through Day 394
Number of participants experiencing NOCMCs
Percentage of participants experiencing New-Onset Chronic Medical Conditions (NOCMCs)
Time frame: Day 1 through Day 394
Percentage of participants experiencing NOCMCs
Number of participants experiencing Potential Immune-Mediated Medical Conditions (PIMMCs)
Time frame: Day 1 through Day 394
Number of participants experiencing PIMMCs
Percentage of participants experiencing Potential Immune-Mediated Medical Conditions (PIMMCs)
Time frame: Day 1 through Day 394
Percentage of participants experiencing PIMMCs
Number of participants experiencing Adverse Event of Special Interest (AESI)
Time frame: Day 1 through Day 394
Number of participants experiencing Adverse Event of Special Interest (AESI) - new onset sensorineural hearing loss (SNHL)
Percentage of participants experiencing Adverse Event of Special Interest (AESI)
Time frame: Day 1 through Day 394
Percentage of participants experiencing Adverse Event of Special Interest (AESI) - new onset sensorineural hearing loss (SNHL)
Number of participants experiencing clinical laboratory AEs
Time frame: Day 1 through Day 61
Number of participants experiencing clinical laboratory AEs
Percentage of participants experiencing clinical laboratory AEs
Time frame: Day 1 through Day 61
Percentage of participants experiencing clinical laboratory AEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 42265408Ortiz JR, Kurup D, Kaufman AC, Ben Hamed S, LaRocco AM, Lyke KE, Litts SM, Datta S, Liang Y, McGilvray MF, Losignor JA, Oshinsky JJ, Palmer KV, Johnson-Mayo IP, Scher G, Balakumar U, Chandwani A, Rapaka RR, Deming ME, Chua JV, Wirblich C, Chen WH, Neuzil KM, Pasetti MF, Schnell MJ. Adjuvanted inactivated rabies virus-vectored Lassa virus vaccine in healthy adults: a phase 1 trial. Nat Med. 2026 Jul;32(7):2511-2521. doi: 10.1038/s41591-026-04429-z. Epub 2026 Jun 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LASSARAB+ aPHAD-SEat 700rU, HDCV Comparator and LASSARAB+ aPHAD-SEat 1400rU in people with Lassa Fever, run by Wilbur Chen, MD, MS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing solicited local and systemic events (time frame: From Day 1 through Day 8 for the first vaccination and from Day 29 through Day 36 for the second vaccination, as applicable). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546709, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.