Phase
Condition
Fever
Treatment
LASSARAB+ aPHAD-SEat 700rU
Normal Saline Placebo
HDCV Comparator
Clinical Study ID
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 beavailable 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 ExclusionCriteria
Participants of childbearing potential must have a negative serum human chronicgonadotropin (HCG) pregnancy test at screening and a negative urine HCG pregnancytest within 24 hours prior to the study vaccination.
Participants of childbearing potential in a heterosexual relationship agree to useof highly effective contraception beginning at the time of the screening visitthrough Day 61 (32 days after the last study treatment).
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 Cvirus (HCV) antibody6, and human immunodeficiency virus (HIV) types 1 or 2antibodies at screening.
Has a negative rabies neutralization test at screening (< 0.1 IU/mL in RFFIT assay)
Screening hematology tests (white blood cells, hemoglobin, and platelets) andscreening chemistry tests (alanine transaminase, creatine, and total bilirubin) arewithin acceptable parameters
Must agree to the collection and storage of residual biological specimens andadditional clinical specimens for secondary research use
Agreement to adhere to Lifestyle Considerations during the study
Exclusion
Exclusion Criteria:
A history of anaphylaxis, serum sickness, meningitis; neuroparalytic events such asencephalitis, transient paralysis; Guillain-Barré Syndrome; myelitis; retrobulbarneuritis; history of prior or current hearing loss as assessed by quantitativeaudiometry; or multiple sclerosis
Current use of any medications that may be associated with impaired immuneresponsiveness
Allergy treatment with antigen injections within 60 days before first vaccination orthat are planned through the end of the study.
Receipt of immunoglobulins and/or any blood products within the 60 days before firstvaccination 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 (humanalbumin, neomycin sulfate, phenol red, beta-propiolactone); 3) any components ofLASSARAB +aPHAD-SE (LASSARAB, Tris-HCI, L-Arginine, (3D -(6-Acyl) PHAD, SqualeneRedistilled, DMPC, Vitamin E Dry Powder).
History of severe local or systemic reactions to any vaccination or a history ofsevere allergic reactions to drug or vaccine products.
Has a significant acute illness (with or without fever), as determined by the sitePI or appropriate sub-investigator, within 72 hours prior to enrollment
Receipt of a rabies vaccine or an antibody therapeutic product for treating rabiesor a Lassa fever vaccine any time before the first planned study vaccination.
Receipt of another experimental agent or intervention within 60 days before firstvaccination 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 firstvaccination through Day 61 (32 days after the last study treatment).
Received or plans to receive any live vaccine in the 4 weeks prior to firstvaccination 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 participationbecause 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.
Study Design
Study Description
Connect with a study center
University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland 21201
United StatesActive - Recruiting
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