← Back to all trials
Completed
NCT06546709
DMID 23-0015; Lassa Fever CVD 1000
Conditions: Lassa Fever
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 54
Sponsor: Wilbur Chen, MD, MS
Location: University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health Baltimore Maryland
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT06546709). StuddyBuddy aggregates publicly available trial information.
