Lassa Fever
Conditions
Interventions
rVSVn4g LASVgpc1 EBS LASV
Sponsors
Emergent Product Development Gaithersburg Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject understands the study as outlined in the informed consent form (ICF) and its procedures, agrees to study-related assessments, study visits, and voluntarily provides informed consent by signing the ICF. 2. Age: 18 to 50 years (inclusively). 3. Body mass index (BMI) of 18 to 30 kg/m2 at Screening Visit. 4. Hearing threshold between -10 to 15 decibels (dB) across low, middle, and high frequencies as measured by audiometry. 5. Generally healthy, in the opinion of the Investigator, based on medical history, physical examination and screening laboratory assessments. 6. Women who are EITHER: i. Not of childbearing potential (CBP): anatomically sterile, or post-menopausal (defined as elevated FSH and =12 months without menses). OR: ii. Meet all the below criteria: • Negative serum pregnancy test at Screening Visit. • Negative urine pregnancy test immediately prior to dosing at Day 1. • Do not intend to become pregnant during the study. • Using one of these medically acceptable methods of contraception (if woman of CBP) for the duration of participation, such as: • Hormonal contraceptives (e.g., implants, pills, patches [combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine hormone-releasing system]) initiated =30 days prior to dosing. • Intrauterine device (IUD) inserted =30 days prior to dosing. • Bilateral tubal ligation.
Exclusion criteria
Exclusion criteria: 1. Currently pregnant or lactating. 2. Laboratory evidence of infection with human immunodeficiency virus (HIV), hepatitis B or C viruses (HBV or HCV). 3. History of cardiac disease. 4. History of severe allergic reaction or anaphylaxis. 5. History of any immunodeficiency or immunocompromising condition that could impact response to IP administration. 6. Receipt or anticipated receipt of blood products from 180 days prior to screening to 30 days post IP administration. 7. Current or past participation in a study with an IP from 30 days prior to screening through study duration. 8. Receipt or anticipated receipt of any vaccines or systemic immunomodulatory agents from 30 days prior to screening to 90 days post IP administration. 9. Evidence of current or past (over the past 5 years) use or treatment for alcohol or drug abuse. 10. Planned medical procedure during the study. 11. Medical condition that, in the opinion of the Investigator, could adversely impact the subject. 12. Chronic or acute severe neurologic condition 13. Clinically significant medical condition or laboratory assessment. 14. Abnormal clinically significant electrocardiogram (ECG) at screening. 15. Acute condition not resolved at least 14 days prior to IP dosing. 16. History of LASV infection/disease. 17. Prior residence greater than 30 days in a LASV-endemic region. 18. Prior receipt of any investigational LASV vaccine. 19. Prior receipt of a VSV-vectored Ebola virus vaccine. 20. Prior known infection with VSV. 21. History of hearing loss.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs;Incidence of serious adverse events /SAEs ;Incidence of adverse event of special interest /AESI/;Incidence of rVSV viral shedding in blood, urine, and saliva ;Incidence of reactogenicity events /solicited systemic and injection site reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| LASV neutralizing antibody /nAb/ levels ;LASV-GP-specific immunoglobulin G /IgG/ levels | — |
Countries
Ghana
Contacts
Public ContactHugo Astacio
Snr Manager Product Safety Physicia
Outcome results
None listed