A study to assess a new Lassa Virus Vaccine in healthy volunteers
- Conditions
- Lassa Fever
- Registration Number
- PACTR202108781239363
- Lead Sponsor
- Emergent Product Development Gaithersburg Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 108
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method