drugset / Trial / NCT03776994
Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine
Phase 1
Unknown
48 enrolled
SRI International
US Army Medical Research Institute of Infectious Diseases · collab
RandomizedSequentialSingle-blindPrevention
Summary
The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection at escalating doses of 2 μg, 10 μg, and 20 μg as a 2-dose primary series (Day 0, Day 28) with a Day 140 booster dose. The secondary objective of the study is to evaluate immunogenicity of the vaccine at the aforementioned time points
Timeline
- Start
- 2018-07-17
- Primary completion
- 2020-07-27
- Completion
- 2021-04
Publications
- Background Hoke CH Jr. History of U.S. military contributions to the study of viral encephalitis. Mil Med. 2005 Apr;170(4 Suppl):92-105. doi: 10.7205/milmed.170.4s.92.
- Background Tyler KL. Acute Viral Encephalitis. N Engl J Med. 2018 Aug 9;379(6):557-566. doi: 10.1056/NEJMra1708714. No abstract available.
- Background Paessler S, Weaver SC. Vaccines for Venezuelan equine encephalitis. Vaccine. 2009 Nov 5;27 Suppl 4:D80-5. doi: 10.1016/j.vaccine.2009.07.095.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VEE VLP Vaccine | Vaccine | 2 ug | Intramuscular |
| Subject | VEE VLP Vaccine | Vaccine | 10 ug | Intramuscular |
| Subject | VEE VLP Vaccine | Vaccine | 20 ug | Intramuscular |
| Background | Aluminum hydroxide | Unknown | 5 mg/ml | — |