drugset / Trial / NCT02603055
A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults
Phase 1
Completed
60 enrolled
Jiangsu Province Centers for Disease Control and Prevention
Changchun Institute of Biological Products Co., Ltd. · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine. This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.
Timeline
- Start
- 2015-07
- Primary completion
- 2016-04
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hecolin® | Vaccine | 30 ug | — |
| Comparator | Recombinant Hepatitis E vaccine | Vaccine | 30 ug | — |