drugset / Trial / NCT02657161
Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Phase 1
Completed
37 enrolled
Yisheng Biopharma (Singapore) Pte. Ltd.
Duke-NUS Graduate Medical School · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Phase I clinical study for an investigational PIKA (Polyinosinic-Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. The primary objective of the study was to assess the clinical safety of the vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the vaccine's efficacy based on an accelerated vaccine regimen.
Timeline
- Start
- 2015-02
- Primary completion
- 2015-07
- Completion
- 2015-07
Publications
- Yu P, Liu Y, Tao X, He Y, Liu Q, Wang B, Zheng H, Zhang N, Bi S, Zhu W, Zhang Y. Potential option for rabies post-exposure prophylaxis: New vaccine with PIKA adjuvant against diverse Chinese rabies strains. Vaccine. 2023 Nov 2;41(46):6852-6862. doi: 10.1016/j.vaccine.2023.10.001. Epub 2023 Oct 9.
- Wijaya L, Tham CYL, Chan YFZ, Wong AWL, Li LT, Wang LF, Bertoletti A, Low JG. An accelerated rabies vaccine schedule based on toll-like receptor 3 (TLR3) agonist PIKA adjuvant augments rabies virus specific antibody and T cell response in healthy adult volunteers. Vaccine. 2017 Feb 22;35(8):1175-1183. doi: 10.1016/j.vaccine.2016.12.031. Epub 2017 Jan 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PIKA rabies vaccine | Vaccine | 1 ml | Intramuscular |
| Comparator | Rabies vaccine | Vaccine | 1 ml | Intramuscular |