Several clinical trials investigate conditions including tick-borne encephalitis, tick bites, tick fever, generalized tick-borne diseases, and Japanese encephalitis vaccination protocols using Phase 4 interventional and observational study designs. Sponsored by regional healthcare organizations like Region Örebro County, academic medical centers such as Strasbourg University Hospital, Oslo University Hospital, and the Medical University of Vienna, and industry partners including Valneva Austria GmbH, these protocols encompass actively recruiting, not yet recruiting, and unknown recruitment statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04573205 | Not yet recruiting | Tick-borne Encephalitis|Vaccine |
Region Örebro County |
2024-01 | Phase 4 |
| NCT05607394 | Recruiting | Tick-borne Encephalitis |
University Hospital Strasbourg France |
2022-10-24 | -- |
| NCT05138055 | Recruiting | Tick-Borne Encephalitis European |
Sykehuset Telemark|Sykehuset i Vestfold HF|Norwegian Institute of Public Health|Sorlandet Hospital HF|Oslo University Hospital |
2020-10-01 | -- |
| NCT03932448 | Unknown status | Tick-Bite; Fever|Tick Fever|Tick-Borne Diseases|Encephalitis Tick-Borne|Tick Bites |
Göteborg University|Sahlgrenska University Hospital Sweden|Vastra Gotaland Region |
2019-05-15 | -- |
| NCT03971058 | Unknown status | Japanese Encephalitis Vaccine |
Medical University of Vienna|Valneva Austria GmbH |
2019-03-01 | Phase 4 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
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