Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
Key facts
- Study ID
- NCT01765426
- Run by
- Takeda
- People needed
- 67
- Starts
- 2013-02-15
- Expected to finish
- 2014-06-26
- Last updated by the study team
- 2019-07-18
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- In good health as determined by medical history and physical examination (including blood pressure and heart rate).
- Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies \& Hepatitis B surface antigen.
- Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
- Body Mass Index (BMI) ≤ 35 kg/m\^2.
You may not qualify if…
- Any Grade 2 or above abnormality in the screening laboratory tests.
- History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.
- Seropositivity to dengue or West Nile virus.
- Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.
- History of significant dermatologic disease in the last 6 months.
- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 vaccinations.
- Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening.
- Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month prior to the first vaccination.
- Use of any prescribed medication 7 days before the first injection.
- Previous vaccination in a clinical study or with an approved product against Dengue Fever, Yellow Fever and or Japanese Encephalitis.
- Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy in the last 6 months.
- Planned donation of blood during the period of the study.
Where it is running
- University of Texas Medical Branch — Galveston, Texas, United States
- Group Health Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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