Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector

• Status: Completed
• Trial end date: 2014-06-26
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Collaborator: National Institutes of Health (NIH)

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.