Phase 1
N=67
Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01765426 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff — 16.7; 11.8; 11.8; 13.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- TDV (Biological); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff |
16.7; 11.8; 11.8; 13.3; 83.3; 88.2 | — |
| PRIMARY Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity |
83.3; 76.5; 88.2; 80.0; 22.2; 35.3 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity |
94.4; 100.0; 88.2; 100.0; 5.6; 0 | — |
| PRIMARY Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity |
50.0; 41.2; 35.3; 40.0; 50.0; 58.8 | — |
| PRIMARY Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity |
16.7; 17.6; 52.9; 33.3; 11.1; 11.8 | — |
| PRIMARY Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) |
5.6; 0; 0; 0; 5.6; 0 | — |
| PRIMARY Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection |
75.0; 38.5; 62.5; 84.6; 62.5; 61.5 | — |
| PRIMARY Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection |
75.0; 69.2; 87.5; 84.6; 68.8; 69.2 | — |
| PRIMARY Percentage of Participants With Unsolicited Vaccine-Related SAEs |
0; 0; 0; 0 | — |
| SECONDARY Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes |
5.0; 5.0; 5.0; 5.0; 5.0; 5.0 | — |
| SECONDARY Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 |
68.8; 61.5; 62.5; 76.9; 75.0; 69.2 | — |
| SECONDARY Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination |
0; 0; 0; 0; 38.9; 23.5 | — |
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).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01765426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.