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

Takeda

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Biological: TDV

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01765426

11-0049

U1111-1178-6503 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.

Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).

Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.

Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).

This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.

Enrollment: 67 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 4 patient groups

Group 1: TDV using PharmaJet® Injector

Experimental group

Description:

Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.

Treatment:

Biological: TDV

Drug: Placebo

Group 2: TDV using PharmaJet® Injector

Experimental group

Description:

TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.

Treatment:

Biological: TDV

Drug: Placebo

Group 3: TDV using Needle and Syringe

Experimental group

Description:

TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.

Treatment:

Biological: TDV

Drug: Placebo

Group 4: TDV using PharmaJet® Injector

Experimental group

Description:

TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.

Treatment:

Biological: TDV