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

NCT ID: NCT01765426

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-15
• Study Completion Date: 2014-06-26

Brief 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).

Detailed 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group 1: TDV using PharmaJet® Injector

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.

Group Type: EXPERIMENTAL

TDV

Intervention Type: BIOLOGICAL

TDV suspension for intradermal administration

Placebo

Intervention Type: DRUG

Phosphate buffered saline (PBS)

Group 2: TDV using PharmaJet® Injector

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.

Group Type: EXPERIMENTAL

TDV

Intervention Type: BIOLOGICAL

TDV suspension for intradermal administration

Placebo

Intervention Type: DRUG

Phosphate buffered saline (PBS)

Group 3: TDV using Needle and Syringe

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.

Group Type: EXPERIMENTAL

TDV

Intervention Type: BIOLOGICAL

TDV suspension for intradermal administration

Placebo

Intervention Type: DRUG

Phosphate buffered saline (PBS)

Group 4: TDV using PharmaJet® Injector

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.

Group Type: EXPERIMENTAL

TDV

Intervention Type: BIOLOGICAL

TDV suspension for intradermal administration

Interventions

TDV

TDV suspension for intradermal administration

Intervention Type: BIOLOGICAL

Placebo

Phosphate buffered saline (PBS)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Group Health Research Institute

Seattle, Washington, United States

Countries

United States

References

Jackson LA, Rupp R, Papadimitriou A, Wallace D, Raanan M, Moss KJ. A phase 1 study of safety and immunogenicity following intradermal administration of a tetravalent dengue vaccine candidate. Vaccine. 2018 Jun 22;36(27):3976-3983. doi: 10.1016/j.vaccine.2018.05.028. Epub 2018 May 19.

Reference Type: DERIVED

PMID: 29789238 (View on PubMed)

Other Identifiers

U1111-1178-6503

Identifier Type: REGISTRY

Identifier Source: secondary_id

11-0049

Identifier Type: -

Identifier Source: org_study_id