NCT03525119

Brief Summary

The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous \[SC\] injection) and of hepatitis A virus (HAV) vaccine (intramuscular \[IM\] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P50-P75 for phase_3 healthy-volunteers

Timeline
Completed

Started May 2018

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

May 16, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 13, 2020

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

April 27, 2018

Results QC Date

June 24, 2020

Last Update Submit

August 17, 2022

Conditions

Healthy Volunteers

Keywords

Vaccine

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants HAV/Dengue Virus (DENV)-Naive at Baseline Who Are Seroprotected Against HAV at Day 30

    Seroprotection is defined as serum anti-HAV antibody levels ≥12.5 mIU/mL, measured by enzyme-linked immunosorbent assay (ELISA). Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels \<12.5 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes \<10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.

    One month post first vaccination (Day 30)

Secondary Outcomes (8)

  • Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 30 and Day 120 in Participants HAV/DENV-naive at Baseline

    One month post first vaccination (Day 30) and one month post second vaccination (Day 120)

  • Percentage of Participants HAV/DENV-naive at Baseline Who Are Seropositive for Each of the 4 Dengue Serotypes at Day 30 and Day 120

    One month post first vaccination (Day 30) and one month post second vaccination (Day 120)

  • Geometric Mean Concentrations (GMC) of Anti-HAV Antibodies at Day 30 in Participants HAV/DENV-naive at Baseline

    One month post first vaccination (Day 30)

  • Percentage of Participants With Solicited (Local Injection) Site Adverse Events (AEs) by Severity After Each Vaccination

    Within 7 days after each vaccination

  • Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination

    Within 14 days after each vaccination

  • +3 more secondary outcomes

Study Arms (3)

HAV Vaccine 1.0 ml + Placebo/ Placebo

OTHER

HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose).

Biological: HAV VaccineBiological: TDV Placebo

TDV 0.5 ml + Placebo/ TDV 0.5 ml

EXPERIMENTAL

TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).

Biological: TDVBiological: HAV Vaccine Placebo

TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml

EXPERIMENTAL

TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose).

Biological: TDVBiological: HAV Vaccine

Interventions

TDVBIOLOGICAL

TDV SC injection

TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 mlTDV 0.5 ml + Placebo/ TDV 0.5 ml
HAV VaccineBIOLOGICAL

HAV Vaccine IM injection.

HAV Vaccine 1.0 ml + Placebo/ PlaceboTDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml
TDV PlaceboBIOLOGICAL

Placebo-matching (normal saline (0.9% NaCl) SC injection.

HAV Vaccine 1.0 ml + Placebo/ Placebo
HAV Vaccine PlaceboBIOLOGICAL

Placebo-matching (normal saline (0.9% NaCl) IM injection.

TDV 0.5 ml + Placebo/ TDV 0.5 ml

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant is aged 18 to 60 years, inclusive.
  • Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
  • The participant signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
  • Participants who can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if:

  • Participants with an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
  • Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccines or placebo).
  • Participants with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
  • Participants with any history of progressive or severe neurologic disorder, seizure disorder orneuro-inflammatory disease (eg, Guillain-Barré syndrome).
  • Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participant due to participation in the trial.
  • Known or suspected impairment/alteration of immune function, including:
  • Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
  • Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0).
  • Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
  • Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
  • Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
  • Human immunodeficiency virus (HIV) infection or HIV-related disease.
  • Hepatitis A virus (HAV) infection.
  • Hepatitis C virus infection.
  • Genetic immunodeficiency.
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Synexus - Midlands

Edgbaston, Birmingham, B15 2SQ, United Kingdom

Location

Synexus - Lancashire

Chorley, Lancashire, PR7 7NA, United Kingdom

Location

Synexus - Merseyside

Waterloo, Liverpool, L22 0LG, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, Yorkshire, S10 2JF, United Kingdom

Location

Synexus - Wales

Cardiff, CF15 9SS, United Kingdom

Location

Synexus - Scotland

Glasgow, G20 0SP, United Kingdom

Location

North East Clinical Research Centre, Hexham General Hospital

Hexham, NE46 1QJ, United Kingdom

Location

Synexus - Manchester

Manchester, M15 6SX, United Kingdom

Location

Synexus - Thames Valley

Reading, RG2 0TG, United Kingdom

Location

North Tees Clinical Research Centre, Middlefield Centre, University Hospital of North Tees

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Related Publications (1)

  • Tricou V, Eyre S, Ramjee M, Collini P, Mojares Z, Loeliger E, Mandaric S, Rauscher M, Brose M, Lefevre I, Folschweiller N, Wallace D. A randomized phase 3 trial of the immunogenicity and safety of coadministration of a live-attenuated tetravalent dengue vaccine (TAK-003) and an inactivated hepatitis a (HAV) virus vaccine in a dengue non-endemic country. Vaccine. 2023 Feb 10;41(7):1398-1407. doi: 10.1016/j.vaccine.2023.01.007. Epub 2023 Jan 19.

    PMID: 36681529DERIVED

Related Links

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 15, 2018

Study Start

May 16, 2018

Primary Completion

October 3, 2018

Study Completion

July 9, 2019

Last Updated

August 19, 2022

Results First Posted

July 13, 2020

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Locations

GB(10)