Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults

NCT03771963 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: DEN-307U1111-1222-2812
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.

Conditions

Dengue Fever

Keywords

Live Attenuated Tetravalent Dengue Vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120

  GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4.

  One month post second dose (Day 120)

Secondary Outcomes (8)

• Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270

  One month and six months post second dose (Days 120 and 270)

• Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270

  One month and six months post second dose (Days 120 and 270)

• Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270

  Six months post second dose (Day 270)

• Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity

  Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccination

• Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity

  Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination

Study Arms (1)

Tetravalent Dengue Vaccine (TDV)

EXPERIMENTAL

TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose).

Biological: Tetravalent Dengue Vaccine (TDV)

Interventions

Tetravalent Dengue Vaccine (TDV) BIOLOGICAL

TDV SC injection.

Tetravalent Dengue Vaccine (TDV)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Participants who sign and date 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.

You may not qualify if:

• Participants with a clinically significant active infection (as assessed by the investigator) or body temperature ≥38°C (≥100.4°F) within 3 days of the intended date of vaccine administration
• Known or suspected impairment/alteration of immune function, including:
• Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks and/or ≥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 and/or ≥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).
• Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
• Hepatitis C virus infection.
• Genetic immunodeficiency.
• With Body Mass Index (BMI) greater than or equal to 35 kg/m\^2(=weight in kg/height in meters\^2).
• Participants who have known hypersensitivity or allergy to any of the vaccine components.
• Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue, Yellow Fever (YF), Japanese Encephalitis (JE) viruses or tick-borne encephalitis.
• Previous participation in any clinical trial of a dengue or other flavivirus (e.g., West Nile \[WN\] virus) candidate vaccine, except for participants who received placebo in those trials.
• With a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92805, United States

Location

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

Location

Related Publications (2)

• Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.

  PMID: 40099800 DERIVED

• Patel SS, Winkle P, Faccin A, Nordio F, LeFevre I, Tsoukas CG. An open-label, Phase 3 trial of TAK-003, a live attenuated dengue tetravalent vaccine, in healthy US adults: immunogenicity and safety when administered during the second half of a 24-month shelf-life. Hum Vaccin Immunother. 2023 Aug;19(2):2254964. doi: 10.1080/21645515.2023.2254964. Epub 2023 Oct 17.

  PMID: 37846724 DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Dengue Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  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: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: March 28, 2019
• Primary Completion: October 14, 2019
• Study Completion: March 13, 2020
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (2)