Clinical trial NCT03771963: Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Official title: An Open-Label, Phase 3 Trial to Investigate the Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) at the End of Shelf Life in Healthy Adults in Non-Endemic Country(Ies) for Dengue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dengue Fever
Keywords: Live Attenuated Tetravalent Dengue Vaccine
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: The vaccine being tested in this study is tetravalent dengue vaccine (TDV). The primary objective of this study is to evaluate the immune response and safety of a naturally aged (\>12 months stored at 2°C to 8°C) lot of TDV in a healthy adult population in country(ies) non-endemic for dengue. The assessment of a naturally aged lot of TDV in this clinical trial will provide an important contribution to data on TDV stability throughout the shelf life of the product.

The study will enroll approximately 200 participants. Participants will be enrolled to the one treatment group:

Tetravalent Dengue Vaccine (TDV)

All participants will receive subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3).

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 9 months. Participants will make multiple visits to the clinic including a final visit at Day 270 (Month 9).

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1. 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
2. Known or suspected impairment/alteration of immune function, including:

   1. 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).
   2. 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).
   3. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
   4. Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
   5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
   6. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
   7. Hepatitis C virus infection.
   8. Genetic immunodeficiency.
3. With Body Mass Index (BMI) greater than or equal to 35 kg/m\^2(=weight in kg/height in meters\^2).
4. Participants who have known hypersensitivity or allergy to any of the vaccine components.
5. Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue, Yellow Fever (YF), Japanese Encephalitis (JE) viruses or tick-borne encephalitis.
6. 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.
7. 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.
8. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
9. Participants with history of substance or alcohol abuse within the past 2 years.
10. Participants who have any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

Primary outcomes:
measure: Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
timeFrame: One month post second dose (Day 120)
Secondary outcomes:
measure: Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270
timeFrame: One month and six months post second dose (Days 120 and 270)
measure: Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270
timeFrame: One month and six months post second dose (Days 120 and 270)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
timeFrame: Six months post second dose (Day 270)
measure: Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by Severity
timeFrame: Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccination
measure: Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by Severity
timeFrame: Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination
measure: Percentage of Participants With Any Unsolicited Adverse Events Following Each Vaccination
timeFrame: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days)
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: From first vaccination (Day 1) through end of study (Day 270)
measure: Percentage of Participants With Medically Attended Adverse Events (MAAEs)
timeFrame: From first vaccination (Day 1) through end of study (Day 270)
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Hutchinson
country: United States
facility: Hutchinson Clinic
state: Kansas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: