What is the mechanism of action of this treatment?

The Tetravalent Dengue Vaccine (TDV) Booster Dose works by stimulating the immune system to produce antibodies against all four dengue serotypes, providing broad protection against the virus. This is crucial for Dengue Fever patients as it helps prevent severe disease and complications associated with infection by different serotypes. Other common treatments for Dengue Fever primarily focus on supportive care, such as fluid replacement to manage dehydration and pain relievers to reduce fever and discomfort. These treatments are essential to maintain patient stability and prevent severe outcomes like dengue hemorrhagic fever or dengue shock syndrome.

What side effects are associated with this type of intervention?

The most common side effects of the Tetravalent Dengue Vaccine (TDV) Booster Dose include local reactions at the injection site, such as pain, redness, and swelling. Systemic reactions may include fever, headache, and malaise. In clinical trials, these side effects were generally mild and transient. Serious adverse events were rare but included hypersensitivity reactions. Long-term follow-up studies indicated that the vaccine was well-tolerated with no significant increase in adverse events over time.

What prior FDA approvals exist?

As of now, there are no FDA-approved vaccines specifically for the prevention of Dengue Fever that function similarly to the Tetravalent Dengue Vaccine (TDV) Booster Dose, which aims to stimulate the immune system to produce antibodies against all four dengue serotypes. The development of such vaccines is ongoing, and the TDV booster dose is part of these efforts to provide comprehensive protection against the disease.

What other types of research exist?

Promising novel alternatives to the Tetravalent Dengue Vaccine (TDV) booster dose for dengue fever patients include: 1) Recombinant adenovirus vector vaccines encoding dengue viral proteins, which are currently leading candidates in vaccine trials. 2) Antiviral drugs such as Favipiravir, which has shown efficacy in small animal models and is being evaluated for human use. 3) Monoclonal antibodies targeting dengue virus, which have demonstrated potential in preventing and treating dengue infections in clinical studies.

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Virus Vaccine

Dengue Vaccine for Dengue Fever

Phase 3

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose

Awards & highlights

Summary

This trial studies how long immunity lasts and the effect of a booster dose of a dengue vaccine in healthy adolescents and adults who participated in previous studies. The vaccine uses weakened viruses to help the body build defenses against dengue fever. It has shown strong initial protection but there are concerns about long-term immunity and safety.

Who is the study for?

This trial is for men and women who participated in previous dengue vaccine trials (DEN-304 or DEN-315) and received at least one dose of Takeda's TDV. They must have had a blood test after vaccination. People living in dengue areas for over a year recently, or vaccinated against related viruses like yellow fever, can't join.

What is being tested?

The study tests the long-term safety of Takeda's Dengue Vaccine (TDV) and how well it keeps working up to 63 months after first getting it. It also looks at whether a booster shot increases protection against all four types of dengue virus compared to a placebo.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to the TDV vaccine or booster dose as part of assessing its long-term safety.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)

GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 43 (Mexico)

GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 21 (US)

+21 more

Secondary study objectives

GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Post-booster Dose

Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for all Participants Prior to the Booster Dose

Percentage of Participants with Solicited Local Injection Site Adverse Events (AEs) by Severity, Post-booster Dose

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)Experimental Treatment1 Intervention

TDV 0.5 mL, injection, subcutaneously, once at Month 15 for participants from parent trials DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).

Group II: PlaceboPlacebo Group1 Intervention

TDV placebo-matching 0.5 mL injection, subcutaneously, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Tetravalent Dengue Vaccine (TDV) Booster Dose works by stimulating the immune system to produce antibodies against all four dengue serotypes, providing broad protection against the virus. This is crucial for Dengue Fever patients as it helps prevent severe disease and complications associated with infection by different serotypes. Other common treatments for Dengue Fever primarily focus on supportive care, such as fluid replacement to manage dehydration and pain relievers to reduce fever and discomfort. These treatments are essential to maintain patient stability and prevent severe outcomes like dengue hemorrhagic fever or dengue shock syndrome.

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Who is running the clinical trial?

TakedaLead Sponsor

1,227 Previous Clinical Trials

4,222,140 Total Patients Enrolled

10 Trials studying Dengue Fever

15,800 Patients Enrolled for Dengue Fever

Study DirectorStudy DirectorTakeda

1,252 Previous Clinical Trials

504,014 Total Patients Enrolled

3 Trials studying Dengue Fever

11,000 Patients Enrolled for Dengue Fever

Medical DirectorStudy DirectorTakeda

2,834 Previous Clinical Trials

8,079,415 Total Patients Enrolled

22 Trials studying Dengue Fever

73,199 Patients Enrolled for Dengue Fever

Media Library

Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03999996 — Phase 3

Dengue Fever Research Study Groups: Placebo, Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)

Dengue Fever Clinical Trial 2023: Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Highlights & Side Effects. Trial Name: NCT03999996 — Phase 3

Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999996 — Phase 3

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