Qdenga (dengue tetravalent vaccine [live, attenuated]) / Takeda - LARVOL DELTA

Efficacy, public health impact and optimal use of the Takeda dengue vaccine. (PubMed, Nat Med) - "We find some evidence of a risk of vaccine-induced disease enhancement in seronegative vaccine recipients for dengue serotypes 3 and 4, especially for children under 6 years of age. Because of this, the benefits of vaccination in lower transmission settings are more uncertain, and more data on the long-term efficacy of Qdenga against serotypes 3 and 4 are needed."

Journal • Dengue Fever • Infectious Disease

Vaccination strategies, public health impact and cost-effectiveness of dengue vaccine TAK-003: A modeling case study in Thailand. (PubMed, PLoS Med) - "TAK-003 can considerably reduce dengue burden and lead to cost savings in Thailand. These benefits can be maximized by identifying optimal age cohorts for vaccination and adding catch-up programs. Our model can be used to assess the vaccination impact in other dengue-endemic countries."

HEOR • Journal • Dengue Fever • Infectious Disease • Oncology

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers (clinicaltrialsregister.eu) - P3 | N=212 | Sponsor: Takeda Vaccines, Inc.

New P3 trial • Dengue Fever • Infectious Disease • Pediatrics

PRIME-Q: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia (clinicaltrials.gov) - P=N/A | N=2000 | Recruiting | Sponsor: Takeda | N=10000 ➔ 2000

Adverse events • Enrollment change • Real-world evidence • Dengue Fever

Dengue Vaccine Development and Deployment into Routine Immunization. (PubMed, Vaccines (Basel)) - "Despite decades of research, only two dengue vaccines-CYD-TDV (Dengvaxia) and TAK-003 (Qdenga)-have been licensed to date, with limited implementation...While future vaccines, including mRNA and virus-like particle candidates, are under development, optimizing the use of currently available vaccines is crucial to reducing dengue's public health impact. Given the continued rise in cases, immediate action-combining vaccination with vector control-is essential to prevent further morbidity and mortality."

Journal • Review • Dengue Fever

Development of New Live-Attenuated Vaccine Candidates Lacking Antibody-Dependent Enhancement (ADE) Against Dengue. (PubMed, Vaccines (Basel)) - "Recently, a second licensed dengue vaccine, Qdenga®,Takeda, Singen, Germany), was approved and recommended by the WHO to be administered only in highly dengue-endemic countries, as it was not shown to elicit a robust immune response against DENV-3 and DENV-4 serotypes in dengue seronegative individuals. This review provides current insights to guide the development of a novel live-attenuated tetravalent dengue vaccine candidate that is effective against all DENV serotypes and safe from ADE. The efficacy and safety of the live-attenuated vaccine candidate should be further validated in in vivo studies."

Journal • Review • Dengue Fever • Infectious Disease

Qdenga in Pediatric Dengue Prevention: Real-World Experience from the Vacunar Network in Argentina (ESPID 2025) - "Supported by Takeda."

Clinical • Real-world • Real-world evidence • Dengue Fever

Welcome, Opening Remarks, Video, and Short Intro on Takeda/Qdenga (ESPID 2025) - "Supported by Takeda."

Video • Dengue Fever

0750 - INDUSTRY SYMPOSIUM 09 (NOT INCLUDED IN THE MAIN EVENT CME/CPD CREDIT): Dengue in the Pediatric Population: Burden, Management, and Emerging Solutions (ESPID 2025) - "A key focus is on the real-world experience of Qdenga in dengue prevention, utilizing data from the Vacunar Network in Argentina. The session concludes with an interactive Q&A session."

Clinical • CME • Dengue Fever

A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India (clinicaltrials.gov) - P3 | N=480 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Dengue Fever

Comparison of an Innovative Static Model With Dynamic Adjustment With a Dynamic Model To Assess the Public Health Impact of TAK-003 Vaccination: Case Studies in Thailand and Brazil (ISPOR 2025) - "In both case studies, the dyna-static model yielded results that were comparable to those from the dynamic model, affirming its applicability as a substitute for the dynamic model to inform the impact of TAK-003 vaccination and program design."

Case study • Clinical • Dengue Fever • Infectious Disease

VaQDENV: Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination (clinicaltrials.gov) - P=N/A | N=402 | Recruiting | Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar | Not yet recruiting ➔ Recruiting | Initiation date: Jan 2025 ➔ Jul 2024

Enrollment open • Trial initiation date • Dengue Fever • Infectious Disease

Dengue virus infection in travellers after dengue vaccination, Germany 2023-2024. (PubMed, J Travel Med) - No abstract available

Journal • Dengue Fever • Infectious Disease

The Genetic Evolution of DENV2 in the French Territories of the Americas: A Retrospective Study from the 2000s to the 2024 Epidemic, Including a Comparison of Amino Acid Changes with Vaccine Strains. (PubMed, Vaccines (Basel)) - "Overall, these findings provide a current overview of the genomic evolution of DENV2 in the FTA, which is crucial for developing more effective prevention and control strategies and for selecting future vaccines tailored to circulating strains."

Journal • Retrospective data • Dengue Fever

Knowledge-based mitigation of the environmental risk of Orthoflavivirus live-attenuated vaccines by targeting viral encoded determinants for the mosquito attenuated phenotype. (PubMed, Vaccine) - "The mosquito-attenuated phenotype also ensures the safety of the licensed LAVs IMOJEV, Dengvaxia and QDENGA...This review discusses knowledge of orthoflaviviral encoded determinants for infection and dissemination in mosquito tissues which have potential utility for the rational design of candidate LAVs. Several attenuating mutations discovered to date are located within genomic regions that are conserved among orthoflaviviruses and can potentially support the establishment of a broadly effective attenuating strategy."

Journal • Review • CNS Disorders • Infectious Disease

TAK-003: development of a tetravalent dengue vaccine. (PubMed, Expert Rev Vaccines) - "Effectiveness in a real world setting and safety will be monitored in ongoing and future studies, particularly for DENV-3 and DENV-4, together with the impact of a booster dose. Overall, TAK-003 shows promise as a new tool for dengue prevention."

Journal • Review • Dengue Fever

Efficacy, Immune Response, and Safety of Dengue Vaccines in Adolescents: A Systematic Review. (PubMed, Rev Med Virol) - "This systematic review assesses the efficacy, immune response and safety of dengue vaccines (Qdenga (TAK-003) and Dengvaxia (CYD-TDV)) in adolescents against the need for evidence-based data for dengue vaccination strategies...These findings highlighted the importance of TAK-003 and CYD-TDV in reducing the impact of dengue, especially in endemic regions. Ongoing research is essential to refine vaccine deployment strategies, optimise protection across diverse populations, and address outstanding concerns regarding long-term immunity and safety in seronegative individuals."

Journal • Review • Dengue Fever • Pain

Travel medicine providers' opinions on the dengue vaccine TAK-003 as a travel vaccine and the need for decision-support information and materials before its launch in Japan. (PubMed, Hum Vaccin Immunother) - "The primary reasons for not recommending it were concerns about efficacy and safety, which were also the most requested support information. These findings suggest that many travel medicine providers have positive opinions on TAK-003 as a travel vaccine and need decision-support information and materials."

Journal • Launch Japan • Dengue Fever • Infectious Disease

A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years) (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Mar 2026 ➔ Apr 2027 | Initiation date: Mar 2025 ➔ Apr 2026 | Trial primary completion date: Mar 2026 ➔ Apr 2027

Trial completion date • Trial initiation date • Trial primary completion date • Dengue Fever

Nonstructural Protein 1 (NS1) - and Envelope Protein Domain III (EDIII) - specific antibody responses in QDENGA®-vaccinated Dengue virus (DENV)-naive and -preimmune individuals (ESCMID Global 2025) - No abstract available

Clinical • Late-breaking abstract • Dengue Fever

DENG-VAC study: preliminary data on immunogenity and reactogenity of Qdenga vaccine versus natural infection (ESCMID Global 2025) - No abstract available

Infectious Disease

Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina. (clinicaltrials.gov) - P=N/A | N=112345 | Active, not recruiting | Sponsor: Fundación Vacunar

New trial • Dengue Fever

A Study in Children and Adolescents on the Effectiveness of Takeda's Licensed Dengue Vaccine TDV Against Hospitalization Due to Dengue Disease (clinicaltrials.gov) - P=N/A | N=70000 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Dengue Fever • Pediatrics

Operational challenges and lessons learned from conducting febrile surveillance in a long-term randomized dengue vaccine trial in Latin America and Asia-Pacific. (PubMed, Travel Med Infect Dis) - P3 | "The design of the febrile surveillance protocol ensured high compliance in the trial. Maintaining engagement and access to healthcare beyond the protocol was important in improving febrile case evaluation ≤5 days of fever onset."

Journal • Dengue Fever • Infectious Disease • Novel Coronavirus Disease

Estimated Efficacy of TAK-003 Against Asymptomatic Dengue Infection in Children/Adolescents Participating in the DEN-301 Trial in Asia Pacific and Latin America. (PubMed, J Infect Dis) - P3 | "The variability in VE algorithms indicates challenges in accurately assessing VE against asymptomatic infections. TAK-003 had a modest impact on asymptomatic dengue infections in the first months post-vaccination, mainly in baseline seropositive participants."

Journal • Dengue Fever • Infectious Disease