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

Adverse Events and Immunization Errors Following a Mass Immunization Campaignwith TAK-003 in Dourados, Brazil: A Post-Marketing Safety Surveillance Analysis. (PubMed, J Med Virol) - "This descriptive observational study based on post-marketing surveillance data evaluates adverse events following immunization (AEFI) associated with the TAK-003 (Qdenga®) vaccine...TAK-003 demonstrated a favorable safety profile, consistent with clinical trial findings, characterized predominantly by mild, self-limiting adverse events, with serious adverse events occurring infrequently. These findings underscore the importance of enhanced training protocols, robust surveillance systems, and timely reporting to optimize vaccine safety and maintain public trust."

Adverse events • Journal • Observational data • P4 data • Pain

Comprehensive Safety Evaluation of Takeda's Dengue Vaccine (TAK-003): Insights from Long-Term Clinical Trials and Postmarketing Surveillance (ASTMH 2025) - "The TAK-003 postmarketing safety profile was largely consistent with clinical trial data. These combined data indicate that the benefit-risk profile of TAK-003 remains positive."

Clinical • Late-breaking abstract • P4 data • Dengue Fever • Dermatology • Fatigue • Hematological Disorders • Musculoskeletal Pain • Pruritus • Thrombocytopenia

Comprehensive Safety Evaluation of Takeda's Dengue Vaccine (TAK-003): Insights from Long-Term Clinical Trials and Postmarketing Surveillance (ASTMH 2025) - "The TAK-003 postmarketing safety profile was largely consistent with clinical trial data. These combined data indicate that the benefit-risk profile of TAK-003 remains positive."

Clinical • Late-breaking abstract • P4 data • Dengue Fever • Dermatology • Fatigue • Hematological Disorders • Musculoskeletal Pain • Pruritus • Thrombocytopenia

Examining perceptions of the newly available dengue vaccine (Qdenga) in the endemic city of Iquitos, Peru (ASTMH 2025) - "The results from the FGDs will be shared with the MINSA partners to inform how they can maximize vaccine interest and uptake. The goal is to use implementation science framework to strengthen local vaccine outreach strategies."

Dengue Fever

Safety, Long-Term Immune Response and Booster Impact of the Tetravalent Dengue Vaccine TAK-003 in Healthy Adults in Dengue Non-Endemic USA (ASTMH 2025) - "NAbs persisted at varying levels for all DENV serotypes up to 42 months after the primary 2-dose TAK-003 vaccination schedule. A single TAK-003 booster dose, given at 36 months, was well tolerated and elicited a favorable immune response."

Clinical • Dengue Fever

Safety evaluation of Qdenga in travelers from non-endemic areas: results from a multicenter prospective pharmacovigilance study in Spain (ASTMH 2025) - "Administration of Qdenga in adults from non-endemic regions resulted safe in the short-term evaluation after vaccination. Age ≥60 years, co-morbidities and co-administration of other vaccines were not associated with higher risk of developing systemic AE."

Adverse events • Clinical • Dengue Fever • Dermatology • Immunology • Infectious Disease • Urticaria

Differentiating Humoral Immunogenicity Driven by a Live-Attenuated Tetravalent Dengue Vaccine From Prior Dengue Virus Exposure: Key Highlights of Immunological Advantage of TAK-003 Vaccination (ASTMH 2025) - P3 | "Additionally, PCA of the antibody response profile driven by prior dengue exposure and vaccination was comparable. In conclusion, our results provide the first comprehensive insight into humoral immunogenicity characteristics of TAK-003, emphasizing similarities and, more importantly, differences from prior DENV exposure, which likely shape the vaccine's safety, efficacy, and immunogenicity profile."

Dengue Fever • Inflammation

An Open-label Phase 2 trial in Flavivirus-Naive and Dengue-Immune US Healthy Adults: Humoral and T cell Responses to a Tetravalent Dengue Vaccine (TAK-003) (ASTMH 2025) - P2 | "These immunogenicity data support a strong immediate effect of TAK-003 vaccination on humoral and cellular immune responses in FV naive and dengue immune adult participants."

Clinical • P2 data • Dengue Fever • CD4 • CD8 • IFNG

Safety, Long-Term Immune Response and Booster Impact of the Tetravalent Dengue Vaccine TAK-003 in Healthy Adolescents in Dengue Non-Endemic Mexico (ASTMH 2025) - "NAbs persisted at varying levels for all DENV serotypes up to 69 months after the primary 2-dose TAK-003 vaccination schedule. A single TAK-003 booster dose, given at 63 months, was well tolerated and elicited a favorable immune response."

Clinical • Dengue Fever

Beyond Neutralization: A Comprehensive Framework for Evaluating Humoral Immunity Induced by the TAK-003 Dengue Vaccine (ASTMH 2025) - "Serotype correlation per assay type and across different assays showed nonredundant relationships across parameters and variables. In conclusion, these analyses reveal critical, nonoverlapping, unique attributes of TAK-003 humoral immunogenicity, beyond NAbs, and provide a roadmap for future immunological CoP assessments for linking VE and immunogenicity across DENV serotypes and serostatus."

Dengue Fever

Challenges in the Prevention and Treatment of Dengue Fever: An Emerging Issue. (PubMed, Am J Trop Med Hyg) - "Existing vaccines, such as Dengvaxia® (Sanofi Pasteur, Paris, France) and Qdenga® (Takeda Pharmaceutical Company, Tokyo, Japan), have demonstrated some efficacy; however, limitations include a lack of efficacy against certain regional DENV strains and the potential for antibody-dependent enhancement (ADE), particularly in individuals without previous DENV exposure...The intricate pathogenesis of DENV, involving complex virus-host interactions and immune responses, presents additional treatment challenges. In this review, the current challenges and advancements in DF prevention and treatment are examined, emphasizing the limits of existing vaccines and medicines while exploring novel approaches with potential for effectiveness in clinical settings."

Journal • Dengue Fever

The evolution of dengue fever trends in the Central-West Region of Brazil: an 11-year analysis of incidence data from 2013 to 2023 in Mato Grosso do Sul. (PubMed, Int J Infect Dis) - "Dengue is a public health challenge in Mato Grosso do Sul. Preventive interventions are crucial to alleviate disease burden and control outbreaks."

Journal • Dengue Fever

Pathophysiology and clinical implications of dengue-associated neurological disorders. (PubMed, Front Microbiol) - "Although there are still challenges in reaching the ideal vaccination coverage, the introduction of potent vaccines like Dengvaxia and Qdenga provide an achievable option for prevention. Thorough study into DENV's neurological effects and treatment options is essential as the virus's geographic range is increased by climate change and international travel. Reducing the worldwide burden of dengue-related neurological complications requires addressing the intricate interactions between virological, immunological, and environmental variables."

Journal • Review • CNS Disorders • Dengue Fever • Infectious Disease • Inflammation • Multiple Sclerosis • Pain

State of the Art on Vaccine Development Against Dengue Infection: Scoping Review of the Literature. (PubMed, Infect Dis Rep) - "Vaccines were categorized into licensed (CYD-TDV and TAK-003), late-stage (TV003/TV005), and early-stage candidates (TDEN, DPIV, V180, TVDV)...TAK-003 (Qdenga®) demonstrated high efficacy against virologically confirmed dengue (VCD) and dengue-related hospitalization...Currently, TAK-003 is regarded as the best option for broad implementation, while TV003 and TV005 remain promising candidates due to their shorter schedule and robust immunogenicity. Further research is needed to optimize vaccine strategies in seronegative populations, immunocompromised subjects, older adults, and travelers."

Journal • Review • Dengue Fever • Infectious Disease

A retrospective computational validation of a clinically evaluated recombinant envelope protein tetravalent dengue vaccine. (PubMed, Int J Biol Macromol) - "Licensed vaccines like Dengvaxia and Qdenga rely on yellow fever virus (YFV)-based vectors encoding DENV structural proteins, though ADE risks persist. However, limitations in predictive accuracy were noted, such as the erroneous docking of EDE1-C10 to EDIII, highlighting the need for improved modeling approaches incorporating structural dynamics and artificial intelligence (AI) tools. These results support further development of V180 and r2ED, while emphasizing the strengths and boundaries of computational vaccinology."

Journal • Retrospective data • Dengue Fever • Infectious Disease • CD8

Severe Dengue Hemorrhagic Fever After TAK-003 Dengue Vaccination: A Case Report of a Potential Vaccine-Associated Adverse Reaction. (PubMed, Int J Infect Dis) - "Whole-genome sequencing confirmed co-detection of all four dengue serotypes with high similarity to vaccine strains, especially DENV-2. This finding warrants further investigation into a potential association with vaccine adverse events."

Journal • Dengue Fever • Hematological Disorders • Infectious Disease

Dengue virus infection reprograms baseline innate immune gene expression. (PubMed, Med) - "Our findings suggest a lasting effect of DENV infection on the innate immune system that potentially impacts vaccination outcome and secondary dengue pathogenesis."

Journal • Dengue Fever • Infectious Disease

Qdenga-induced dengue caused by minor DENV-2 subvariant(s) in the vaccine, with two amino acid substitutions in the E protein. (PubMed, J Travel Med) - "Comparative sequencing suggests that the vaccine contained a small fraction of identical virus as detected in the patient, suggesting a selection of a DENV-2-substrain with unusual amino acid substitutions. Further research on selection of, and possible effects of, Qdenga-substrain-infections is warranted."

Journal • Dengue Fever • Infectious Disease

A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers (clinicaltrials.gov) - P3 | N=212 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Dengue Fever • Pediatrics

Dengue Vaccines. (PubMed, Curr Top Microbiol Immunol) - "The chapter reviews the historical trajectory and current landscape of vaccine candidates, such as Dengvaxia®, Qdenga®, and Butantan-DV, analyzing their efficacy, safety profiles, and the lessons learned from their clinical trials. It also discusses other hurdles like suitable animal models and viral interference. Ultimately, the chapter highlights the advancements made and outlines future research directions crucial for a universally effective dengue vaccine."

Journal • Dengue Fever

Dengue vaccine rollout in India: lessons for Pakistan's public health preparedness. (PubMed, Ann Med Surg (Lond)) - "India's recent approval of the TAK-003 (Qdenga) dengue vaccine marked a turning point in regional prevention efforts...Integrating school-based immunization programs and mobile outreach for underserved populations can ensure equitable access. With a phased, evidence-based approach rooted in local epidemiology, Pakistan has the opportunity to incorporate dengue vaccination into its broader public health strategy, reducing disease burden and increasing preparedness for future outbreaks."

Journal • Dengue Fever

Refining uncertainty about the TAK-003 dengue vaccine with a multi-level model of clinical efficacy trial data. (PubMed, medRxiv) - "Our results demonstrate that inferences based on complex data from a clinical trial can be sensitive to model structure. Additionally, they reinforce the recommendation from the World Health Organization that use of this vaccine is best suited to high-transmission settings."

Journal • Dengue Fever

Immunogenicity and safety of the live-attenuated tetravalent dengue vaccine (TAK-003) co-administered with recombinant 9-valent human papillomavirus vaccine. (PubMed, Vaccine) - P3 | "These findings support the co-administration of the TAK-003 and 9vHPV vaccines."

Journal • Dengue Fever • Oncology

From controversy to confidence: Strengthening dengue vaccines safety reporting. (PubMed, Vaccine) - "Dengue vaccines-Dengvaxia, Qdenga, and TV003/TV005 (NIH dengue vaccine) -offer potential for control, yet their implementation has been challenged by safety issues, including heightened risks in seronegative individuals, presumably due to antibody-dependent enhancement, though the precise mechanisms remain under investigation...The erosion of public trust following past vaccine controversies highlights the urgent need for transparency to bolster acceptance and inform policy. By integrating advanced surveillance with international cooperation, these measures can refine risk-benefit assessments, rebuild confidence in immunization programs, and maximize the protective impact of dengue vaccines, ultimately reducing the burden on vulnerable populations worldwide."

Journal • Dengue Fever

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults (clinicaltrials.gov) - P3 | N=496 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Dengue Fever