TV005 / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Dengue vaccine effectiveness and safety: a systematic analysis of recent clinical trial data. (PubMed, Virol J) - "This review provides a systematic review of the dengue vaccines data available from the last five years highlighting significant progress in vaccine development, efficacy, and safety and TAK-003 showed the greatest efficacy against hospitalized and symptomatic Dengue patients, reducing risk by 85% (RR 0.15; 95% CI 0.07-0.33)."

Journal • Review • Dengue Fever • Infectious Disease

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

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

Advances in the Epidemiology, Pathogenesis, Diagnostic Methods, and Vaccine Development of Dengue Fever: A Comprehensive Review. (PubMed, Viral Immunol) - "In this review, we provide an updated and more in-depth overview of dengue epidemiology and pathogenesis, along with recent progress in diagnostic approaches (including methods to address cross-reactivity with other flaviviruses) and an expanded discussion of current dengue vaccine development, such as CYD-TDV (Dengvaxia), TV003/TV005, and the new TAK-003. This comprehensive perspective aims to offer references for the prevention, clinical diagnosis, and control of the disease."

Journal • Review • Dengue Fever • Infectious Disease

Localized inflammation in dengue vaccine-induced skin rash is not associated with continuous presence of dengue virus genome. (PubMed, J Invest Dermatol) - "Vaccination with the tetravalent live attenuated dengue virus (DENV) vaccines TV003 and TV005 causes a mild, relatively localized erythematous maculopapular skin rash in most dengue-naïve vaccinees. Incidence and severity of lymphocytic infiltration were highest in rash biopsy samples compared to those from non-involved areas in participants experiencing a rash or from those taken from participants not experiencing a rash. These results indicate that the rash associated with infection with live attenuated dengue vaccines or challenge strains is predominantly lymphocyte-driven perivascular dermal inflammation without local concomitant active viral replication."

Journal • Dengue Fever • Dermatology • Infectious Disease • Inflammation

Dengue and severe dengue with neurological complications: a challenge for prevention and control. (PubMed, Arq Neuropsiquiatr) - "The CYD-TDV/Dengvaxia and TAK-003/DENVax vaccines, licensed for use by the Brazilian National Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA, in Portuguese), show efficacy against hospitalizations of 72.7% (95% confidence interval [95%CI]: 62.3-80.3%) and of 90.4% (95%CI: 82.6-94.7%) respectively. The TV003/TV005 vaccine, which is being studied by Intituto Butantan in Brazil, shows promising results, with an efficacy of 79.6% for symptomatic dengue...The main individual protection measure is the use of topical repellents (icaridin). All of these actions represent important tools for the prevention of dengue fever and its neurological complications."

Journal • Review • CNS Disorders • Dengue Fever • Pain

An In Silico Design of a Vaccine against All Serotypes of the Dengue Virus Based on Virtual Screening of B-Cell and T-Cell Epitopes. (PubMed, Biology (Basel)) - "Despite the urgent demand for vaccines in the control of the disease, the two approved vaccines, Dengvaxia and TV003/TV005, there are current questions regarding their effectiveness due to an increased risk of antibody-dependent enhancement (ADE) and reduced protection...Our new vaccine design offers a promising additional option for Dengue virus protection. Further experimental validations will be conducted to confirm its protective efficacy and safety."

Journal • Dengue Fever

Immunization against dengue virus infection is coercive: A timely call. (PubMed, Health Sci Rep) - "Besides, the Qdenga vaccine has not yet been approved by the FDA in the United States. On the other hand, positive results from a phase II randomized and controlled clinical study of the TV005 tetravalent live-attenuated dengue vaccine were recently reported in Bangladesh. Only an effective vaccination can drastically lower dengue infection and mortality rates. The development of safe and effective vaccination, as well as their correct dissemination, is an essential requirement for the people of Bangladesh and the rest of the globe, and we concentrated on this critical problem in this article."

Journal • Dengue Fever • Infectious Disease

Controlled human infection study underpins efficacy of the tetravalent live-attenuated dengue vaccine TV005. (PubMed, J Clin Invest) - "Notably, vaccine recipients also showed serotype-specific efficacy. While long-term studies are still needed, these findings represent an important step in providing protection against dengue virus."

Journal • Allergy • Dengue Fever • Immunology • Infectious Disease

TV005 dengue vaccine protects against dengue serotype 2 and 3 controlled human infection. (PubMed, J Clin Invest) - P1 | "TV005 is a leading tetravalent dengue vaccine candidate which fully protects against infection with DENV2 and DENV3 in an established controlled human infection model.CLINICAL TRIALS REGISTRATION NUMBERS. NCT02317900 and NCT02873260."

Clinical • Journal • Dengue Fever • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Neutropenia

The Dengue-in-Dhaka Initiative: results from a phase 2 trial evaluating the TV005 tetravalent dengue vaccine in Bangladesh. (PubMed, Lancet Infect Dis) - No abstract available

Journal • P2 data • Dengue Fever

Safety and durable immunogenicity of the TV005 tetravalent dengue vaccine, across serotypes and age groups, in dengue-endemic Bangladesh: a randomised, controlled trial. (PubMed, Lancet Infect Dis) - P2 | "With 3 years of follow-up, the single-dose tetravalent dengue vaccine, TV005, was well tolerated and immunogenic for all four serotypes in young children to adults, including individuals with no previous dengue exposure."

Journal • Allergy • Dengue Fever • Immunology • Infectious Disease • Musculoskeletal Pain

A dengue vaccine whirlwind update. (PubMed, Ther Adv Infect Dis) - "While no specific treatments outside of supportive management exist, vaccines are an area of major research with two vaccines, Dengvaxia (CYD-TDV) and Denvax (TAK003), recently licensed for clinical use...Other vaccines including TV003 and TV005 continue to be developed across the world, with the hopes of entering clinical trials in the near future. We discuss the current state of vaccine development against dengue, with a focus on CYD-TDV and TAK003 as promising novel vaccines to target this neglected tropical disease (NTD)."

Journal • Review • Dengue Fever • Hematological Disorders • Infectious Disease

Dengue Controlled Human Infection Model in Dhaka, Bangladesh (clinicaltrials.gov) - P2 | N=192 | Active, not recruiting | Sponsor: Beth Kirkpatrick | Recruiting ➔ Active, not recruiting

Enrollment closed • Dengue Fever • Infectious Disease

Clinical Trial of the Safety and Immunogenicity of a Tetravalent Dengue Virus Vaccine Admixture TV005 in the Elderly Aged 50-70 Years in Taiwan (clinicaltrials.gov) - P2 | N=252 | Completed | Sponsor: National Taiwan University Hospital | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Sep 2022

Trial completion • Trial completion date • Dengue Fever