Phase II Evaluation of the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TetraVax-DV TV005 to Protect Against Infection With Live, Recombinant DENV-2 (rDEN2∆30-7169) Attenuated Strain in a Dengue Endemic Population in South Asia

The primary objective is to determine, among dengue-naïve adults in an endemic population, the protective efficacy of TetraVax-DV TV005 vaccine against dengue infection induced by a live recombinant attenuated rDEN2∆30-7169 attenuated virus strain administered 6, 12, or 24 months after vaccination.
Secondary objectives are:
1. Determine the durability of protection of TetraVax-DV TV005.
2. Evaluate the safety of TetraVax-DV TV005 in dengue-naïve volunteers in a dengue endemic population.
3. Evaluate the safety of the rDEN2∆30-7169 attenuated virus strain in a dengue endemic population.

Start Date11 Dec 2021

Sponsor / Collaborator

University of Vermont

[+1]

NCT03485144 / CompletedPhase 2

A Phase II Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Immunogenicity and Safety of TetraVax-DV in Healthy Adults in Taiwan

The goal of this study is to determine the immunogenicity and safety of TV003(TetraVax-DV), a live attenuated tetravalent dengue vaccine candidate, in healthy human subjects in Taiwan

Start Date12 Dec 2017

Sponsor / Collaborator

Medigen Vaccine Biologics Corp.

NCT02873260 / CompletedPhase 1IIT

A Phase 1 Evaluation of the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TV005 to Protect Against Infection With rDEN3Δ30

This study will evaluate the ability of a single dose of the live attenuated recombinant tetravalent dengue vaccine TetraVax-DV-TV005 (referred to as TV005) to protect against infection with rDEN3Δ30, an attenuated DENV-3, when administered 6 months after the TV005 vaccine.

Start Date01 Aug 2016

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Tetravalent dengue virus vaccine(Instituto Butantan)

100 Translational Medicine associated with Tetravalent dengue virus vaccine(Instituto Butantan)

100 Patents (Medical) associated with Tetravalent dengue virus vaccine(Instituto Butantan)

Literatures (Medical) associated with Tetravalent dengue virus vaccine(Instituto Butantan)

01 Jun 2024·Health Science Reports

Immunization against dengue virus infection is coercive: A timely call

Article

Author: Nahar, Shamsun ; Dewan, Syed M R ; Ahamed, Rayhan ; Bari, Lazima F ; Ahmed, Iftekhar

AbstractBackgroundIn context, the dengue virus causes dengue fever, which is spread by mosquito bites. About 22,000 people every year lose their lives as a direct result of it. Dengue fever has been on the rise recently, and its spread has alarmed health officials throughout the world.DiscussionVaccination is essential for the prevention and management of dengue cases because there is currently no particular cure against dengue virus. The current dengue epidemic calls for urgent action in the form of immunization. However, there are serious drawbacks to using existing vaccines like Dengvaxia. 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.ConclusionThe 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.

14 May 2024·Journal of Virology

A tetravalent dengue virus-like particle vaccine induces high levels of neutralizing antibodies and reduces dengue replication in non-human primates

Article

Author: Urakami, Akane ; Thoresen, Daniel ; Ishikawa, Momoko ; Morita, Kouichi ; Yamamoto, Hiroyuki ; Nomura, Takushi ; Matsuda, Kenta ; Smith, Jonathan F ; Suzaki, Yuriko ; Matano, Tetsuro ; Watanabe, Yuri ; Akahata, Wataru ; Ami, Yasushi ; Moi, Meng Ling ; Ngwe Tun, Mya Myat ; Hau, Trang Thi Thu

ABSTRACT Dengue virus (DENV) represents a significant global health burden, with 50% of the world’s population at risk of infection, and there is an urgent need for next-generation vaccines. Virus-like particle (VLP)-based vaccines, which mimic the antigenic structure of the virus but lack the viral genome, are an attractive approach. Here, we describe a dengue VLP (DENVLP) vaccine which generates a neutralizing antibody response against all four DENV serotypes in 100% of immunized non-human primates for up to 1 year. Additionally, DENVLP vaccination produced no ADE response against any of four DENV serotypes in vitro . DENVLP vaccination reduces viral replication in a non-human primate challenge model. We also show that transfer of purified IgG from immunized monkeys into immunodeficient mice protects against subsequent lethal DENV challenge, indicating a humoral mechanism of protection. These results indicate that this DENVLP vaccine is immunogenic and can be considered for clinical evaluation. Immunization of non-human primates with a tetravalent DENVLP vaccine induces high levels of neutralizing antibodies and reduces the severity of infection for all four dengue serotypes. IMPORTANCEDengue is a viral disease that infects nearly 400 million people worldwide and causes dengue hemorrhagic fever, which is responsible for 10,000 deaths each year. Currently, there is no therapeutic drug licensed to treat dengue infection, which makes the development of an effective vaccine essential. Virus-like particles (VLPs) are a safe and highly immunogenic platform that can be used in young children, immunocompromised individuals, as well as healthy adults. In this study, we describe the development of a dengue VLP vaccine and demonstrate that it induces a robust immune response against the dengue virus for over 1 year in monkeys. The immunity induced by this vaccine reduced live dengue infection in both murine and non-human primate models. These results indicate that our dengue VLP vaccine is a promising vaccine candidate.

01 Feb 2024·The Lancet Infectious Diseases

Safety and durable immunogenicity of the TV005 tetravalent dengue vaccine, across serotypes and age groups, in dengue-endemic Bangladesh: a randomised, controlled trial

Article

Author: Durbin, Anna P ; Carmolli, Marya ; Bak, Dan M ; Diehl, Sean A ; Qadri, Firdausi ; Golam, Kibria ; Alam, Masud ; Kirkpatrick, Beth D ; Whitehead, Stephen S ; Afreen, Sajia ; Walsh, Mary-Claire R ; Alam, Mohammed Shafiul ; Nazib, Forida ; Haque, Rashidul ; Dickson, Dorothy M ; Pierce, Kristen K

BACKGROUNDMorbidity and mortality from dengue virus (DENV) is rapidly growing in the large populations of south Asia. Few formal evaluations of candidate dengue vaccine candidates have been undertaken in India, Pakistan, or Bangladesh. Tetravalent vaccines must be tested for safety and immunogenicity in all age groups and in those previously exposed and naive to DENV infections. TV005 is a live, attenuated tetravalent dengue vaccine. We evaluated the safety and immunogenicity of a single dose of TV005 across age groups in dengue-endemic Bangladesh.METHODSWe performed a randomised, placebo-controlled age de-escalating clinical trial of TV005 at a single clinical site in dengue-endemic Dhaka, Bangladesh, following a technology transfer from the USA. Healthy (as determined by history, clinical examination, and safety laboratory test results) volunteers aged 1-50 years were randomly assigned 3:1 (stratified by four age groups) to receive a single dose of TV005 vaccine or placebo. Participants were followed up for 3 years. The study was double blind and was unmasked at day 180; outcome assessors, clinic staff, and volunteers remained blind throughout. Primary outcomes were safety, evaluated per-protocol as proportion of volunteers with solicited related adverse events of any severity through 28 days post dosing, and post-vaccination seropositivity by day 180 using serotype-specific neutralising antibodies (PRNT₅₀ ≥10). Secondary outcomes included viremia, impact of past dengue exposure, and durability of antibody responses. This study is registered with Clinicaltrials.gov, NCT02678455, and is complete.FINDINGSBetween March 13, 2016, and Feb 14, 2017, 192 volunteers were enrolled into four age groups (adults [18-50 years; 20 male and 28 female], adolescents [11-17 years; 27 male and 21 female], children [5-10 years; 15 male and 33 female], and young children [1-4 years; 29 male and 19 female]) with 48 participant per group. All participants were Bangladeshi. Vaccination was well tolerated and most adverse events were mild. Rash was the most common vaccine-associated solicited adverse event, in 37 (26%) of 144 vaccine recipients versus six (12%) of 48 placebo recipients; followed by fever in seven (5% of 144) and arthralgias in seven (6% of 108), which were only observed in vaccine recipients. Post-vaccine, volunteers of all ages (n=142) were seropositive to most serotypes with 118 (83%) seropositive to DENV 1, 141 (99%) to DENV 2, 137 (96%) to DENV 3, and 124 (87%) to DENV 4, overall by day 180. Post-vaccination, viraemia was not consistently found and antibody titres were higher (10-15-fold for DENV 1-3 and 1·6-fold for DENV 4) in individuals with past dengue exposure compared with the dengue-naive participants (DENV 1 mean 480 [SD 4·0] vs 32 [2·4], DENV 2 1042 [3·2] vs 105 [3·1], DENV 3 1406 [2·8] vs 129 [4·7], and DENV 4 105 [3·3] vs 65 [3·1], respectively). Antibody titres to all serotypes remained stable in most adults (63-86%) after 3 years of follow-up. However, as expected for individuals without past exposure to dengue, titres for DENV 1, 3, and 4 waned by 3 years in the youngest (1-4 year old) cohort (69% seropositive for DENV 2 and 22-28% seropositive for DENV 1, 3, and 4).INTERPRETATIONWith 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.FUNDINGNational Institutes of Health-National Institute of Allergy and Infectious Diseases Intramural Research Program and Johns Hopkins University.TRANSLATIONFor the Bangla translation of the abstract see Supplementary Materials section.

100 Deals associated with Tetravalent dengue virus vaccine(Instituto Butantan)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dengue	NDA/BLA	-	Instituto Butantan	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis


No Data

Tetravalent dengue virus vaccine(Instituto Butantan)

Overview

Basic Info

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation