TetraVax-DV (V180) Dengue Vaccine 2023
Merck & Co and Instituto Butantan co-developed V180 (Butantan-DV and TV003) adjuvanted, tetravalent subunit dengue vaccine candidatecompriseds truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes (DEN-1 strain 258848, DEN-2 strain PR159 S1, DEN-3 strain CH53489, and DEN-4 strain H241). The DEN-80E subunits are expressed from plasmids in the Drosophila S2 cell expression system and are formulated with either ISCOMATRIX (saponin, cholesterol, and phospholipid adjuvant; CSL) or Alhydrogel (aluminum hydroxide gel adjuvant; Brenntag Nordic).
The V180 vaccine was 79.6% effective in preventing dengue, according to a phase 3 clinical study conducted in Brazil. During this period, no serious dengue cases were reported in the participants. The positive result is the result of more than ten years of work with international partners. The phase 3 study is ongoing, and the researchers still intend to generate efficacy data for serotypes 3 and 4.
In the phase 2 clinical trial, whose results were published in an article in The Lancet Infectious Diseases, 80% of the volunteers produced antibodies against the four serotypes.
The dengue vaccine technology was initially developed at the U.S. National Institutes of Health. In November 2016, Medigen Vaccine Biologics entered a license agreement with the US NIH to develop, sell, and sublicense this dengue vaccine to 17 countries.
Instituto Butantan is the largest producer of vaccines and serums in Latin America and the main producer of immunobiological in Brazil.
TetraVax-DV (V180) Vaccine Dosage
V180 is administered as an intramuscular injection, its current three-dose schedule could still be improved to reduce the risk of non-compliance. However, it is believed that V180 would achieve its most significant commercial potential as part of a heterologous prime-boost strategy with TetraVax-DV, which the company has in-licensed from the U.S. National Institutes of Health, potentially simplifying the vaccination schedule to just two doses.
TetraVax-DV (V180) Dengue Vaccine News
December 16, 2022 - Butantan confirmed its dengue vaccine is 79.6% effective in phase 3 study results amidst the explosion of dengue cases in Brazil, data bring a new perspective to the fight against the disease.
April 13, 2022 - A new strain of dengue was detected in Brazil in a man from Aparecida de Goiânia by researchers from the Oswaldo Cruz Foundation and the Central Public Health Laboratory of Goiás. The serotype 2 genotype, also known as the cosmopolitan genotype, is the most widespread dengue virus lineage globally, but it had never been found in the country. Brazil is experiencing an outbreak of the disease, with more than 500,000 cases registered between January and April 2020.
March 24, 2020 - The Lancet published a study: Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomized placebo-controlled phase 2 trial. Butantan-DV and TV003 were safe and induced robust, balanced neutralizing antibody responses against the four DENV serotypes. The efficacy evaluation of the Butantan-DV vaccine is ongoing.
February 15, 2018 - Global Drug Analysis: V180 - More Compact Dosing Schedule Could Make It a More Attractive Alternative to Dengvaxia.
V180 Dengue Vaccine Clinical Trials
Clinical Trial NCT02450838: Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005).
Clinical Trial NCT01477580: Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001) (Completed, No results posted).