Vaccine Info

TetraVax-DV (V180) Dengue Vaccine

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Staff
Last reviewed
September 2, 2023
Fact checked by
Robert Carlson, MD
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TetraVax-DV (V180) Dengue Vaccine 2023

Merck & Co., Instituto Butantan, and Medigen Vaccine Biologics (MVB), co-developed TetraVax-DV, V180, Butantan-DV, and TV003) adjuvanted, tetravalent subunit dengue vaccine candidate comprised 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 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. In the phase 2 clinical trial, the results were published in an article in The Lancet Infectious Diseases. According to the clinical study report, no vaccine-related SAEs were observed in 54 subjects aged 20-70. The immunogenicity data demonstrates that the vaccinated group produced higher neutralizing antibody titers (GMTs of PRNT50, and had a higher seropositivity rate against types of Dengue virus than the controlled group. Moreover, the vaccinated group remained expressing neutralizing responses on day 180 and day 365 after vaccination, this result reveals that MVC's dengue vaccine shows immunogenicity not only within 20-50-year-old subjects but also in the elder group aged 51-70 years old.

In November 2016, Medigen Vaccine Biologics entered a license agreement with the U.S. National Institutes of Health (NIH) and American Type Culture Archive, USA, to develop, sell, and sublicense this dengue vaccine to 17 countries. The dengue vaccine technology was initially developed at the U.S. NIH. A clinical trial with 17 thousand volunteers performed in partnership with several national centers is now in its final stage of Anvisa registration.

On December 16, 2022, Merck, known as MSD outside of the United States and Canada, announced, 'We are highly encouraged by the tremendous progress scientists and clinicians at the Instituto Butantan have made in developing their single-dose dengue vaccine candidate.'

Instituto Butantan is the largest producer of vaccines and serums in Latin America and the main producer of immunobiological in Brazil.

MVC is a biopharmaceutical company focusing on developing and mass-producing vaccines and biologics, located at No. 68, Shengyi 3rd Rd., Zhubei City, Hsinchu County 302, Taiwan (R.O.C.)

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. NIH, potentially simplifying the vaccination schedule to just two doses.

TetraVax-DV (V180) Dengue Vaccine News

April 8, 2023 - The phase II study for dengue vaccine in Taiwan and finished the clinical study report. This bridging and proof-of-concept study assessed ethnic differences and evaluated the immunogenicity of the elderly population, which will be used as the basis for an indication expansion to the elderly population.

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 two 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).

Clinical Trials

No clinical trials found