TetraVax-DV (V180) Dengue Vaccine Clinical Trials, Dosage, News, Side Effects, Usage

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).

In 2024, according to a phase 3 clinical study conducted in Brazil, the V180 vaccine candidate was found to be 79.6% effective in preventing dengue. 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.

Development of the tetravalent dengue vaccine began at Butantan Institute in 2010 with FAPESP's support (Grant number: 08/50029-7), using a formulation created by researchers affiliated with the US National Institutes of Health (NIH). Clinical trials in Brazil began in 2013, with the support of the Butantan Foundation and BNDES, Brazil's national development bank, under the aegis of the project "Development of a tetravalent dengue vaccine," led by Neuza Frazatti Gallina, winner of the 2023 Péter Murányi Prize.

On December 16, 2022, Merck 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.' In February 2024, infectious disease specialist Esper Kallás informed Agência FAPESP, "In June (2024), we'll complete the five-year follow-up period. Once the data has been consolidated, we'll know how long the vaccine-induced protection will last."

Instituto Butantan, in São Paulo state, Brazil, is the largest producer of vaccines and serums in Latin America and the main producer of immunological products in Brazil. MVC is a biopharmaceutical company focusing on developing and mass-producing vaccines and biologics. It is 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. A single dose schedule was evaluated in the phase 3 study. The two-dose schedule could still be improved to reduce the risk of non-compliance. However, it is believed that V180 would achieve significant commercial potential as part of a heterologous prime-boost strategy.

TetraVax-DV (V180) Dengue Vaccine News

February 1, 2024 - The NEJM published an Original Article - Live, Attenuated, Tetravalent Butantan–Dengue Vaccine in Children and Adults.

April 8, 2023 - The phase II study for the dengue vaccine in Taiwan finished the bridging and proof-of-concept study assessed ethnic differences and evaluated the immunogenicity of the elderly population.

December 16, 2022 - Butantan confirmed its dengue vaccine is 79.6% effective in phase 3 study results.

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 Brazil.

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

ClinicalTrials NCT02406729: Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or placebo (5976 participants). The overall 2-year vaccine efficacy was 79.6% (95% confidence interval [CI], 70.0 to 86.3) — 73.6% (95% CI, 57.6 to 83.7) among participants with no evidence of previous dengue exposure and 89.2% (95% CI, 77.6 to 95.6) among those with a history of exposure.

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).