Current innovation is not only limited to Covid-19 but to multiple diseases. That is why the news of the development of a new quadrivalent dengue vaccine that could very soon become a reality has caused enthusiasm. In a phase III clinical study, after 36 months of follow-up, it showed an efficacy of 62% in the prevention of symptomatic dengue caused by any of the 4 serotypes in joint analysis in the research participants with or without previous exposure to dengue. . In addition to reducing the level of hospitalizations by 83.6% and reducing the development of the hemorrhagic form of the disease by 65.4%.
The data were presented at the international medical congress held at the Congress of the Latin American Society of Pediatric Infectious Diseases (SLIPE) from October 13 to 15, 2021 and recently published in the prestigious scientific journal Clinical Infectious Diseases (CID).
How does it work?
The research, called the ‘Efficacy Study on Tetravalent Immunization against Dengue’ (TIDES) aims to evaluate the efficacy, safety and immunogenicity of a two-dose vaccination scheme with an interval of three months between each application of one Takeda’s candidate vaccine named TAK-003 in the prevention of contagion and in the reduction of the severity of the infection by the 4 serotypes of dengue. It represents the largest clinical intervention study carried out by Takeda to date: it includes the long-term follow-up of more than 20 thousand healthy children and adolescents aged 4 to 16 years from countries with endemic dengue in Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka).
“We are very satisfied with the results that have been observed with this vaccine, which not only helps protect against contagion, but also reduces the severity of the infection, with very good levels of tolerability and few side effects,” said Dr. Pío. López, pediatric infectologist, member of the Scientific Advisory Committee of Congress and President of the Board of Directors of the Latin American Society of Pediatric Infectology (SLIPE).
Favorable results
The new quadrivalent dengue vaccine TAK-003 is based on a live attenuated dengue serotype 2 virus, which provides the genetic ‘backbone’ to generate immunity against the four serotypes covered by the vaccine. The phase III TIDES clinical trial constitutes a double-blind, randomized and controlled investigation against placebo, with the objective of evaluating the safety and efficacy of 2 doses of TAK-003 in the prevention of symptomatic, laboratory-confirmed dengue of any severity and due to any of the four dengue virus serotypes in children and adolescents.
The trial included both seropositive (previously exposed to the virus) and seronegative participants, with a statistically significant level of efficacy at 3 years after vaccination of 65% for the former (varying according to the dengue serotype of each individual) and 54.3 % for seronegative.
Study participants were randomly assigned to receive 0.5 ml of TAK-003 or placebo by subcutaneous injection on days 1 and 90. The study consists of five parts: the first part and the primary endpoint analysis evaluated the efficacy of the vaccine (EV) and its safety in the 15 months after the first dose (12 months after the second dose); the second part of the study continued for another six months to complete the evaluation of secondary endpoints of VE by serotype, baseline serostate, and severity, including VE against dengue hospitalizations; part 3, currently in progress, assesses VE and long-term safety by following up participants for another three years after part 2; while part 4 will assess the safety for 13 months after a booster dose given 48 to 54 months after the initial vaccination and part 5 will analyze the long-term safety for a year after the completion of part 4. In terms In terms of safety, TAK-003 was generally well tolerated, and no significant safety risks have been observed to date in the TIDES trial.
The new tetravalent candidate vaccine against dengue TAK-003 was submitted for approval by the health authority of the European Union (EMA) and in several dengue endemic countries, including Argentina, Brazil and Colombia. It is estimated that it will be submitted for approval by the United States Food and Drug Administration (FDA) by the end of the year.