Date: 2016-01-14
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Butantan Institute (Brazil)
Product: TV003
Action
mechanism: vaccine
Disease: dengue fever
Therapeutic area: Infectious diseases
Country: Brazil
Trial
details: This randomized, multicenter, double-blind, placebo-controlled Phase III study will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute. The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there\'s dengue transmission. Study\'s intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants. For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start. The study\'s hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy. All participants will be followed up for five years to verify dengue incidence, regardless severity. (NCT02406729)
Latest
news: * On January 14, 2016, the National Institutes of Health (NIH) announced that a large-scale clinical trial to evaluate whether a candidate vaccine can prevent the mosquito-borne illness dengue fever has been launched in Brazil. The vaccine, TV003, was developed by scientists in the laboratory of Stephen Whitehead, Ph.D., at NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The Butantan Institute, a non-profit producer of immunobiologic products for Brazil, licensed the NIAID dengue vaccine technology and is sponsoring the placebo-controlled, multi-center Phase 3 trial using test vaccine produced in Sao Paulo. The new trial aims to enroll almost 17,000 healthy people aged 2 to 59 years in 13 cities, beginning in Sao Paulo. Two-thirds of the volunteers will receive a single dose of the candidate vaccine, while one-third will receive an inactive placebo injection. Neither participants nor study staff will know which of the two groups a volunteer is in. All volunteers will be monitored for five years through a combination of in-person visits to the health clinic and telephone or text communications from the investigators. The goal of the trial is determine if the candidate vaccine prevents dengue fever and to provide additional information about its safety. Although the trial is scheduled to last five years, the investigators hope to have early indications of the potential efficacy of the vaccine in less than two years. The principal investigator is Alexander Precioso, M.D., Ph.D., of the Butantan Institute.
