Butantan-DV Dengue Vaccine Clinical Trials, Dosage, Indication, News, Side Effects

Butantan Institute's single-dose, tetravalent, live, attenuated Butantan-DV Dengue Vaccine is conducting phase 3 clinical trials as of April 2024. The attenuated dengue vaccine results from a partnership between Butantan, the U.S. NIH (National Institutes of Health, USA), and the American Type Culture Archive (ATCC). Butantan-DV is made up of genetically attenuated viruses to protect against four types of dengue viruses.

Development of the tetravalent dengue vaccine began at Butantan Institute in 2010 with FAPESP's support, using a formulation created by researchers affiliated with the NIH. Human phase 1 clinical trials in Brazil started in 2013, with the support of the Butantan Foundation and Brazil's national development bank, BNDES.

Butantan-DV Dengue Vaccine Availability 2024

Butantan Institute plans to submit a report to Brazil's health surveillance agency, ANVISA, in 2024 to apply for the vaccine's registration. 

Butantan-DV Dengue Vaccine Dosage

Butantan-DV Dengue Vaccine is a single dose administration.

Butantan-DV Dengue Vaccine Indication

Butantan-DV Dengue Vaccine offers people protection against four types of the dengue virus.

Butantan-DV Dengue Vaccine Side Effects

In a phase 3 study, solicited systemic vaccine- or placebo-related adverse events within 21 days after injection were more common with Butantan-DV than with placebo (58.3% of participants vs. 45.6%).

Butantan-DV Dengue Vaccine News

February 1, 2024 - The New England Journal of Medicine published Phase 3 clinical trial data. The dengue vaccine is safe for participants who have had dengue and those who have never been exposed to the virus before.

December 16, 2022 - The Butantan-DV dengue vaccine under development by the Butantan Institute shows 79.6% overall efficacy to prevent the disease, according to initial phase 3 clinical study results. During the two-year follow-up of the volunteers, there were no cases of severe dengue fever or alarm signs.

Butantan-DV Dengue Vaccine Clinical Trials

ClinicalTrials.gov ID NCT02406729 - Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Immunogenicity of the Dengue 1, 2, 3, 4 (Attenuated) Vaccine From Instituto Butantan. This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate the efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by the Butantan Institute. Over a 3-year enrollment period, 16,235 participants received either Butantan-DV (10,259 participants) or a 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. Vaccine efficacy was 80.1% (95% CI, 66.0 to 88.4) among participants 2 to 6 years of age, 77.8% (95% CI, 55.6 to 89.6) among those 7 to 17 years of age, and 90.0% (95% CI, 68.2 to 97.5) among those 18 to 59 years of age. Efficacy against DENV-1 was 89.5% (95% CI, 78.7 to 95.0), and against DENV-2 was 69.6% (95% CI, 50.8 to 81.5). DENV-3 and DENV-4 were not detected during the follow-up period.

ClinicalTrials.gov ID NCT01696422 - This is a phase II step-wise, randomized, multicenter, double-blind, and controlled clinical trial to evaluate the safety and immunogenicity of an attenuated tetravalent lyophilized dengue vaccine manufactured by Butantan Institute. Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received a placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received a placebo. Butantan-DV and TV003 were immunogenic and well-tolerated; no severe adverse reactions were observed. In step A, the rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4.