Monday, March 4, 2024
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HomeLifestyleButantan-Dengue vaccine effective in preventing symptomatic dengue | 2 minute medicine

Butantan-Dengue vaccine effective in preventing symptomatic dengue | 2 minute medicine


1. In this randomized controlled trial, Butantan-Dengue Vaccine (Butantan-DV) was effective in preventing virologically confirmed symptomatic dengue after two years, regardless of baseline serological status.

2. Butantan-DV was effective against DENV-1 and DENV-2 serotypes in all age groups.

Evidence Rating Level: 2 (good)

Study summary: Dengue is a mosquito-borne viral disease that can cause high fever and is commonly found in Southeast Asia and South and Central America. There are currently two licensed live attenuated dengue vaccines, including CYD-TDV and TAK-003, but both require multiple doses and serve a limited age group. Butantan-DV is a quadrivalent, live, attenuated, single-dose dengue vaccine candidate that elicited immune responses in all four DENV serotypes and had an acceptable side effect profile regardless of baseline serostatus in a recent phase 2 trial in Brazil. This phase 3 trial investigated the efficacy and safety of Butantan-DV in preventing dengue over two years of follow-up. Overall, the vaccine was effective in preventing virologically confirmed symptomatic dengue after two years, regardless of baseline serostatus. Additionally, it was effective against DENV-1 and DENV-2 serotypes and in all age groups in the trial (2 to 6 years, 7 to 17 years, and 18 to 59 years). The incidence of serious adverse events was similar in both the vaccine and placebo groups, although mild to moderate adverse events were more common with Butantan-DV. Knowledge about vaccine efficacy against DENV-3 and DENV-4 is limited as these serotypes have not been observed during the follow-up period, and long-term data and analyzes over five years of follow-up, such as recommends the World Council. Health Organization, it is necessary.

Click to read the study at NEJM

Relevant reading: Effect of dengue serostatus on dengue vaccine safety and efficacy

In depth (randomized controlled trial): DEN-03-IB is an ongoing phase three, double-blind, randomized controlled trial in Brazil, with five years of planned follow-up, which aimed to investigate the efficacy and safety of Butantan-DV against symptomatic dengue during two years of follow-up. . -above. Participants were eligible for the trial if they were between 2 and 59 years of age and were healthy or had clinically controlled disease. Participants were stratified into three age groups (2 to 6 years, 7 to 17 years, and 18 to 59 years) and randomized in a 2:1 ratio to receive a single dose of Butantan-DV or placebo. A blood sample was obtained before injection to determine the baseline serological status of each participant. The primary efficacy endpoint was virologically confirmed symptomatic dengue occurring more than 28 days after injection. Secondary endpoints included confirmed dengue based on viral serotype and baseline serostatus. A total of 16,235 participants underwent randomization (10,259 in the vaccine group and 5,976 in the placebo group), and almost half of these individuals had a negative HIV status. Overall, vaccine efficacy against any DENV serotype was 79.6% (95% confidence interval (CI): 70.0 to 86.3). Vaccine efficacy against DENV-1 and DENV-2 was 89.5% (95% CI: 78.7 to 95.0) and 69.6% (95% CI: 50.8 to 81). ,5), respectively. Vaccine efficacy against any serotype among those without prior dengue exposure was 73.6% (95% CI, 57.6 to 83.7), while among those with prior exposure it was 89.2%. (95% CI, 77.6 to 95.6). The incidence of serious adverse events occurring within 21 days after injection was 0.2% and 0.1% in the vaccine and placebo groups, respectively. In summary, this phase 3 trial demonstrated that a single dose of Butantan-DV was safe and effective in preventing symptomatic DENV-1 and DENV-2 over 2 years of follow-up, regardless of baseline dengue serostatus.

Image: PS

©2024 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without the express written consent of 2 Minute Medicine, Inc. See licensing here. No article should be construed as medical advice and is not intended to be so by the authors or 2 Minute Medicine, Inc.



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