Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
October 1, 2026 · via Europe PMC
Safety and Immunogenicity of the Live-Attenuated Quadrivalent Dengue Vaccine V181 Compared With Butantan-DV Among Healthy Adults in Brazil: A Randomized, Double-Blind, Phase 2 Trial.
Alexanderian D, Ramos F, Chatterjee S, +7 more, V181-002 Team.
AI summary — for doctors, generated from the abstract only
The single-dose dengue vaccine V181 was immunogenic and generally well tolerated, with noninferiority to Butantan-DV for all serotypes by seroconversion but only for DENV-1 and DENV-2 by antibody titers.
What was studied
A randomized, double-blind, active-comparator phase 2 trial in healthy adults in Brazil comparing V181 with Butantan-DV, assessing neutralizing antibody geometric mean titers and seroconversion at day 28 plus vaccine-related serious adverse events and solicited adverse events.
Key findings
- 1364 participants were randomized 1:1 (682 per group)
- By geometric mean titer ratios, V181 was noninferior for DENV-1 and DENV-2 but not DENV-3 and DENV-4
- By seroconversion rates, noninferiority was established for all four serotypes
- Both vaccines were generally well tolerated, and vaccine viremia was detected for each serotype
Clinical relevance
The results support further development of V181 as a single-dose quadrivalent dengue vaccine, though titer results for two serotypes were not noninferior.
Who should care
Limitations
This is a phase 2 trial in healthy adults with immunogenicity (not clinical efficacy) endpoints and 28-day safety follow-up. The abstract does not give numerical titers or adverse event rates.
V181 is a promising dengue vaccine candidate, but its protective efficacy remains to be shown.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background
Dengue is caused by infection with 1 of 4 dengue virus (DENV) serotypes (DENV-1 to DENV-4). V181 and Butantan-Dengue Vaccine (Butantan-DV) are independently developed, single-dose, quadrivalent dengue vaccines based on the same attenuated parental strains.
Methods
In this randomized, double-blind, active comparator-controlled, multisite, phase 2 trial, we compared the safety and immunogenicity of V181 and Butantan-DV in healthy adults in Brazil. The primary immunogenicity objectives were to compare vaccine-induced neutralizing antibody geometric mean titers (GMTs) and seroconversion rates for DENV-1 to DENV-4 at day 28 postvaccination. The primary and secondary safety objectives, respectively, were to assess vaccine-related serious adverse events and the proportion of participants experiencing solicited adverse events through day 28 postvaccination.
Results
Overall, 1364 participants were assigned (1:1) to receive V181 (n = 682) or Butantan-DV (n = 682). At day 28 postvaccination, V181 induced a noninferior immune response to Butantan-DV for DENV-1 and DENV-2 but not DENV-3 and DENV-4, as measured using GMT ratios. Noninferiority was established for all DENV serotypes based on seroconversion rates. Most participants developed a trivalent or tetravalent neutralizing antibody response. Vaccine viremia was detected for each DENV serotype. V181 and Butantan-DV were generally well tolerated.
Conclusions
V181 was immunogenic in adults, and while immunogenicity was noninferior to Butantan-DV for DENV-1 and DENV-2, seroconversion rates were noninferior for DENV-1 to DENV-4. The safety profile of V181 is comparable to that of Butantan-DV and supports its continued evaluation as a single-dose quadrivalent vaccine for dengue prevention.
Clinical trials registration
NCT05710224.
DOI
10.1093/cid/ciag349
PMID
42383822
PMCID
PMC13644855
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
Want more like this?
Browse more from the feed. A free account unlocks the full feed, saving and communities.
Back to the research feed