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.
David Alexanderian, Fabiano Ramos, Soumya Chatterjee et al.
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In 30 seconds
This randomized, double-blind, active-comparator phase 2 trial compared the safety and immunogenicity of single-dose quadrivalent dengue vaccines V181 and Butantan-DV in healthy adults in Brazil. Among 1364 participants assigned equally between the vaccines, V181’s day-28 neutralizing-antibody geometric mean titers met noninferiority criteria for DENV-1 and DENV-2, but not DENV-3 or DENV-4. Seroconversion rates met noninferiority criteria for all four serotypes. Both vaccines were generally well tolerated, and most participants developed a trivalent or tetravalent antibody response.
Key findings
- Among 1364 participants, V181 met GMT-ratio noninferiority criteria for DENV-1 and DENV-2, but not DENV-3 or DENV-4.
- Seroconversion rates were noninferior for V181 versus Butantan-DV across DENV-1 to DENV-4.
- Most participants developed a trivalent or tetravalent neutralizing-antibody response; vaccine viremia was detected for each serotype.
- Both vaccines were generally well tolerated, with V181’s safety profile described as comparable to Butantan-DV.
Why it matters
The findings provide comparative phase 2 evidence that V181 can induce antibody responses to all four dengue serotypes, while also showing that immune-response comparisons depend on the measure used: GMT noninferiority was not established for two serotypes, whereas seroconversion noninferiority was established for all four. The generally comparable tolerability supports further evaluation, but these results do not establish clinical protection against dengue.
What to keep in mind
The abstract reports immunogenicity and safety outcomes through day 28, not clinical protection against dengue or longer-term outcomes.