Safety and immunogenicity of a tetravalent dengue vaccine (CYD-TDV) in HIV-positive adults aged 18–50 years in Brazil: Results from a phase II, randomized, observer-blind, placebo-controlled trial Article Swipe
Ana Paula Perroud
,
José Valdez Madruga
,
Luís Gustavo Romani Fernandes
,
Kléber Giovanni Luz
,
Nikola Lukić
,
Sophie Bourée
,
Martín Sánchez-Ruiz
,
Francesco Pegoraro
,
Céline Petit
,
Betzana Zambrano
,
Gustavo H. Dayan
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1080/21645515.2025.2582237
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1080/21645515.2025.2582237
Dengue is a common arboviral infection that poses a serious health concern worldwide, including Latin America. Our study assessed the safety and immunogenicity of CYD-TDV, a recombinant, live-attenuated, tetravalent dengue vaccine, among HIV-infected adults in Brazil, with previous exposure to dengue infection, and maintained on antiretroviral therapy. This observer-blind, placebo controlled, phase II study (NCT02741128) enrolled participants aged 18-50 years, randomized 2:1 to receive CYD-TDV or placebo subcutaneously at 0, 6, and 12 months. Serological assessments were performed using plaque reduction neutralization assays at baseline and 28 days following each vaccination. Overall, 133 participants were randomized (CYD-TDV, n = 89; placebo, n = 44). At day 28, post-initial vaccination, participants receiving CYD-TDV reported 3.11- to 6.37-fold increase in neutralizing antibody geometric mean titers compared with those at baseline across dengue virus serotypes 1-4 but were sustained after 3 doses. No notable immune responses were observed to any of the serotypes in the placebo group. The safety profiles were comparable across both study groups. In the CYD-TDV and placebo groups, pain was the most commonly reported injection site reaction post-first injection in 18.4% and 29.5% participants, respectively. There were no reports of Grade 3 solicited injection site reactions post-CYD-TDV administration. No safety signals were detected after CYD-TDV administration, including immediate unsolicited AEs/ARs, SAEs/AESIs, or HIV-related conditions. None of the participants discontinued the study due to an AE, and no deaths were reported. CYD-TDV demonstrated adequate safety and robust immunogenicity against all dengue serotypes in HIV-positive adults receiving prior antiretroviral treatment.
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- Type
- article
- Language
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- Landing Page
- https://doi.org/10.1080/21645515.2025.2582237
- OA Status
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- References
- 60
- OpenAlex ID
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All OpenAlex metadata
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https://openalex.org/W4416086134Canonical identifier for this work in OpenAlex
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https://doi.org/10.1080/21645515.2025.2582237Digital Object Identifier
- Title
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Safety and immunogenicity of a tetravalent dengue vaccine (CYD-TDV) in HIV-positive adults aged 18–50 years in Brazil: Results from a phase II, randomized, observer-blind, placebo-controlled trialWork title
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articleOpenAlex work type
- Language
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enPrimary language
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2025Year of publication
- Publication date
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2025-11-10Full publication date if available
- Authors
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Ana Paula Perroud, José Valdez Madruga, Luís Gustavo Romani Fernandes, Kléber Giovanni Luz, Nikola Lukić, Sophie Bourée, Martín Sánchez-Ruiz, Francesco Pegoraro, Céline Petit, Betzana Zambrano, Gustavo H. DayanList of authors in order
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https://doi.org/10.1080/21645515.2025.2582237Publisher landing page
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goldOpen access status per OpenAlex
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https://doi.org/10.1080/21645515.2025.2582237Direct OA link when available
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0Total citation count in OpenAlex
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60Number of works referenced by this work
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