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Integrated immunogenicity analysis of a tetravalent dengue vaccine up to 4 y after vaccination.
Vigne, Claire; Dupuy, Martin; Richetin, Aline; Guy, Bruno; Jackson, Nicholas; Bonaparte, Matthew; Hu, Branda; Saville, Melanie; Chansinghakul, Danaya; Noriega, Fernando; Plennevaux, Eric.
Afiliação
  • Vigne C; a Research & Development , Sanofi Pasteur , Marcy l'Etoile , France.
  • Dupuy M; a Research & Development , Sanofi Pasteur , Marcy l'Etoile , France.
  • Richetin A; a Research & Development , Sanofi Pasteur , Marcy l'Etoile , France.
  • Guy B; a Research & Development , Sanofi Pasteur , Marcy l'Etoile , France.
  • Jackson N; a Research & Development , Sanofi Pasteur , Marcy l'Etoile , France.
  • Bonaparte M; b Global Clinical Immunology Department , Sanofi Pasteur , Swiftwater , PA , USA.
  • Hu B; b Global Clinical Immunology Department , Sanofi Pasteur , Swiftwater , PA , USA.
  • Saville M; c Chief Medical Office , Sanofi Pasteur , Lyon , France.
  • Chansinghakul D; d Research & Development , Sanofi Pasteur , Lumphini, Pathum Wan , Bangkok , Thailand.
  • Noriega F; e Research & Development , Sanofi Pasteur , Swiftwater , PA , USA.
  • Plennevaux E; a Research & Development , Sanofi Pasteur , Marcy l'Etoile , France.
Hum Vaccin Immunother ; 13(9): 2004-2016, 2017 09 02.
Article em En | MEDLINE | ID: mdl-28598256
Two large pivotal phase III studies demonstrated the efficacy of the tetravalent dengue vaccine (CYD-TDV; Dengvaxia®, Sanofi Pasteur) against all dengue serotypes. Here we present an unprecedented integrated summary of the immunogenicity of CYD-TDV to identify the parameters driving the neutralizing humoral immune response and evolution over time. We summarized the immunogenicity profiles of a 3-dose schedule of CYD-TDV administered 6 months apart across 10 phase II and 6 phase III trials undertaken in dengue endemic and non-endemic countries. Dengue neutralizing antibody titers in sera were determined at centralized laboratories using the 50% plaque reduction neutralization test (PRNT50) at baseline, 28 d after the third dose, and annually thereafter for up to 4 y after the third dose in some studies. CYD-TDV elicits neutralizing antibody responses against all 4 dengue serotypes; geometric mean titers (GMTs) increased from baseline to post-dose 3. GMTs were influenced by several parameters including age, baseline dengue seropositivity and region. In the 2 pivotal studies, GMTs decreased initially during the first 2 y post-dose 3 but appear to stabilize or slightly increase again in the third year. GMTs persisted 1.2-3.2-fold higher than baseline levels for up to 4 y post-dose 3 in other studies undertaken in dengue endemic countries. Our integrated analysis captures the fullness of the CYD-TDV immunogenicity profile across studies, age groups and regions; by presenting the available data in this way general trends and substantial outliers within each grouping can be easily identified. CYD-TDV elicits neutralizing antibody responses against all dengue serotypes, with differences by age and endemicity, which persist above baseline levels in endemic countries.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dengue / Vírus da Dengue / Vacinas contra Dengue / Anticorpos Neutralizantes / Imunogenicidade da Vacina / Anticorpos Antivirais Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Adolescent / Adult / Child / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dengue / Vírus da Dengue / Vacinas contra Dengue / Anticorpos Neutralizantes / Imunogenicidade da Vacina / Anticorpos Antivirais Tipo de estudo: Clinical_trials / Observational_studies / Prognostic_studies Limite: Adolescent / Adult / Child / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2017 Tipo de documento: Article