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Immunogenicity of a Live-Attenuated Dengue Vaccine Using a Heterologous Prime-Boost Strategy in a Phase 1 Randomized Clinical Trial.
Lin, Leyi; Koren, Michael A; Paolino, Kristopher M; Eckels, Kenneth H; De La Barrera, Rafael; Friberg, Heather; Currier, Jeffrey R; Gromowski, Gregory D; Aronson, Naomi E; Keiser, Paul B; Sklar, Marvin J; Sondergaard, Erica L; Jasper, Louis E; Endy, Timothy P; Jarman, Richard G; Thomas, Stephen J.
Afiliação
  • Lin L; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Koren MA; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Paolino KM; Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Eckels KH; Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • De La Barrera R; Pilot Bioproduction Facility, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Friberg H; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Currier JR; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Gromowski GD; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Aronson NE; Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.
  • Keiser PB; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Sklar MJ; Naval Medical Research Center, Silver Spring, Maryland, USA.
  • Sondergaard EL; Clinical Trials Center, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Jasper LE; US Army Medical Materiel Development Activity, Frederick, Maryland, USA.
  • Endy TP; SUNY Upstate Medical University, Institute for Global Health and Translational Sciences, Syracuse, New York, USA.
  • Jarman RG; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
  • Thomas SJ; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.
J Infect Dis ; 223(10): 1707-1716, 2021 05 28.
Article em En | MEDLINE | ID: mdl-32966573
BACKGROUND: Dengue is a global health problem and the development of a tetravalent dengue vaccine with durable protection is a high priority. A heterologous prime-boost strategy has the advantage of eliciting immune responses through different mechanisms and therefore may be superior to homologous prime-boost strategies for generating durable tetravalent immunity. METHODS: In this phase 1 first-in-human heterologous prime-boost study, 80 volunteers were assigned to 4 groups and received a tetravalent dengue virus (DENV-1-4) purified inactivated vaccine (TDENV-PIV) with alum adjuvant and a tetravalent dengue virus (DENV-1-4) live attenuated vaccine (TDENV-LAV) in different orders and dosing schedules (28 or 180 days apart). RESULTS: All vaccination regimens had acceptable safety profiles and there were no vaccine-related serious adverse events. TDEN-PIV followed by TDEN-LAV induced higher neutralizing antibody titers and a higher rate of tetravalent seroconversions compared to TDEN-LAV followed by TDEN-PIV. Both TDEN-PIV followed by TDEN-LAV groups demonstrated 100% tetravalent seroconversion 28 days following the booster dose, which was maintained for most of these subjects through the day 180 measurement. CONCLUSIONS: A heterologous prime-boost vaccination strategy for dengue merits additional evaluation for safety, immunogenicity, and potential for clinical benefit. CLINICAL TRIALS REGISTRATION: NCT02239614.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article