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A Phase 1 Two-Arm, Randomized, Double-Blind, Active-Controlled Study of Live, Oral Plasmid-Derived Adenovirus Type 4 and Type 7 Vaccines in Seronegative Adults.
Beaty, Shannon; Collins, Natalie; Karasavvas, Nicos; Kuschner, Robert; Hang, Jun; Adhikari, Anima; Maljkovic Berry, Irina; Fung, Christian; Walls, Shannon; Betancourt, Elena; Mendy, Jason; Lock, Michael; Gierman, Emma; Bennett, Sean; Shabram, Paul; Warfield, Kelly.
Afiliação
  • Beaty S; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Collins N; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Karasavvas N; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Kuschner R; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Hang J; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Adhikari A; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Maljkovic Berry I; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Fung C; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Walls S; Walter Reed Army Institute of Research, Bethesda, MD 20814, USA.
  • Betancourt E; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Mendy J; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Lock M; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Gierman E; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Bennett S; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Shabram P; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
  • Warfield K; Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Vaccines (Basel) ; 11(6)2023 Jun 12.
Article em En | MEDLINE | ID: mdl-37376480
ABSTRACT
PXVX0047 is an investigational vaccine developed for active immunization to prevent febrile acute respiratory disease (ARD) caused by adenovirus serotypes 4 (Ad4) and 7 (Ad7). PXVX0047 consists of a modernized, plasmid-derived vaccine that was generated using a virus isolated from Wyeth Ad4 and Ad7 vaccine tablets. A phase 1 two-arm, randomized, double-blind, active-controlled study was conducted to evaluate the safety profile and immunogenicity of the investigational adenovirus vaccines. The two components of PXVX0047 were administered orally together in a single dose to 11 subjects. For comparison, three additional subjects received the Ad4/Ad7 vaccine that is currently in use by the US military. The results of this study show that the tolerability and immunogenicity of the PXVX0047 Ad7 component are comparable with that of the control Ad4/Ad7 vaccine; however, the immunogenicity of the PXVX0047 Ad4 component was lower than expected. Clinical trial number NCT03160339.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Vaccines (Basel) Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Vaccines (Basel) Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Estados Unidos