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

Shannon Beaty; Natalie Collins; Nicos Karasavvas; Robert Kuschner; Jun Hang; Anima Adhikari; Irina Maljkovic Berry; Christian Fung; Shannon Walls; Elena Betancourt; Jason Mendy; Michael Lock; Emma Gierman; Sean Bennett; Paul Shabram; Kelly Warfield

doi:10.3390/vaccines11061091

Vaccines (Jun 2023)

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

Shannon Beaty,
Natalie Collins,
Nicos Karasavvas,
Robert Kuschner,
Jun Hang,
Anima Adhikari,
Irina Maljkovic Berry,
Christian Fung,
Shannon Walls,
Elena Betancourt,
Jason Mendy,
Michael Lock,
Emma Gierman,
Sean Bennett,
Paul Shabram,
Kelly Warfield

Affiliations

Shannon Beaty: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Natalie Collins: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Nicos Karasavvas: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Robert Kuschner: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Jun Hang: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Anima Adhikari: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Irina Maljkovic Berry: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Christian Fung: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Shannon Walls: Walter Reed Army Institute of Research, Bethesda, MD 20814, USA
Elena Betancourt: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Jason Mendy: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Michael Lock: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Emma Gierman: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Sean Bennett: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Paul Shabram: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA
Kelly Warfield: Emergent BioSolutions Inc., Gaithersburg, MD 20879, USA

DOI: https://doi.org/10.3390/vaccines11061091
Journal volume & issue: Vol. 11, no. 6
p. 1091

Abstract

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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.

Published in Vaccines

ISSN: 2076-393X (Online)
Publisher: MDPI AG
Country of publisher: Switzerland
LCC subjects: Medicine
Website: http://www.mdpi.com/journal/vaccines

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