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
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.
Document Details
- Document Type
- Pub Defense Publication
- Publication Date
- Jun 12, 2023
- Source ID
- 10.3390/vaccines11061091
Entities
People
- Anima Adhikari
- Christian Fung
- Elena Betancourt
- Emma Gierman
- Irina Maljkovic Berry
- Jason Mendy
- Jun Hang
- Kelly Warfield
- Michael Lock
- Natalie Collins
- Nicos Karasavvas
- Paul Shabram
- Robert Kuschner
- Sean Bennett
- Shannon Beaty
- Shannon Walls
Organizations
- Emergent BioSolutions
- Office of the Secretary of Defense
- United States Army Medical Research and Development Command
- Walter Reed Army Institute of Research