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NCT03160339

A Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047

Terminated Phase 1 Last updated 18 March 2024
What this trial tests

Phase 1 trial testing PXVX0047 Vaccine in Adenoviral Infection in 25 participants. Terminated before completion.

Timeline
1 May 2017
Primary endpoint
27 November 2017
27 November 2017

Quick facts

Lead sponsorEmergent BioSolutions
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment25
Start date1 May 2017
Primary completion27 November 2017
Estimated completion27 November 2017
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emergent BioSolutions — full company profile →

Who can join

Adults 18 to 35, any sex, with Adenoviral Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine \[A549 Cells\], Live, Oral) is an investigational vaccine in development for the indication of active immunization against adenovirus infection. The primary goals of this Phase 1 study are to evaluate safety, pharmacodynamics (viral shedding), and immunogenicity of PXVX0047.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Noninvasive vaccination against infectious diseases.
    Zheng Z, Diaz-Arévalo D, Guan H, Zeng M. · · 2018 · cited 46× · PMID 29624470 · DOI 10.1080/21645515.2018.1461296
  2. Recent advances of engineered oncolytic viruses-based combination therapy for liver cancer.
    Zhang J, Xiao Y, Zhang J, Yang Y, et al · · 2024 · cited 8× · PMID 38167076 · DOI 10.1186/s12967-023-04817-w
  3. Differential Genome Replication of a Unique Single-Amino-Acid Mutation in the Adenovirus-4 Component of the Live Oral Adenovirus Type 4 and Type 7 Vaccine.
    Collins ND, Beaty S, Wallace E, Li Y, et al · · 2023 · cited 1× · PMID 37514960 · DOI 10.3390/vaccines11071144
  4. 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 S, Collins N, Karasavvas N, Kuschner R, et al · · 2023 · cited 1× · PMID 37376480 · DOI 10.3390/vaccines11061091

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Other Emergent BioSolutions trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03160339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing