Evidence map›Paper›PMID 37376480›Full record

ArticleVaccines2023

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 and 6 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03160339 (A Phase 1 Two-Arm, Randomized, Double-blind, Active-controlled Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03160339 phase1terminatednot on this map

A Phase 1 Two-Arm, Randomized, Double-blind, Active-controlled Study to Assess the Safety, Pharmacodynamics, and Immunogenicity of PXVX0047 (Adenovirus Type 4 and Type 7 Vaccine [A549 Cells], Live, Oral)

TypeinterventionalSponsorEmergent BioSolutionsRan2017 to 2017Enrolled25ConditionsAdenoviral InfectionArmsPXVX0047 Vaccine, Teva Ad4/Ad7 Vaccine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Shannon BeatyEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Natalie CollinsWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.
Nicos KarasavvasWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.
Robert KuschnerWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.
Jun HangWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.ORCID 0000-0002-6597-7045
Anima AdhikariWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.
Irina Maljkovic BerryWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.ORCID 0000-0001-8555-5352
Christian FungWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.
Shannon WallsWalter Reed Army Institute of Research, Bethesda, MD 20814, USA.
Elena BetancourtEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Jason MendyEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Michael LockEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Emma GiermanEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Sean BennettEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Paul ShabramEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Kelly WarfieldEmergent BioSolutions Inc., Gaithersburg, MD 20879, USA.
Emergent BioSolutions (United States) · USWalter Reed Army Institute of Research · US

Funding

Office of the Secretary of Defense W81XWH-17-2-0074United States Army Medical Research and Development Command W81XWH-16-C-0055
6 · The paper itself

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.

Indexed as

adenovirusclinical trialDNA virusmutationpreterminal proteinvaccine

Identifiers

PMID37376480
PMCPMC10301169
OpenAlexW4380369419

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.