Evidence map›Paper›PMID 23624851›Full record

Trial reportCancer immunology, immunotherapy : CII2013

Novel adenoviral vector induces T-cell responses despite anti-adenoviral neutralizing antibodies in colorectal cancer patients.

Michael A Morse, Arvind Chaudhry, Elizabeth S Gabitzsch, Amy C Hobeika, Takuya Osada, Timothy M Clay, Andrea Amalfitano, Bruce K Burnett, Gayathri R Devi, David S Hsu and 7 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
7.0field-weighted citation impact, top 3% 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.

NCT01147965 phase1 / phase2completednot on this map

A Phase I/II Study of Active Immunotherapy With Ad5 [E1-,E2b-]-CEA(6D) Vaccine in Patients With Advanced or Metastatic Malignancies Expressing CEA

TypeinterventionalSponsorNantCell, Inc.Ran2010 to 2017Enrolled43ConditionsColorectal Cancer, Lung Cancer, Breast Cancer, Prostate CancerArmsAd5 CEA Vaccine
NCT03050814 phase2terminatednot on this mapstarted 2017, after this paper: background citation

A Randomized Phase II Trial of Standard of Care Alone or in Combination With Ad-CEA Vaccine and Avelumab in Patients With Previously Untreated Metastatic or Unresectable Colorectal Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2017 to 2021Enrolled30ConditionsColorectal Tumors, Colorectal Neoplasms, Colorectal Carcinoma, Colorectal AdenocarcinomaArmsAvelumab, Ad-CEA vaccine, Bevacizumab, 5-Fluorouracil (FU), Leucovorin
NCT03384316 phase1completednot on this mapstarted 2018, after this paper: background citation

Multi-Targeted Recombinant Ad5 (CEA/MUC1/Brachyury) Based Immunotherapy Vaccine Regimen in People With Advanced Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2018 to 2020Enrolled11ConditionsNeoplasms, Prostate Cancer, Lung Cancer, Breast CancerArmsETBX-051, adenoviral brachyury vaccine, ETBX-061, adenoviral Mucin-1 (MUC1) vaccine, ETBX-011
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 91 citations in OpenAlex.

  1. Trial
  2. Targeting Carcinoembryonic Antigen with DNA Vaccination: On-Target Adverse Events Link with Immunologic and Clinical Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016
    Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. CEA vaccines.Human vaccines & immunotherapeutics · 2023
    Review
  20. 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

17 authors at 8 institutions in 4 countries.

Michael A MorseDepartment of Medicine, Duke University Medical Center, Durham, NC 27710, USA. morse004@mc.duke.edu
Arvind Chaudhry
Elizabeth S Gabitzsch
Amy C Hobeika
Takuya Osada
Timothy M Clay
Andrea Amalfitano
Bruce K Burnett
Gayathri R Devi
David S Hsu
Younong Xu
Stephanie Balcaitis
Rajesh Dua
Susan Nguyen
Joseph P Balint
Frank R Jones
H Kim Lyerly
Etubics (United States) · USDuke Medical Center · USDuke Institute for Health Innovation · USDuke Cancer InstituteDuke University Hospital · USGlaxoSmithKline (Belgium) · BEMedical Research Associates · USMichigan State University · US

Funding

Development of a Novel CEA Expressing Ad5 [E1-, E2b-] Vector for TreatmentR44CA134063 · NCI · ETUBICS CORPORATION · PI JONES, FRANK R. · 2009 to 2010
$2.5M
Development of a Novel CEA Expressing Adenovirus for TreatmentR43CA134063 · NCI · ETUBICS CORPORATION · PI JONES, FRANK R. · 2008 to 2008
$113k
NCI NIH HHS HHSN261200900059CNCI NIH HHS HHSN261201100097CNCI NIH HHS R43 CA134063NCI NIH HHS R44 CA134063
6 · The paper itself

Abstract

First-generation, E1-deleted adenovirus subtype 5 (Ad5)-based vectors, although promising platforms for use as cancer vaccines, are impeded in activity by naturally occurring or induced Ad-specific neutralizing antibodies. Ad5-based vectors with deletions of the E1 and the E2b regions (Ad5 [E1-, E2b-]), the latter encoding the DNA polymerase and the pre-terminal protein, by virtue of diminished late phase viral protein expression, were hypothesized to avoid immunological clearance and induce more potent immune responses against the encoded tumor antigen transgene in Ad-immune hosts. Indeed, multiple homologous immunizations with Ad5 [E1-, E2b-]-CEA(6D), encoding the tumor antigen carcinoembryonic antigen (CEA), induced CEA-specific cell-mediated immune (CMI) responses with antitumor activity in mice despite the presence of preexisting or induced Ad5-neutralizing antibody. In the present phase I/II study, cohorts of patients with advanced colorectal cancer were immunized with escalating doses of Ad5 [E1-, E2b-]-CEA(6D). CEA-specific CMI responses were observed despite the presence of preexisting Ad5 immunity in a majority (61.3 %) of patients. Importantly, there was minimal toxicity, and overall patient survival (48 % at 12 months) was similar regardless of preexisting Ad5 neutralizing antibody titers. The results demonstrate that, in cancer patients, the novel Ad5 [E1-, E2b-] gene delivery platform generates significant CMI responses to the tumor antigen CEA in the setting of both naturally acquired and immunization-induced Ad5-specific immunity.

Indexed as

AdenoviridaeAdultAgedAntibodies, NeutralizingCancer VaccinesCarcinoembryonic AntigenCohort StudiesColorectal NeoplasmsDose-Response Relationship, DrugEnzyme-Linked Immunosorbent AssayFemaleGenetic VectorsHumansImmunizationInterferon-gammaKaplan-Meier EstimateAd5(E1-,E2b-)-CEA(6D) vaccineAntibodies, NeutralizingCancer VaccinesCarcinoembryonic AntigenInterferon-gamma

Identifiers

PMID23624851
PMCPMC3732790
OpenAlexW2058451285

What OpenQuestion holds

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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.