Evidence map›Paper›PMID 27886428›Full record

Trial reportOral diseases2017

Immune reactivity after adenoviral-mediated aquaporin-1 cDNA transfer to human parotid glands.

I Alevizos, C Zheng, A P Cotrim, C M Goldsmith, L McCullagh, T Berkowitz, S L Strobl, A Malyguine, W C Kopp, J A Chiorini and 4 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oral diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.1field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Current State of Knowledge on Salivary Gland Cancers.Critical reviews in oncogenesis · 2018
    Review
  8. Article
  9. Article
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

14 authors at 5 institutions in 1 country.

I AlevizosMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
C ZhengMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
A P CotrimMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
C M GoldsmithMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
L McCullaghMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
T BerkowitzDepartment of Biostatistics & Bioinformatics, Duke University Medical Center, Durham, NC, USA.
S L StroblClinical Services Program, Leidos Biomedical Research, Inc, Frederick, MD, USA.
A MalyguineClinical Services Program, Leidos Biomedical Research, Inc, Frederick, MD, USA.
W C KoppClinical Services Program, Leidos Biomedical Research, Inc, Frederick, MD, USA.
J A ChioriniMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
N P NikolovMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
M NeelyDepartment of Biostatistics & Bioinformatics, Duke University Medical Center, Durham, NC, USA.
G G IlleiMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
B J BaumMolecular Physiology and Therapeutics Branch, NIDCR, NIH, Bethesda, MD, USA.
National Institute of Dental and Craniofacial Research · USLeidos (United States) · USDuke Medical Center · USDuke University Hospital · USLeidos Biomedical Research Inc. (United States)

Funding

Adeno-associated Virus Biology And Utilization For Gene TransferZIADE000695 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI CHIORINI, JAY · 2009 to 2025
$36.6M
Clinical Investigations of Sjogren's SyndromeZIADE000704 · NIDCR · NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH · PI WARNER, BLAKE · 2009 to 2025
$22.3M
Intramural NIH HHS Z99 DE999999Intramural NIH HHS ZIA DE000704
6 · The paper itself

Abstract

objectivesThe purpose of this study was to examine the humoral and cellular immune reactivity to adenoviral vector (AdhAQP1) administration in the human parotid gland over the first 42 days of a clinical gene therapy trial.

methodsOf eleven treated subjects, five were considered as positive responders (Baum et al, 2012). Herein, we measured serum neutralizing antibody titers, circulating cytotoxic lymphocytes, and lymphocyte proliferation in peripheral blood mononuclear cells. Additionally, after adenoviral vector stimulation of lymphocyte proliferation, we quantified secreted cytokine levels.

resultsResponders showed little to modest immune reactivity during the first 42 days following gene transfer. Additionally, baseline serum neutralizing antibody titers to serotype 5-adenovirus generally were not predictive of a subject's response to parotid gland administration of AdhAQP1. Cytokine profiling from activated peripheral blood mononuclear cells could not distinguish responders and non-responders.

conclusionsThe data are the first to describe immune responses after adenoviral vector administration in a human parotid gland. Importantly, we found that modest (2-3 fold) changes in systemic cell-mediated immune reactivity did not preclude positive subject responses to gene transfer. However, changes beyond that level likely impeded the efficacy of gene transfer.

Indexed as

T-Lymphocytes, CytotoxicAdenoviridaeAgedAntibodies, NeutralizingAquaporin 1Cell ProliferationCytokinesDNA, ComplementaryFemaleGenetic TherapyGenetic VectorsHumansImmunity, CellularLymphocyte CountMaleMiddle AgedAntibodies, NeutralizingAQP1 protein, humanAquaporin 1CytokinesDNA, Complementaryadenoviralgene transferimmune reactivityparotid

Identifiers

PMID27886428
PMCPMC5340570
OpenAlexW2554915101

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.