Evidence map›Paper›PMID 27629482›Full record

ArticleHuman vaccines & immunotherapeutics2017

Evaluation of the potential effects of AS03-adjuvanted A(H1N1)pdm09 vaccine administration on the central nervous system of non-primed and A(H1N1)pdm09-primed cotton rats.

Camille Planty, Corey P Mallett, Kevin Yim, Jorge C G Blanco, Marina Boukhvalova, Thomas March, Robbert van der Most, Eric Destexhe

Open access · bronzeAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.7field-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.

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

6 citing papers in PubMed, 10 citations in OpenAlex.

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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

8 authors at 2 institutions in 2 countries.

Camille Plantya GSK Vaccines , Rixensart , Belgium.
Corey P Mallettb GSK Vaccines , Laval , QC , Canada.
Kevin Yimc Sigmovir Biosystems Inc. , Rockville , MD , USA.
Jorge C G Blancoc Sigmovir Biosystems Inc. , Rockville , MD , USA.
Marina Boukhvalovac Sigmovir Biosystems Inc. , Rockville , MD , USA.
Thomas Marchd DBA Thomas H. March , Albuquerque , NM , USA.
Robbert van der Mosta GSK Vaccines , Rixensart , Belgium.
Eric Destexhea GSK Vaccines , Rixensart , Belgium.
GlaxoSmithKline (Belgium) · BESigmovir Biosystems (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An increased risk of narcolepsy following administration of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine (Pandemrix™) was described in children and adolescents in certain European countries. We investigated the potential effects of administration of the AS03-adjuvanted vaccine, non-adjuvanted vaccine antigen and AS03 Adjuvant System alone, on the central nervous system (CNS) in one-month-old cotton rats. Naïve or A(H1N1)pdm09 virus-primed animals received 2 or 3 intramuscular injections, respectively, of test article or saline at 2-week intervals. Parameters related to systemic inflammation (hematology, serum IL-6/IFN-γ/TNF-α) were assessed. Potential effects on the CNS were investigated by histopathological evaluation of brain sections stained with hematoxylin-and-eosin, or by immunohistochemical staining of microglia, using Iba1 and CD68 as markers for microglia identification/activation, albumin as indicator of vascular leakage, and hypocretin. We also determined cerebrospinal fluid (CSF) hypocretin levels and hemagglutination-inhibiting antibody titers. Immunogenicity of the AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine was confirmed by the induction of hemagglutination-inhibiting antibodies. Both AS03-adjuvanted vaccine and AS03 alone activated transient innate (neutrophils/eosinophils) immune responses. No serum cytokines were detected. CNS analyses revealed neither microglia activation nor inflammatory cellular infiltrates in the brain. No differences between treatment groups were detected for albumin extravascular leakage, CSF hypocretin levels, numbers of hypocretin-positive neuronal bodies or distributions of hypocretin-positive axonal/dendritic projections. Consequently, there was no evidence that intramuscular administration of the test articles promoted inflammation or damage in the CNS, or blood-brain barrier disruption, in this model.

Indexed as

AnimalsAntibodies, ViralBrainDrug CombinationsHemagglutination Inhibition TestsHistocytochemistryImmunohistochemistryInfluenza A Virus, H1N1 SubtypeInfluenza VaccinesInjections, IntramuscularLipid AOrexinsSaponinsSigmodontinaeAntibodies, ViralASO2A adjuvantDrug CombinationsInfluenza VaccinesLipid AOrexinsSaponinsA(H1N1)pdm09AS03cotton ratnarcolepsypandemic influenza vaccinePandemrix

Identifiers

PMID27629482
PMCPMC5287305
OpenAlexW2520818596

What OpenQuestion holds

Textmetadata
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.