Evidence map›Paper›PMID 12540551›Full record

ArticleInfection and immunity2003

Protective levels of diphtheria-neutralizing antibody induced in healthy volunteers by unilateral priming-boosting intranasal immunization associated with restricted ipsilateral mucosal secretory immunoglobulin a.

Kingston H G Mills, Catherine Cosgrove, Edel A McNeela, Amy Sexton, Rafaela Giemza, Inderjit Jabbal-Gill, Anne Church, Wu Lin, Lisbeth Illum, Audino Podda and 4 more

Open access · greenAbstract read
In one paragraph

Article in Infection and immunity, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
5.3field-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.

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

35 citing papers in PubMed, 101 citations in OpenAlex.

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  16. Intranasal immunization with aluminum salt-adjuvanted dry powder vaccine.Journal of controlled release : official journal of the Controlled Release Society · 2018
    Article
  17. Intranasal immunization with dry powder vaccines.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2018
    Review
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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

14 authors at 3 institutions in 2 countries.

Kingston H G MillsImmune Regulation Research Group, Department of Biochemistry, Trinity College, Dublin 2, Ireland.
Catherine Cosgrove
Edel A McNeela
Amy Sexton
Rafaela Giemza
Inderjit Jabbal-Gill
Anne Church
Wu Lin
Lisbeth Illum
Audino Podda
Rino Rappuoli
Mariagrazia Pizza
George E Griffin
David J M Lewis
St George's, University of London · GBWest Pharmaceutical Services (United Kingdom) · GBTrinity College Dublin · IE

Funding

Wellcome Trust
6 · The paper itself

Abstract

Subunit intranasal vaccines offer the prospect of inducing combined systemic-mucosal immunity against mucosally transmitted infections such as human immunodeficiency virus. However, although human studies have demonstrated the induction of active immunity, secretory immunoglobulin A (sIgA) responses are variable, and no study has demonstrated protection by accepted vaccine-licensing criteria as measured by direct toxin-neutralizing activity. Using the genetically inactivated mutant diphtheria toxoid CRM(197) in a bioadhesive polycationic polysaccharide chitosan delivery system, we found that a single nasal immunization was well tolerated and boosted antitoxin neutralizing activity in healthy volunteers, which could be further boosted by a second immunization. The neutralizing activity far exceeded accepted protective levels and was equivalent to that induced by standard intramuscular vaccine and significantly greater than intranasal immunization with CRM(197) in the absence of chitosan. A striking but unexpected observation was that although unilateral intranasal immunization induced circulating antitoxin antibody-secreting cells, a nasal antitoxin sIgA response was seen only after the second immunization and only in the vaccinated nostril. If these data are reproduced in larger studies, an intranasal diphtheria vaccine based on CRM(197)-chitosan could be rapidly licensed for human use. However, a restricted sIgA response suggests that care must be taken in the priming-boosting strategy and clinical sampling techniques when evaluating such vaccines for the induction of local mucosal immunity.

Indexed as

Administration, IntranasalAdultAntibodies, BacterialBacterial ProteinsChitinChitosanCorynebacterium diphtheriaeDiphtheriaDiphtheria ToxinDiphtheria ToxoidDrug Delivery SystemsFemaleHumansImmunity, MucosalImmunization, SecondaryImmunoglobulin A, SecretoryAntibodies, BacterialBacterial ProteinsChitinChitosanCRM197 (non-toxic variant of diphtheria toxin)Diphtheria ToxinDiphtheria ToxoidImmunoglobulin A, Secretory

Identifiers

PMID12540551
PMCPMC145378
OpenAlexW2142041681

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.