ArticlePloS one2009
Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.
Article in PloS one, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 158 papers.
What it found
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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.
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Who cites it
158 citing papers in PubMed, 294 citations in OpenAlex.
- An intranasal adjuvanted, recombinant influenza A/H5 vaccine primes against diverse H5N1 clades: a phase I trial.Nature communications · 2025Trial
- Safety, tolerability, and efficacy of intranasally-administered detoxified LTh(αK) in mild-to-moderate COVID-19 patients: A randomized, double-blinded, placebo-controlled phase 2 study.Human vaccines & immunotherapeutics · 2024Trial
- Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial.American journal of respiratory and critical care medicine · 2019Trial
- Systemic and mucosal immune responses to sublingual or intramuscular human papilloma virus antigens in healthy female volunteers.PloS one · 2012Trial
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- Immunogenicity and protective potential of a mucosal protein-only vaccine candidate for tuberculosis.Frontiers in immunology · 2026Article
- Adjuvant Strategies to Improve the Efficacy of Allergen Immunotherapy.Journal of inflammation research · 2026Review
- Next-generation intranasal influenza vaccines: mechanisms, platforms, and translational progress.Frontiers in immunology · 2026Review
- rBCG-LTAK63 Outperforms BCG in Bladder Cancer Immunotherapy: Dendritic and T Cell Coordination Drives Superior Tumor Control in a Mouse Model.International journal of biological sciences · 2026Article
- Engineering a medical device for intranasal immunisation: ensuring targeted delivery and formulation stability.Frontiers in drug delivery · 2026Article
- Respiratory immunization using antibiotic-inactivated Bordetella pertussis confers T cell-mediated protection against nasal infection in mice.Nature microbiology · 2025Article
- Conserved CD8 T cell vaccines without B cell epitopes drive robust protection against SARS-CoV-2 that is enhanced by intranasal boost.Science advances · 2025Article
- Nasal immunization with compound 48/80-adjuvanted acellular pertussis vaccines is an effective strategy to induce pertussis-specific systemic and mucosal immunity.Clinical and experimental vaccine research · 2025Article
- A VCG-Based MultiepitopeBiomedicines · 2025Article
- rBCG-LTAK63 enhances protection against tuberculosis by inducing autophagy and circadian gene regulation.Frontiers in immunology · 2025Article
- Distinct humoral responses induced by heterologous versus homologous prime-boost immunization strategies in early life.Frontiers in immunology · 2025Article
98 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 3 countries.
Funding
Abstract
backgroundAn association was previously established between facial nerve paralysis (Bell's palsy) and intranasal administration of an inactivated influenza virosome vaccine containing an enzymatically active Escherichia coli Heat Labile Toxin (LT) adjuvant. The individual component(s) responsible for paralysis were not identified, and the vaccine was withdrawn. METHODOLOGY/PRINCIPAL
findingsSubjects participating in two contemporaneous non-randomized Phase 1 clinical trials of nasal subunit vaccines against Human Immunodeficiency Virus and tuberculosis, both of which employed an enzymatically inactive non-toxic mutant LT adjuvant (LTK63), underwent active follow-up for adverse events using diary-cards and clinical examination. Two healthy subjects experienced transient peripheral facial nerve palsies 44 and 60 days after passive nasal instillation of LTK63, possibly a result of retrograde axonal transport after neuronal ganglioside binding or an inflammatory immune response, but without exaggerated immune responses to LTK63. CONCLUSIONS/SIGNIFICANCE: While the unique anatomical predisposition of the facial nerve to compression suggests nasal delivery of neuronal-binding LT-derived adjuvants is inadvisable, their continued investigation as topical or mucosal adjuvants and antigens appears warranted on the basis of longstanding safety via oral, percutaneous, and other mucosal routes.
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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.