Dataset Information

Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.

ABSTRACT: An 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 The individual component(s) responsible for paralysis were not identified, and the vaccine was withdrawn.Subjects participating in two contemporaneous non-randomized Phase 1 clinical trials of nasal subunit vaccines against Human Immunodeficiency Virus and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.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.

SUBMITTER: Lewis DJ

PROVIDER: S-EPMC2737308 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.

Lewis David J M DJ Huo Zhiming Z Barnett Susan S Kromann Ingrid I Giemza Rafaela R Galiza Eva E Woodrow Maria M Thierry-Carstensen Birgit B Andersen Peter P Novicki Deborah D Del Giudice Giuseppe G Rappuoli Rino R

PloS one 20090916 9

<h4>Background</h4>An 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 The individual component(s) responsible for paralysis were not identified, and the vaccine was withdrawn.<h4>Methodology/principal findings</h4>Subjects participating in two contemporaneous non-randomized Phase 1 clinical trials of n ...[more]

PMID: 19756141

Similar Datasets

Project description:Current recommendations envisage early surgical exploration for complete facial nerve paralysis associated with temporal bone fracture and unfavorable electrophysiologic features (response to electroneuronography, <5%). However, the evidence base for such a practice is weak, with the potential for spontaneous improvement being unknown, and the expected results from alternative nonsurgical treatment also undefined.To document the results of nonsurgical treatment for posttraumatic complete facial paralysis with undisplaced temporal bone fracture and unfavorable electrophysiologic features.Prospective cohort study recruiting from April 2010 to April 2013 at a tertiary care university hospital. Follow-up continued until 9 months or until complete recovery if earlier. Study group included 28 patients with head injury-associated complete unilateral facial nerve paralysis with unfavorable results of electroneuronography (<5% response) with or without undisplaced temporal bone fracture. Undisplaced temporal bone fractures were documented in 26 patients (24 longitudinal fractures and 2 transverse fractures).Patients received prednisolone, 1 mg/kg, for 3 weeks combined with clinical monitoring every 2 weeks and electromyography monitoring every 4 weeks. As per study protocol, surgical exploration was limited to patients demonstrating motor end plate degeneration on results of electromyography, or having no improvement until 18 weeks.Facial nerve function was evaluated by the House-Brackmann grading system; Forehead, Eye, Mouth, and Associated defect grading system; and the modified Adour system. Observations were completed at 40 weeks.Among the 28 patients in the study (3 women and 25 men; mean [SD] age, 32.2 [8.7] years), facial nerve recovery with conservative treatment alone was noted in all patients. No recovery was seen in any patient at the initial 4-week review. The first signs of clinical recovery were noted in 4 patients by 8 weeks, in 27 patients by 12 weeks, and in all patients by 20 weeks. No patient required surgical exploration. At 40 weeks, 27 patients recovered to House-Brackmann grade I/II and 1 patient to grade III. All 24 patients with longitudinal fractures had grade I/II recovery.For undisplaced temporal bone fractures, nonsurgical treatment leads to near-universal recovery to House-Brackmann grade I/II and is superior to reported surgical results. Recovery is delayed and usually first manifests at 8 to 12 weeks after the fracture. In the current era of high-resolution computed tomography, surgical exploration should not be first-line treatment for undisplaced longitudingal temporal bone fractures associated with complete facial nerve paralysis and unfavorable electrophysiologic features.

Project description:Importance:A review of the role of masseteric nerve transfer is needed to guide its use in facial reanimation. Objective:To systematically review the available literature, and, when applicable, analyze the combined outcomes of masseteric nerve transfer to better define its role in reanimation and to guide further research. Data Sources:Two independent researchers conducted the review using PubMed-NCBI and Scopus literature databases for studies on masseteric nerve transfer for facial nerve paralysis. Study Selection:Studies that examined masseter nerve transfer with additional cranial nerve transposition/coaptation or muscle flap were excluded. Data Extraction and Synthesis:Literature review and data extraction followed established PRISMA guidelines. Two researchers extracted data independently. Main Outcomes and Measures:The main planned outcomes for the study were quantitative results of facial nerve movement after nerve transfer including oral commissure movement and time to nerve recovery. Results:A total of 13 articles met inclusion criteria with a total of 183 patients undergoing masseteric nerve transfer. From those studies, there were a total of 183 patients who underwent masseteric nerve transfer. There were 85 men and 98 women with a mean (SD) age of 43 (12.2) years and mean (SD) follow up examination after surgery of 22 (7.6) months. Mean (SD) duration of nerve paralysis was 14 (6) months. Most common cause of paralysis was cerebellopontine angle tumors (81%). Six studies coapted the masseteric nerve to the main facial nerve trunk, whereas 7 used distal branches (buccal or zygomatic). Four studies used interposition nerve grafts with great auricular nerve. Two measures, improvement in oral commissure excursion and length from reanimation to facial movement, were measured consistently across the studies. Pooled analysis showed time from surgery to first facial movement, described in 10 studies, to be 4.95 months (95% CI, 3.66 to 6.24). Distal branch coaptation improved time to recovery vs main branch coaptation, 3.76 vs 5.76 months (95% CI, -0.33 to 4.32), but mean difference was not significant. The use of interposition graft significantly delayed time of nerve recovery, 6.24 vs 4.06 months (95% CI, 0.20 to 4.16). When controlled for main trunk coaptation only, interposition nerve graft delayed recovery but difference was no longer statistically significant, 6.24 vs 4.75 months (95% CI, -0.94 to 3.92). Reported complications were minor and rare occurring in only 6.5% (12 of 183) of patients. Conclusions and Relevance:The masseteric nerve was found to be a good option for nerve transfer in this patient population, and showed favorable results in both time to nerve recovery and improvement in oral commissure excursion. Level of Evidence:NA.

Dataset Information

Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.

Publications

Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets