Controlled Human Infection of Healthy Adults With Lyophilized Neisseria lactamica Induces Asymptomatic, Immunogenic Nasopharyngeal Carriage in the United Kingdom and Mali - Scorecard - MDSpire
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Controlled Human Infection of Healthy Adults With Lyophilized Neisseria lactamica Induces Asymptomatic, Immunogenic Nasopharyngeal Carriage in the United Kingdom and Mali
Clinical Scorecard: Induction of Asymptomatic Nasopharyngeal Carriage and Immune Response Following Controlled Infection with Lyophilized Neisseria lactamica in Healthy Adults in the UK and Mali
At a Glance
Category
Detail
Condition
Asymptomatic nasopharyngeal colonization with Neisseria lactamica to reduce Neisseria meningitidis carriage
Key Mechanisms
Intranasal inoculation with lyophilized N. lactamica induces colonization and cross-reactive immune responses that may inhibit N. meningitidis acquisition
Target Population
Healthy adults aged 18–45 years in the UK and Mali
Care Setting
Controlled human infection studies and potential use in community outbreak settings in sub-Saharan Africa
Key Highlights
Intranasal inoculation with lyophilized N. lactamica (LyoNlac) is safe and well tolerated with no significant adverse events.
Dose-dependent colonization achieved: 100% colonization at 10^5 CFU in UK adults, 65% colonization at 10^7 CFU in Malian adults.
Colonization induces significant increases in N. lactamica- and N. meningitidis-specific IgG antibodies in colonized participants.
Guideline-Based Recommendations
Diagnosis
Diagnosis of colonization is based on detection of N. lactamica in nasopharyngeal samples post-inoculation.
Management
Intranasal administration of lyophilized N. lactamica can be considered for inducing asymptomatic colonization to potentially reduce meningococcal carriage.
Use of lyophilized formulation allows deployment without cold chain, facilitating use in resource-limited settings.
Monitoring & Follow-up
Monitor colonization status and serological responses post-inoculation to assess immune response and colonization kinetics.
Observe for any adverse events or safety concerns following inoculation.
Risks
No significant safety concerns identified in controlled human infection studies with over 350 volunteers inoculated.
Rare association of N. lactamica with disease; considered a harmless commensal.
Patient & Prescribing Data
Healthy adult volunteers aged 18–45 years in UK and Mali
Lyophilized N. lactamica administered intranasally induces colonization and cross-reactive immunity, with colonization rates varying by dose and population.
Clinical Best Practices
Use lyophilized N. lactamica strain Y92-1009 for intranasal inoculation to induce colonization safely.
Select inoculum dose based on target population to achieve ≥70% colonization (e.g., 10^5 CFU in UK adults).
Consider monitoring IgG antibody responses to both N. lactamica and N. meningitidis as markers of immunogenicity.
Plan future clinical trials to evaluate efficacy in reducing meningococcal carriage and transmission in meningitis belt regions.
by D F Gbesemete, F Haidara, J R Laver, M Ibrahim, J MacLennan, A P Dale, A R Gorringe, Y Traore, F Diallo, H Badji, A Traore, U Onwuchekwa, E Jones, C Webb, J Guy, A A Theodosiou, S N Faust, S O Sow, R S Heyderman, M D Tapia, R C Read
