NCT04665791

A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults

A Human Controlled Infection Study to Assess Colonisation and Immunogenicity Following Nasal Inoculation of Malian Adults with Reconstituted Lyophilised Wild Type Neisseria Lactamica (Lactamica Etape 1)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Center for Vaccine Development - Mali · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is part of a series of projects to improve protection against meningitis. Previously, researchers have given nose drops containing N. lactamica to over 400 volunteers and shown that many of them become colonised with N. lactamica without causing any illness or disease. This has previously been shown to prevent people from becoming colonised with N. meningitidis which can cause meningitis. This study aims to give nose drops containing N. lactamica to healthy adults in Mali, to see if they become safely colonised. In the future the study team would like to find out how N.lactamica helps children resist N.meningitidis, and develop new vaccines that exploit that mechanism.

Detailed description

In this pilot research, the study team will use a methodology of nasal inoculation with reconstituted lyophilised N. lactamica (hereafter LyoNlac) developed in a previous, UK-based, human challenge study. This methodology and will be developed further and validated in healthy Malian adults. A dose-ranging strategy will be used, starting with the dose identified as the standard inoculum in healthy adults in the UK, which was the dose required to induce colonisation in approximately 80% of volunteers. The dose will be escalated to a dose able to induce a similar level of colonisation in Malian adults. This study will inform the study team whether intranasal inoculation of reconstituted lyophilised Nlac (hereafter, lyoNlac), can result in immunising colonisation of adult Malian volunteers and the optimal dose to achieve this. This dose and methodology will then be used in future studies looking at the duration and immunogenicity of colonisation induced by LyoNlac in Mali.

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Intranasal inoculation with Neisseria lactamica	Lyophilised Neisseria lactamica will be reconstituted and administered to participants intranasally.

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-10-10
• Completion: 2023-06-06
• First posted: 2020-12-14
• Last updated: 2025-03-27

Locations

1 site across 1 country: Mali