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A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults

NCT04665791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-03-27

No results posted yet for this study

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.

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

Intranasal inoculation with Neisseria lactamica

Lyophilised Neisseria lactamica will be reconstituted and administered to participants intranasally.

Sponsors & Collaborators

  • University of Southampton

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Public Health England

    collaborator OTHER_GOV

  • Center for Vaccine Development - Mali

    lead OTHER

Principal Investigators

  • Robert C Read, MD FRCP · University of Southampton

  • Samba Sow, MD · Center for Vaccine Development - Mali

  • Milagritos Tapia, MD · University of Maryland

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-10-10
Completion
2023-06-06

Countries

  • Mali

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665791 on ClinicalTrials.gov