Status:
COMPLETED
A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults
Lead Sponsor:
Center for Vaccine Development - Mali
Collaborating Sponsors:
University of Southampton
University of Maryland
Conditions:
Meningitis, Meningococcal
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief 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...
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 st...
Eligibility Criteria
Inclusion
- Healthy adults aged 18 to 45 years inclusive on the day of enrolment residing outside the demographic surveillance area
- Able and willing (in the investigator's opinion) to understand and comply with all study requirements including availability for all study follow up visits
- Provide written informed consent to participate in the trial
- For females only, all the following:
- willingness to practice continuous effective contraception at least until the Day 28 visit is complete
- negative urine pregnancy test on the screening day
- negative urine pregnancy test on inoculation day
Exclusion
- Eligibility Minimum Age: 18 Years Maximum Age: 45 Years Sex: All Gender Based: No Accepts Healthy Volunteers: Yes
- Criteria: Inclusion Criteria:
- Healthy adults aged 18 to 45 years inclusive on the day of enrolment residing outside the demographic surveillance area
- Able and willing (in the investigator's opinion) to understand and comply with all study requirements including availability for all study follow up visits
- Provide written informed consent to participate in the trial
- For females only, all the following:
- willingness to practice continuous effective contraception at least until the Day 28 visit is complete
- negative urine pregnancy test on the screening day
- negative urine pregnancy test on inoculation day
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04665791
Start Date
March 2 2021
End Date
June 6 2023
Last Update
March 27 2025
Active Locations (1)
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1
CVD Mali
Bamako, Mali