A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults (NCT04665791) | Clinical Trial Compass
CompletedNot Applicable
A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults
Mali55 participantsStarted 2021-03-02
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion Criteria:
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
Exclusion Criteria:
* N. lactamica detected on throat swab taken at the screening visit
* Individuals who have an ongoing acute…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish the impact of nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by assessing nasopharyngeal colonisation with Neisseria species
Timeframe: 6 months
2
Establish the effect of the nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by collecting information about symptoms
Timeframe: 6 months
3
Analyse the haemoglobin of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Timeframe: 3 months
4
Analyse the white cell count of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Timeframe: 3 months
5
Analyse the platelet count of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Timeframe: 3 months
6
Analyse the biochemistry blood results (ALT) of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica