Meningitis, MeningococcalNCT04665791
A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults
A study testing Intranasal inoculation with Neisseria lactamica in people with Meningitis, Meningococcal, run by Center for Vaccine Development - Mali at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Intranasal inoculation with Neisseria lactamica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteMali
- Study dates
- 2 Mar 2021to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 21Show fewer
- 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
- N. lactamica detected on throat swab taken at the screening visit
- Individuals who have an ongoing acute illness at the time of inoculation
- Individuals who have been involved in other clinical trials involving receipt of an investigational product over the last 12 weeks or if there is planned use of an investigational product during the study period
- Use of systemic antibiotics within the period 30 days prior to the challenge
- Any confirmed or suspected immunosuppressive or immune-deficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication (including oral steroids) within the past 6 months (topical steroids are allowed)
- Use of immunoglobulins or blood products within 3 months prior to enrolment.
- History of allergic disease or reactions to soya.
- Any clinically significant abnormal finding on clinical examination or screening investigations
- History of any surgery to the nose or throat in the previous 3 months
- Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Occupational, household or intimate contact with immunosuppressed persons
- Positive pregnancy test or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the 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
- Being tested
- Intranasal inoculation with Neisseria lactamica
- Keywords
- Meningitis, Controlled human infection, Healthy volunteer, Neisseria lactamica, Lyophilization
- Medical subject headings
- Meningitis, Meningococcal, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal inoculation with Neisseria lactamicaBiological
Lyophilised Neisseria lactamica will be reconstituted and administered to participants intranasally.
| Study group | Role | What they receive |
|---|---|---|
| Challenge | Experimental | Challenge participants will be inoculated intranasally with reconstituted, previously lyophilised Neisseria lactamica (LyoNlac). The initial dose will be 10^5 colony forming units and will be escalated to a maximum of 10^7 colony forming units to find the dose which successfully colonises at least 70% of volunteers. Receives: Biological: Intranasal inoculation with Neisseria lactamica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the impact of nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by assessing nasopharyngeal colonisation with Neisseria species
Throat swabs will be taken at standardised visits and analysed for nasopharyngeal colonisation with Neisseria species. Standard tests include culture and polymerase chain reaction (PCR)
Measured: 6 months
Establish the effect of the nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by collecting information about symptoms
Information about symptoms will be collected at standardised visits. Any symptoms will be recorded and assessed by a study doctor. If deemed necessary by the study doctor further tests will be requested.
Measured: 6 months
Analyse the haemoglobin of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - haemoglobin - g/dL
Measured: 3 months
Analyse the white cell count of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - white cell count - x 10^9/L
Measured: 3 months
Analyse the platelet count of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - Platelet count x 10^9/L
Measured: 3 months
Analyse the biochemistry blood results (ALT) of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - ALT
Measured: 3 months
Analyse the biochemistry blood results (Creatinine) of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - Creatinine (mg/dL)
Measured: 3 months
Secondary outcomes (2)
The dose of reconstituted lyophilised Neisseria lactamica required for nasopharyngeal colonisation in at least 70% of inoculees
The dose will be confirmed by throat swabs taken from participants and analysed for bacteria by culture and polymerase chain reaction. The desired dose will be confirmed when at least 70%o of inoculees are colonised
Measured: 6 months
To measure Neisseria lactamica specific immunity following nasal inoculation with reconstituted lyophilised Neisseria lactamica
Blood samples will be collected at standardised visits and antibody levels (mg/dL) will be measured to assess if those colonised with Neisseria lactamica show an increase in antibody levels in comparison to baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start2 Mar 2021
- Primary completion10 Oct 2021
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, MeningococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective dose-ranging human challenge study. Nasal inoculation with reconstituted, previously lyophilised Neisseria lactamica with dose escalation.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Vaccine Development - Mali
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, University of Maryland, University College, London, University of Oxford, Public Health England
- Responsible party
- Sponsor
- Investigators
- Robert C Read, MD FRCP, Principal investigator, University of SouthamptonSamba Sow, MD, Principal investigator, Center for Vaccine Development - MaliMilagritos Tapia, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665791
- Sponsor's protocol ID
- 62190
- Status last verified
- Mar 2025
- First submitted
- 7 Dec 2020
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gbesemete DF, Haidara F, Laver JR, Ibrahim M, MacLennan J, Dale AP, Gorringe AR, Traore Y, Diallo F, Badji H, Traore A, Onwuchekwa U, Jones E, Webb C, Guy J, Theodosiou AA, Faust SN, Sow SO, Heyderman RS, Tapia MD, Read RC. Controlled Human Infection of Healthy Adults With Lyophilized Neisseria lactamica Induces Asymptomatic, Immunogenic Nasopharyngeal Carriage in the United Kingdom and Mali. Open Forum Infect Dis. 2026 Jan 7;13(1):ofaf809. doi: 10.1093/ofid/ofaf809. eCollection 2026 Jan.
PubMed 41574175
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04665791
- Acronym / sponsor ID
- 62190
- Conditions
- Meningitis, Meningococcal
- Keywords
- Meningitis, Controlled human infection, Healthy volunteer, Neisseria lactamica, Lyophilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Center for Vaccine Development - MaliUniversity, hospital or other
- Collaborators
- University of Southampton, University of Maryland, University College, London, University of Oxford, Public Health England
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective dose-ranging human challenge study. Nasal inoculation with reconstituted, previously lyophilised Neisseria lactamica with dose escalation.
| Arm | Type | Receives |
|---|---|---|
| Challenge | Experimental | Biological: Intranasal inoculation with Neisseria lactamicaChallenge participants will be inoculated intranasally with reconstituted, previously lyophilised Neisseria lactamica (LyoNlac). The initial dose will be 10^5 colony forming units and will be escalated to a maximum of 10^7 colony forming units to find the dose which successfully colonises at least 70% of volunteers. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- Eligibility Minimum Age: 18 Years Maximum Age: 45 Years Sex: All Gender Based: No Accepts Healthy Volunteers: Yes
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal inoculation with Neisseria lactamicaLyophilised Neisseria lactamica will be reconstituted and administered to participants intranasally. | Biological | Challenge |
Primary outcome
Establish the impact of nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by assessing nasopharyngeal colonisation with Neisseria species
Time frame: 6 months
Throat swabs will be taken at standardised visits and analysed for nasopharyngeal colonisation with Neisseria species. Standard tests include culture and polymerase chain reaction (PCR)
Establish the effect of the nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by collecting information about symptoms
Time frame: 6 months
Information about symptoms will be collected at standardised visits. Any symptoms will be recorded and assessed by a study doctor. If deemed necessary by the study doctor further tests will be requested.
Analyse the haemoglobin of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Time frame: 3 months
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - haemoglobin - g/dL
Analyse the white cell count of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Time frame: 3 months
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - white cell count - x 10^9/L
Analyse the platelet count of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Time frame: 3 months
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - Platelet count x 10^9/L
Analyse the biochemistry blood results (ALT) of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Time frame: 3 months
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - ALT
Analyse the biochemistry blood results (Creatinine) of healthy Malian volunteers inoculated with reconstituted lyophilised Neisseria lactamica
Time frame: 3 months
Blood samples will be taken at specified time points and compared to those collected at baseline. Any change in results will be recorded and, if deemed necessary by the medical team, further tests will be requested. Standard tests - Creatinine (mg/dL)
2 secondary outcomes
The dose of reconstituted lyophilised Neisseria lactamica required for nasopharyngeal colonisation in at least 70% of inoculees
Time frame: 6 months
To measure Neisseria lactamica specific immunity following nasal inoculation with reconstituted lyophilised Neisseria lactamica
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Derived from this study: PubMed 41574175Gbesemete DF, Haidara F, Laver JR, Ibrahim M, MacLennan J, Dale AP, Gorringe AR, Traore Y, Diallo F, Badji H, Traore A, Onwuchekwa U, Jones E, Webb C, Guy J, Theodosiou AA, Faust SN, Sow SO, Heyderman RS, Tapia MD, Read RC. Controlled Human Infection of Healthy Adults With Lyophilized Neisseria lactamica Induces Asymptomatic, Immunogenic Nasopharyngeal Carriage in the United Kingdom and Mali. Open Forum Infect Dis. 2026 Jan 7;13(1):ofaf809. doi: 10.1093/ofid/ofaf809. eCollection 2026 Jan.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Read, MD FRCP principal investigator
University of Southampton
Samba Sow, MD principal investigator
Center for Vaccine Development - Mali
Milagritos Tapia, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal inoculation with Neisseria lactamica in people with Meningitis, Meningococcal, run by Center for Vaccine Development - Mali at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the impact of nasal inoculation of healthy Malian volunteers with reconstituted lyophilised Neisseria lactamica by assessing nasopharyngeal colonisation with Neisseria species (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04665791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.