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NCT04665791
A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults
NA trial testing Intranasal inoculation with Neisseria lactamica in Meningitis, Meningococcal in 55 participants. Completed in 6 June 2023.
10 October 2021
Quick facts
| Lead sponsor | Center for Vaccine Development - Mali |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 55 |
| Start date | 2 March 2021 |
| Primary completion | 10 October 2021 |
| Estimated completion | 6 June 2023 |
| Sites | 1 location across Mali |
Drugs / interventions tested
- Intranasal inoculation with Neisseria lactamica — full drug profile →
Conditions studied
- Meningitis, Meningococcal — all drugs for Meningitis, Meningococcal →
Sponsor
Center for Vaccine Development - Mali — full company profile →
Who can join
Adults 18 to 45, any sex, with Meningitis, Meningococcal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Advances in intranasal vaccine delivery: A promising non-invasive route of immunization.
Kehagia E, Papakyriakopoulou P, Valsami G. · · 2023 · cited 69× · PMID 37179163 · DOI 10.1016/j.vaccine.2023.05.011 -
Controlled Human Infection of Healthy Adults With Lyophilized <i>Neisseria lactamica</i> Induces Asymptomatic, Immunogenic Nasopharyngeal Carriage in the United Kingdom and Mali.
Gbesemete DF, Haidara F, Laver JR, Ibrahim M, et al · · 2026 · PMID 41574175 · DOI 10.1093/ofid/ofaf809
Verify or expand the search:
- PubMed search for NCT04665791
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Meningitis, Meningococcal
Currently open trials in the same condition.
- NCT06113198 — A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants · Phase 4 · active not recruiting
- NCT05087056 — Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04665791 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Center for Vaccine Development - Mali
- Last refreshed: 27 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04665791.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing