NCT03633474 (Lac-7) is a EARLY_PHASE1 clinical trial of N. lactamica in Meningitis, Bacterial, sponsored by University of Southampton.

Who is sponsoring NCT03633474?

NCT03633474 is sponsored by University of Southampton.

What drugs are being tested in NCT03633474?

Interventions in NCT03633474: N. lactamica, PBS only.

What condition does NCT03633474 study?

NCT03633474 studies Meningitis, Bacterial.

Is NCT03633474 still recruiting?

NCT03633474 is currently completed. Last updated 22 October 2019.

Last reviewed 2019-10-22 · How we verify

NCT03633474: Lac-7

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Defining the Immune Response to Nasopharyngeal Colonisation by the Commensal Neisseria Lactamica

Completed EARLY_PHASE1 Last updated 22 October 2019

What this trial tests

EARLY_PHASE1 trial testing N. lactamica in Meningitis, Bacterial in 31 participants. Completed in 1 September 2019.

Timeline

1 September 2018

Primary endpoint
1 September 2019

1 September 2019

Quick facts

Lead sponsor	University of Southampton
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	31
Start date	1 September 2018
Primary completion	1 September 2019
Estimated completion	1 September 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

N. lactamica — full drug profile →
PBS only

Conditions studied

Meningitis, Bacterial — all drugs for Meningitis, Bacterial →

Sponsor

University of Southampton

Who can join

Adults 18 to 45, any sex, with Meningitis, Bacterial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neisseria meningitidis is a 'bad bacteria' which lives harmlessly in the nose and throat of many young adults (a process called colonisation). However, it can occasionally cause serious disease including meningitis. Vaccines have proven effective in preventing disease associated with a number of strains of this bacterium, however some disease-causing strains are not covered by currently available vaccines. This research is focused on exploring new approaches to preventing colonisation and disease caused by this bacterium. Neisseria lactamica is a 'good bacteria' that colonises the nose and throat of young children. It does not cause disease in healthy people. In a previous study it has been demonstrated that the introduction of Neisseria lactamica into the noses of healthy adult volunteers resulted in a significant decrease in Neisseria meningitidis colonisation. However, it is not yet understood why this effect occurs. One theory is that the immune response the body mounts in response to colonisation with the 'good bacteria' cross-reacts with the 'bad bacteria' and in so doing eradicates the bad bacteria from the nose and throat. This study aims to outline the nature of the immune responses mounted in response to colonisation with the good bacteria, N. lactamica, after introducing it into the noses of healthy adult volunteers. In addition, the study aims to establish how the introduction of the good bacteria changes the other bacterial populations that live in the nose and throat.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of colonisation with Neisseria lactamica on cross-reactive anti-meningococcal B-cell responses: a randomised, controlled, human infection trial.
Dale AP, Theodosiou AA, Gbesemete DF, Guy JM, et al · · 2022 · cited 12× · PMID 36462524 · DOI 10.1016/s2666-5247(22)00283-x

Verify or expand the search:

Other trials of N. lactamica

Trials testing the same drug.

NCT03630250 — Challenge of the Nasopharynx With Neisseria Lactamica Expressing the Meningococcal Protein Neisseria Adhesin A (NadA) · EARLY_PHASE1 · completed

Other recruiting trials for Meningitis, Bacterial

Currently open trials in the same condition.

NCT07134751 — Febrile Infants Swedish Study · recruiting

Other University of Southampton trials

Trials by the same sponsor.

NCT07531277 — Developing Resource Interventions for Healthcare Professionals and Patients to Improve Knowledge About Fertility in Prim · NA · not yet recruiting
NCT06923943 — Predicting Nurse Staffing Requirements From Routinely Collected Data · active not recruiting
NCT06692959 — A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer · Phase 2 · recruiting
NCT06815120 — A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent · NA · not yet recruiting
NCT06566157 — PROMOTE: The Effect of a Six Week Prebiotic Supplementation on Wellbeing of Young Adults. · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03633474 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 University of Southampton
Last refreshed: 22 October 2019

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/NCT03633474.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing