Meningitis, BacterialEarly Phase 1NadA-Lac4NCT03630250

Challenge of the Nasopharynx With Neisseria Lactamica Expressing the Meningococcal Protein Neisseria Adhesin A (NadA)

A Early Phase 1 study testing N. lactamica in people with Meningitis, Bacterial and Neisseria Infection, run by University of Southampton at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Bacterial, Neisseria Infection
What is being tested?: N. lactamica
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited Kingdom
Study dates: 18 Oct 2018to 1 Sep 2019
Phase: Early Phase 1
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

The challenge volunteer must satisfy all the following inclusion criteria to be eligible for the study:
Healthy adults aged 18 to 45 years inclusive on the day of enrolment
Fully conversant in the English language
Able and willing (in the investigator's opinion) to comply with all study requirements
Provide written informed consent to participate in the trial
Provide written agreement to abide by infection control guidelines including agreement to abstain from intimate contact with any individual other than one declared and consented bedroom contact during the study period

Show all 13Show fewer

Provide written consent to allow the study team to discuss the volunteer's medical history with the General Practitioner
Written informed contact volunteer consent provided by any bedroom contact
Agreement to be admitted to Southampton NIHR-CRF for 4.5 days following inoculation
For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and inoculation
Able to correctly answer all questions in the pre-consent and infection control questionnaires
Agreement to take antibiotic eradication therapy according to the study protocol
TOPS registration completed and no conflict found

Who cannot join

The challenge volunteer may not enter the study if any of the following criteria apply:
Current active smokers defined as having smoked a cigarette or cigar in the last four weeks
N. lactamica or N. meningitidis detected on throat swab or nasal wash taken at screening or at the pre-challenge visit
Individuals who have a current infection 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
Individuals who have previously been involved in clinical trials investigating meningococcal vaccines or experimental challenge with N. lactamica

Show all 19Show fewer

Individuals who have received one or more doses of the meningococcus B vaccine Bexsero
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; malignancy, asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication 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 likely to be exacerbated by any component of the inoculum
Contraindications to the use of ciprofloxacin, specifically a history of epilepsy, prolonged QT interval, hypersensitivity to quinolones or a history of tendon disorders related to quinolone use
Contraindications to the use of ceftriaxone, specifically hypersensitivity to any cephalosporins
Any clinically significant abnormal finding on clinical examination or screening investigations. In the event of abnormal test results, confirmatory repeat tests will be requested.
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, for example recent surgery to the nasopharynx
Occupational, household or intimate contact with immunosuppressed persons, specifically HIV infection with a CD4 count <200 cells/mm3; asplenia; any malignancy, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (topical steroids are allowed)
Occupational or household contact with children under 5 years or an older child with a tendency to co-sleep with the volunteer
Pregnancy, lactation or intention to become pregnant during the study
Inability of the study team to contact the volunteer's GP to confirm medical history and safety to participate

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

NIHR Southampton Clinical Research Facility
Southampton

Other trials in United Kingdom

About this study

This study is part of a research programme that aims to improve ways of protecting people from serious illnesses such as meningitis and sepsis caused by a bacterium called Neisseria meningitidis (N. meningitidis), using a closely related but harmless bacterium called Neisseria lactamica (N. lactamica). Investigators have previously given nose drops containing N. lactamica to over 350 volunteers - this is known as inoculation. In these studies the investigators have shown that they can cause colonisation of many inoculated volunteers (35-60%) with N. lactamica. Colonisation is when bacteria survive on or in a person without causing any illness or disease. N. lactamica specifically colonises the nose and throat. Investigators have also shown that colonisation with N. lactamica results in an immune (antibody) response.

In this study investigators will be using a genetically modified version of N. lactamica which contains a single gene from N. meningitides. It is anticipated that the presence of this gene will change the number of people who are colonised and how long people remain colonised for, as well as causing them to produce an immune response to N. meningitides.

The purpose of this study are to prove that inoculation with this modified N. lactamica does not cause any symptoms or illness, and to analyse the immune response produced in healthy volunteers.

Read the detailed description

The NadA protein is one of the 4 strongly immunogenic components of the 4CMenB vaccine against serogroup B meningococcal disease (Bexsero) and has been demonstrated to be immunogenic in terms of generating serum bactericidal antibodies against N. meningitides strains that express the cognate NadA. Furthermore, University students vaccinated with Bexsero exhibit moderately reduced acquisition of nasopharyngeal carriage of N. meningitidis over the course of 12 months after vaccination. These studies imply that NadA expression by N. meningitidis may induce systemic and mucosal immunity to NadA during carriage, and that immunity directed against NadA may protect against colonisation by N. meningitidis. A greater understanding of the mucosal immune mechanisms of protection against pathobionts is essential for design of more effective and long lasting vaccines in the future. Then direct way to do this would be experimental human challenge with N. meningitidis but this carries potential hazard. As N. lactamica human challenge has shown to be safe, an alternative technique to investigate mucosal immunity to meningococcal antigens such as NadA will utilise Genetically Modified Organisms (GMOs) such as the one described here. Two strains of genetically modified N. lactamica will be used in this study, both of which have been derived from a beta-D-galactosidase (lacZ)-deficient mutant strain of N. lactamica Y92-1009 (△lacZ). This mutant can be differentiated from wild type bacteria when grown on the chromogenic substrate, X-gal. Both Genetically modified (GM) strains have demonstrated to remain acutely susceptible to killing by normal human serum and retain sensitivity to the front-line antibiotics used clinically to treat meningococcal disease (rifampicin, ciprofloxacin and ceftriaxone). The efficacy of ciprofloxacin to clear N. lactamica carriage is likely to similar as for N. meningitidis, as the organism is extremely sensitive to this antibiotic. Ciprofloxacin has been effective in clearing N. lactamica carriage within 24 hours in 100% of 4 individuals experimentally colonised in an ongoing human challenge study with wild type N. lactamica (unpublished data).

Conditions: Meningitis, Bacterial, Neisseria Infection
Being tested: N. lactamica
Keywords: meningitis, GMO
Medical subject headings: Meningitis, Bacterial, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

N. lactamicaBiological
Genetically modified N. lactamica

Study groups in NCT03630250
Study group	Role	What they receive
Challenge Volunteer - 4BN1	Experimental	Volunteers will be given a choice of which version of the GM N. lactamica they would like to be given (4BN1 or 4YB2). On Day 0 Challenge volunteers will be asked to lie on their back, 0.5 mL of fluid containing a carefully measured amount of 4BN1 will be dripped slowly into each nostril. The volunteer will be able to breathe through their mouth during the procedure. Volunteers will be asked to remain lying down for 15 minutes. This will be performed only once. Volunteers will then be admitted to the NIHR Southampton CRF for 5 days. Challenge volunteers will then be asked to return for follow up visits on Day 7, 10, 14, 28, 56 90 \& 92. A single dose of an antibiotic (Ciprofloxacin) will be administered on day 90 regardless of colonisation with modified N. lactamica 4BN1. Receives: Biological: N. lactamica
Contact Volunteer	No intervention	Contact volunteers are those volunteers whose partner/spouse is a Challenge volunteer. Investigators will monitor Contact volunteers to collect information about transmission. A single dose of an antibiotic (Ciprofloxacin) will be administered on Day 90 regardless of colonisation with modified N. lactamica.
Challenge Volunteer - 4YB2	Experimental	Volunteers will be given a choice of which version of the GM N. lactamica they would like to be given (4BN1 or 4YB2). On Day 0 Challenge volunteers will be asked to lie on their back, 0.5 mL of fluid containing a carefully measured amount of 4YB2 will be dripped slowly into each nostril. The volunteer will be able to breathe through their mouth during the procedure. Volunteers will be asked to remain lying down for 15 minutes. This will be performed only once. Volunteers will then be admitted to the NIHR Southampton CRF for 5 days. Challenge volunteers will then be asked to return for follow up visits on Day 7, 10, 14, 28, 56 90 \& 92. A single dose of an antibiotic (Ciprofloxacin) will be administered on day 90 regardless of colonisation with modified N. lactamica 4YB2 Receives: Biological: N. lactamica

What is being measured

The primary outcome is the main question the study is designed to answer.

Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring respiratory rate.
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Respiratory rate (breaths per minute) will be measured and compared with baseline measurements. A consistent increase in respiratory rate could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Measured: Up to volunteer visit Day 4
Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring body temperature.
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Body temperature (degrees Celsius) will be measured and compared with baseline measurements. A constant increase in body temperature could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Measured: Up to volunteer visit Day 4
Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring heart rate.
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Heart rate (beats per minute) will be measured and compared with baseline measurements. An increase in heart rate could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Measured: Up to volunteer visit Day 4
Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring blood pressure.
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Blood pressure (mmHg) will be measured and compared with baseline measurements. An increase in blood pressure could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Measured: Up to volunteer visit Day 4

Secondary outcomes (1)

To measure the NadA specific immunity in healthy volunteers following nasal inoculation with Neisseria lactamica expressing NadA
Colonisation by Neisseria lactamica has previously shown to elicit a mucosal antibody response. Saliva samples will be collected from volunteers and antibody levels (µg/mL) specific to NadA pre and post inoculation will be measured to confirm if there is an increase. Those volunteers successfully colonised are hypothesised to show an increase in antibody production.
Measured: Up to volunteer visit Day 92

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 20181 Sep 2019

First posted14 Aug 2018
Study start18 Oct 2018
Primary completion1 Sep 2019
Study completion1 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Meningitis, BacterialStudies 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: Early Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Cohort
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03630250
Sponsor's protocol ID: NadA-Lac4
Acronym: NadA-Lac4
Status last verified: Feb 2020
First submitted: 3 Aug 2018
Last updated: 27 Feb 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Laver JR, Hughes SE, Read RC. Neisserial Molecular Adaptations to the Nasopharyngeal Niche. Adv Microb Physiol. 2015;66:323-55. doi: 10.1016/bs.ampbs.2015.05.001. Epub 2015 May 30.
PubMed 26210107
Deasy AM, Guccione E, Dale AP, Andrews N, Evans CM, Bennett JS, Bratcher HB, Maiden MC, Gorringe AR, Read RC. Nasal Inoculation of the Commensal Neisseria lactamica Inhibits Carriage of Neisseria meningitidis by Young Adults: A Controlled Human Infection Study. Clin Infect Dis. 2015 May 15;60(10):1512-20. doi: 10.1093/cid/civ098. Epub 2015 Mar 25.
PubMed 25814628
Evans CM, Pratt CB, Matheson M, Vaughan TE, Findlow J, Borrow R, Gorringe AR, Read RC. Nasopharyngeal colonization by Neisseria lactamica and induction of protective immunity against Neisseria meningitidis. Clin Infect Dis. 2011 Jan 1;52(1):70-7. doi: 10.1093/cid/ciq065.
PubMed 21148522
Gbesemete D, Laver JR, de Graaf H, Ibrahim M, Vaughan A, Faust S, Gorringe A, Read RC. Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine. BMJ Open. 2019 May 1;9(4):e026544. doi: 10.1136/bmjopen-2018-026544.
PubMed 31048443

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Challenge of the Nasopharynx With Neisseria Lactamica Expressing the Meningococcal Protein Neisseria Adhesin A (NadA)
ClinicalTrials.gov ID: NCT03630250
Acronym / sponsor ID: NadA-Lac4 / NadA-Lac4
Conditions: Meningitis, Bacterial, Neisseria Infection
Keywords: meningitis, GMO
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of SouthamptonUniversity, hospital or other
Collaborators: University Hospital Southampton NHS Foundation Trust
Study start: 18 Oct 2018 (actual)
Primary completion: 1 Sep 2019 (actual)
Study completion: 1 Sep 2019 (actual)
First posted: 14 Aug 2018 (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.

The purpose of this study are to prove that inoculation with this modified N. lactamica does not cause any symptoms or illness, and to analyse the immune response produced in healthy volunteers.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Cohort

Arm	Type	Receives
Challenge Volunteer - 4BN1	Experimental	Biological: N. lactamicaVolunteers will be given a choice of which version of the GM N. lactamica they would like to be given (4BN1 or 4YB2). On Day 0 Challenge volunteers will be asked to lie on their back, 0.5 mL of fluid containing a carefully measured amount of 4BN1 will be dripped slowly into each nostril. The volunteer will be able to breathe through their mouth during the procedure. Volunteers will be asked to remain lying down for 15 minutes. This will be performed only once. Volunteers will then be admitted to the NIHR Southampton CRF for 5 days. Challenge volunteers will then be asked to return for follow up visits on Day 7, 10, 14, 28, 56 90 \& 92. A single dose of an antibiotic (Ciprofloxacin) will be administered on day 90 regardless of colonisation with modified N. lactamica 4BN1.
Contact Volunteer	No intervention	–Contact volunteers are those volunteers whose partner/spouse is a Challenge volunteer. Investigators will monitor Contact volunteers to collect information about transmission. A single dose of an antibiotic (Ciprofloxacin) will be administered on Day 90 regardless of colonisation with modified N. lactamica.
Challenge Volunteer - 4YB2	Experimental	Biological: N. lactamicaVolunteers will be given a choice of which version of the GM N. lactamica they would like to be given (4BN1 or 4YB2). On Day 0 Challenge volunteers will be asked to lie on their back, 0.5 mL of fluid containing a carefully measured amount of 4YB2 will be dripped slowly into each nostril. The volunteer will be able to breathe through their mouth during the procedure. Volunteers will be asked to remain lying down for 15 minutes. This will be performed only once. Volunteers will then be admitted to the NIHR Southampton CRF for 5 days. Challenge volunteers will then be asked to return for follow up visits on Day 7, 10, 14, 28, 56 90 \& 92. A single dose of an antibiotic (Ciprofloxacin) will be administered on day 90 regardless of colonisation with modified N. lactamica 4YB2

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

The challenge volunteer must satisfy all the following inclusion criteria to be eligible for the study:
Healthy adults aged 18 to 45 years inclusive on the day of enrolment
Fully conversant in the English language
Able and willing (in the investigator's opinion) to comply with all study requirements
Provide written informed consent to participate in the trial

Key exclusion criteria (19 listed)

Current active smokers defined as having smoked a cigarette or cigar in the last four weeks
N. lactamica or N. meningitidis detected on throat swab or nasal wash taken at screening or at the pre-challenge visit
Individuals who have a current infection 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
Individuals who have previously been involved in clinical trials investigating meningococcal vaccines or experimental challenge with N. lactamica

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
N. lactamicaGenetically modified N. lactamica	Biological	Challenge Volunteer - 4BN1, Challenge Volunteer - 4YB2

Primary outcome

Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring respiratory rate.
Time frame: Up to volunteer visit Day 4
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Respiratory rate (breaths per minute) will be measured and compared with baseline measurements. A consistent increase in respiratory rate could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring body temperature.
Time frame: Up to volunteer visit Day 4
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Body temperature (degrees Celsius) will be measured and compared with baseline measurements. A constant increase in body temperature could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring heart rate.
Time frame: Up to volunteer visit Day 4
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Heart rate (beats per minute) will be measured and compared with baseline measurements. An increase in heart rate could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.
Establish the effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring blood pressure.
Time frame: Up to volunteer visit Day 4
Volunteers are admitted to the NIHR Southampton CRF and closely observed by trained medical members for any potential effects. Blood pressure (mmHg) will be measured and compared with baseline measurements. An increase in blood pressure could indicate ill health and potential disease. A study doctor will review each participant twice a day for the duration of the inpatient stay.

1 secondary outcome

To measure the NadA specific immunity in healthy volunteers following nasal inoculation with Neisseria lactamica expressing NadA
Time frame: Up to volunteer visit Day 92

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 Feb 2020.
Background: PubMed 26210107Laver JR, Hughes SE, Read RC. Neisserial Molecular Adaptations to the Nasopharyngeal Niche. Adv Microb Physiol. 2015;66:323-55. doi: 10.1016/bs.ampbs.2015.05.001. Epub 2015 May 30.
Background: PubMed 25814628Deasy AM, Guccione E, Dale AP, Andrews N, Evans CM, Bennett JS, Bratcher HB, Maiden MC, Gorringe AR, Read RC. Nasal Inoculation of the Commensal Neisseria lactamica Inhibits Carriage of Neisseria meningitidis by Young Adults: A Controlled Human Infection Study. Clin Infect Dis. 2015 May 15;60(10):1512-20. doi: 10.1093/cid/civ098. Epub 2015 Mar 25.
Background: PubMed 21148522Evans CM, Pratt CB, Matheson M, Vaughan TE, Findlow J, Borrow R, Gorringe AR, Read RC. Nasopharyngeal colonization by Neisseria lactamica and induction of protective immunity against Neisseria meningitidis. Clin Infect Dis. 2011 Jan 1;52(1):70-7. doi: 10.1093/cid/ciq065.
Derived from this study: PubMed 31048443Gbesemete D, Laver JR, de Graaf H, Ibrahim M, Vaughan A, Faust S, Gorringe A, Read RC. Protocol for a controlled human infection with genetically modified Neisseria lactamica expressing the meningococcal vaccine antigen NadA: a potent new technique for experimental medicine. BMJ Open. 2019 May 1;9(4):e026544. doi: 10.1136/bmjopen-2018-026544.
Individual participant dataSharing planned: Undecided

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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 principal investigator

University of Southampton

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing N. lactamica in people with Meningitis, Bacterial and Neisseria Infection, run by University of Southampton at 1 site in United Kingdom.

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 13 inclusion and 19 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 Feb 2020. 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 United Kingdom. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 effect of the nasal inoculation of healthy volunteers with a genetically modified strain of Neisseria lactamica expressing NadA by measuring respiratory rate. (time frame: Up to volunteer visit Day 4). The study lists 4 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 NCT03630250, which also lists 4 linked publications.

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 Feb 2020.