A Human Controlled Infection Study With Neisseria Lactamica in Malian Adults

  • STATUS
    Recruiting
  • End date
    Jan 13, 2023
  • participants needed
    25
  • sponsor
    Center for Vaccine Development - Mali
Updated on 13 March 2021

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.

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.

Details
Condition Meningococcal meningitis
Treatment Intranasal inoculation with Neisseria lactamica
Clinical Study IdentifierNCT04665791
SponsorCenter for Vaccine Development - Mali
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

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 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note