A Human Controlled Infection Study with Neisseria Lactamica in Malian Adults

Inclusion Criteria:

• Healthy adults aged 18 to 45 years inclusive on the day of enrolment residingoutside the demographic surveillance area

• Able and willing (in the investigator's opinion) to understand and comply with allstudy 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 28visit is complete

• negative urine pregnancy test on the screening day

• negative urine pregnancy test on inoculation day

Exclusion Criteria:

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 residingoutside the demographic surveillance area

• Able and willing (in the investigator's opinion) to understand and comply with allstudy 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 28visit 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 aninvestigational product over the last 12 weeks or if there is planned use of aninvestigational 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, includingHIV infection; asplenia; recurrent, severe infections and chronic (more than 14days) immunosuppressant medication (including oral steroids) within the past 6months (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 screeninginvestigations

• History of any surgery to the nose or throat in the previous 3 months

• Any other significant disease, disorder, or finding which may significantly increasethe risk to the volunteer because of participation in the study, affect the abilityof the volunteer to participate in the study or impair interpretation of the studydata

• Occupational, household or intimate contact with immunosuppressed persons

• Positive pregnancy test or lactation