Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age

1. Medical conditions Dose-escalation safety lead-in part

* Any clinically significant biochemical laboratory abnormality.

* Any other clinical condition as determined by the investigator, that may increase participant's risk due to study participation.

* History of any reaction/hypersensitivity likely to be exacerbated by any component of the study intervention.

* Confirmed or suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination.

* Hypersensitivity to latex.

* Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality, as determined by physical examination/laboratory tests.

* Uncontrolled neurological disorders or seizures.

* History of invasive meningococcal disease. Efficacy PoC part: HIV negative intensive safety monitoring, HIV negative full enrollment and for all remaining participants

* Persons under guardianship or trusteeship.

* Persons deprived of liberty.

* Gonococcal infection identified within 14 days prior to randomization.

* Any other clinical condition as determined by the investigator, that may increase participant's risk due to study participation.

* History of severe allergic reactions and/anaphylaxis, or any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).

* Bleeding diathesis / any other condition that would contraindicate intramuscular administration.

* Confirmed or suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination.

* Known seropositivity for HIV infection, regardless of viremia and CD4 cell count

* Hypersensitivity to latex.

* Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality, as determined by physical examination/laboratory tests.

* Recurrent history/uncontrolled neurological disorders or seizures.

* History of invasive meningococcal disease.

Seropositivity for HIV infection if:

* CD4 cell count \< 350 cells/mm3 in the last 6 months

* viral load \> 50cp/ml in the last 6 months

* participant is not on antiretroviral therapy (ART) for \> 3 months or has switched from a different ART in the last 3 months.

For both Intensive safety monitoring subset (first 30 HIV negative subjects per group and first 8 HIV positive subjects per group) these criteria apply:

Any clinically significant hematological/biochemical laboratory abnormality.

2. Prior/Concomitant therapy Applicable for both the dose-escalation safety lead-in part and the PoC part

* Use of any investigational/non-registered product other than the study intervention(s) within 30 days before the first dose/planned use during the study period.

* Previous and planned vaccination with an OMV based Neisseria meningitidis group B vaccine (e.g., Bexsero, MeNZB vaccine or MenBvac at any time prior to first dose and during the entire study period.

* Planned administration/administration of a vaccine not specified in study protocol within 15 days before the first dose and ending 15 days after the last dose of vaccine administration.

* Administration of long-acting immune-modifying drugs during the period starting 6 months prior to the first dose of study intervention/planned administration at any time during the study period.

* Administration of immunoglobulins /any blood products/plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention/planned administration during the study period.

* Chronic administration (more than 14 days in total) of immunosuppressants/other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants/ ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.

The following criterion applies only for the PoC part:

• Chronic/long-term use of systemic antibiotics with an activity against Neisseria gonorrhoeae.

3. Prior/Concurrent clinical study experience applicable for both dose-escalation safety lead-in part and the PoC part Concurrently participating in another clinical study, at any time during the study period, in which the participant has been/will be exposed to an investigational/a non-investigational intervention.

4. Other exclusions applicable for both dose-escalation safety leading part and the PoC part

* Pregnant/lactating female.

* Female planning to become pregnant/to discontinue contraceptive precautions before 1 month after completion of the study intervention administration series.

* Any study personnel/their immediate dependents, family/household members.

* Lifestyle consideration that may interfere with the conduct of the study/pose additional risks to the rights and wellbeing of participants.

What this study is about