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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Sexually Transmitted Diseases

In brief

The aim of this first time in human proof of concept (FTiH-PoC) study was to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).

Key facts

Study ID

NCT05630859

Run by

GlaxoSmithKline

People needed

1009

Starts

2022-11-28

Expected to finish

2025-05-22

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion criteria for the dose-escalation safety lead-in part
• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
• Healthy participants as established by medical history, clinical examination, and laboratory assessment.
• A participant between and including 18 and 50 years of age at the time of informed consent.
• Female participants of non-childbearing potential may be enrolled in the study.
• Female participants of childbearing potential may be enrolled in the study if the participant:
• has practiced adequate contraception for 1 month prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
• Inclusion criteria for the efficacy PoC part
• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
• Healthy participants as established by:
• For the 2 intensive safety monitoring subsets (i.e., first 30 HIV negative subjects per group followed by first 8 HIV positive subjects per group): medical history, clinical examination, and laboratory assessment.
• For all the remaining participants: medical history, clinical examination.
• At risk for gonococcus infections based on sexual behavioral characteristics: this may include men having sex with men, pre-exposure prophylaxis for HIV users, individuals who engage in transactional sex participants with current or past STI diagnosis, participants at time of STI screening or seeking other STI services.
• A participant between and including 18 and 50 years of age at the time of informed consent. Transgender men and women, and other gender non-conforming people who identify themselves as neither men nor women may be enrolled into the study, based on their risk factors. For the purpose of this study, they will be followed up according to their biological sex (sex at birth), sexual orientation, and genital/sexual anatomy
• Participants of non-childbearing potential may be enrolled in the study. This includes transmen that have not undergone gender affirming surgery of their genitals.
• Participants of childbearing potential may be enrolled in the study if the participant:
• has practiced adequate contraception for 1 month prior to study intervention administration, and
• has a negative pregnancy test on the day of study intervention administration, and
• has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.

You may not qualify if…

• 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.
• The exclusion criteria depicted above, and the following exclusions criterion applies only for the HIV positive participants (intensive safety monitoring subset and full enrollment of HIV positive participants):
• 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

Where it is running

• GSK Investigational Site — Lyon, France
• GSK Investigational Site — Paris, France
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Lenexa, Kansas, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Springfield, Missouri, United States
• GSK Investigational Site — The Bronx, New York, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Salvador, Brazil
• GSK Investigational Site — Pierre-Bénite, France
• GSK Investigational Site — Bochum, Germany
• GSK Investigational Site — Frankfurt, Germany
• GSK Investigational Site — Hamburg, Germany
• GSK Investigational Site — Manila, Philippines
• GSK Investigational Site — Johannesburg, South Africa
• GSK Investigational Site — Soweto, South Africa
• GSK Investigational Site — Barcelona, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Madrid, Spain
• GSK Investigational Site — Valencia, Spain
• GSK Investigational Site — London, United Kingdom
• GSK Investigational Site — London, United Kingdom

Full record on ClinicalTrials.gov

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