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

NCT05630859 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2161562022-500883-37-00
• Study Type: interventional
• Target: 1,004
• Locations: 8 countries
• Sites: 23

Brief Summary

The aim of this first time in human proof of concept (FTiH-PoC) study is 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).

Conditions

Sexually Transmitted Diseases

Keywords

Neisseria gonorrhoeae; Safety; Efficacy; Sexually transmitted infection; Healthy adults 18 to 50 years of age

Outcome Measures

Primary Outcomes (21)

• Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in)

  The solicited administration site events after vaccination include pain, redness, and swelling.

  During the 7 days follow-up period after the first dose

• Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in)

  The solicited administration site events after vaccination include pain, redness, and swelling.

  During the 7 days follow-up period after the second dose

• Percentage of participants reporting each solicited systemic event in study Phase 1 (Dose-escalation safety lead-in)

  The solicited systemic events after vaccination include fever, headache, myalgia, arthralgia, fatigue. Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

  During the 7 days follow-up period after the first dose

• Percentage of participants reporting each solicited systemic event in study Phase 1 (Dose-escalation safety lead-in)

  The solicited systemic events after vaccination include fever, headache, myalgia, arthralgia, fatigue. Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

  During the 7 days follow-up period after the second dose

• Percentage of participants reporting unsolicited adverse events (AEs) in study Phase 1 (Dose-escalation safety lead-in)

  Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

  During the 30 days follow-up period after the first dose

• Percentage of participants reporting unsolicited AEs in study Phase 1 (Dose-escalation safety lead-in)

  Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

  During the 30 days follow-up period after the second dose

• Percentage of participants reporting serious adverse events (SAEs) in study Phase 1 (Dose-escalation safety lead-in)

  An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in an abnormal pregnancy outcome.

  From Day 1 after the first dose up to study Phase I end (Day 241)

• Percentage of participants reporting AEs leading to withdrawal in study Phase 1 (Dose-escalation safety lead-in)

  An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention.

  From Day 1 after the first dose up to study Phase I end (Day 241)

• Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 1 (Dose-escalation safety lead-in)

  Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

  7 days after the first dose

• Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 1 (Dose-escalation safety lead-in)

  Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

  7 days after the second dose

• Incidence rates of confirmed gonorrhea cases in study Phase 2 [Efficacy Proof of Concept (PoC)]

  From 1 month to 13 months post-Dose 2

• Percentage of participants reporting solicited administration site events in study Phase 2 (Efficacy PoC)

  The solicited administration site events after vaccination include pain, redness, and swelling.

  During the 7 days follow-up period after the first dose

• Percentage of participants reporting solicited administration site events in study Phase 2 (Efficacy PoC)

  The solicited administration site events after vaccination include pain, redness, and swelling.

  During the 7 days follow-up period after the second dose

• Percentage of participants reporting each solicited systemic event in study Phase 2 (Efficacy PoC)

  The solicited systemic events after vaccination include fever, headache, myalgia, arthralgia, fatigue. Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

  During the 7 days follow-up period after the first dose

• Percentage of participants reporting each solicited systemic event in study Phase 2 (Efficacy PoC)

  The solicited systemic events after vaccination include fever, headache, myalgia, arthralgia, fatigue. Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study is the oral cavity.

  During the 7 days follow-up period after the second dose

• Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC)

  Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

  During the 30 days follow-up period after the first dose

• Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC)

  Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

  During the 30 days follow-up period after the second dose

• Percentage of participants reporting SAEs in study Phase 2 (Efficacy PoC)

  An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in an abnormal pregnancy outcome.

  From Day 1 after the first dose up to study end (Day 451)

• Percentage of participants reporting AEs leading to withdrawal in study Phase 2 (Efficacy PoC)

  An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention.

  From Day 1 after the first dose up to study end (Day 451)

• Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 2 (Efficacy PoC)

  Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. The evaluation of the endpoint will be assessed in the subsets for intensive safety monitoring.

  7 days after the first dose

• Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 2 (Efficacy PoC)

  Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

  7 days after the second dose

Secondary Outcomes (3)

• Incidence rates of confirmed gonorrhea cases with and without co-infection with a different sexually-transmitted disease causing bacterium in study Phase 2 (Efficacy PoC)

  From 1 month to 13 months post-Dose 2

• Incidence rates of gonorrhea in study Phase 2 (Efficacy PoC)

  From 1 month to 13 months post-Dose 2

• Incidence rates of other gonococcal infection with positive Ng in study Phase 2 (Efficacy PoC)

  From 1 month to 13 months post-Dose 2

Study Arms (9)

Phase 1:1a Low dose Group

EXPERIMENTAL

Participants randomized to the 1a Low dose Group receive 2 doses of NgG low dose investigational vaccine.

Biological: NgG low dose investigational vaccine

Phase 1:1b Placebo Group

PLACEBO COMPARATOR

Participants randomized to the 1b Placebo Group receive 2 doses of placebo.

Biological: Placebo

Phase 1: 2a Medium dose Group

EXPERIMENTAL

Participants randomized to the 2a Medium dose Group receive 2 doses of NgG medium dose investigational vaccine.

Biological: NgG medium dose investigational vaccine

Phase 1: 2b Placebo Group

PLACEBO COMPARATOR

Participants randomized to the 2b Placebo Group receive 2 doses of placebo.

Biological: Placebo

Phase 1: 3a High dose Group

EXPERIMENTAL

Participants randomized to the 3a High dose Group receive 2 doses of NgG high dose investigational vaccine.

Biological: NgG high dose investigational vaccine

Phase 1: 3b Placebo Group

PLACEBO COMPARATOR

Participants randomized to the 3b Placebo Group receive 2 doses of placebo.

Biological: Placebo

Phase 2: 4a HTD Group

EXPERIMENTAL

Participants randomized to the 4a highest tolerated dose (HTD) Group receive 2 doses of NgG highest tolerated dose selected from Phase 1.

Biological: NgG HTD investigational vaccine

Phase 2: 4b dose below HTD Group

EXPERIMENTAL

Participants randomized to the 4b dose below HTD Group receive 2 doses of NgG dose below the highest tolerated dose selected from Phase 1.

Biological: NgG below HTD investigational vaccine

Phase 2: 4c Placebo Group

PLACEBO COMPARATOR

Participants randomized to the 4c Placebo Group receive 2 doses of placebo.

Biological: Placebo

Interventions

NgG low dose investigational vaccine BIOLOGICAL

Two doses of NgG low dose investigational vaccine, administered intramuscularly.

Phase 1:1a Low dose Group

NgG medium dose investigational vaccine BIOLOGICAL

Two doses of NgG medium dose investigational vaccine, administered intramuscularly.

Phase 1: 2a Medium dose Group

NgG high dose investigational vaccine BIOLOGICAL

Two doses of NgG high dose investigational vaccine, administered intramuscularly.

Phase 1: 3a High dose Group

Placebo BIOLOGICAL

Two doses of placebo, administered intramuscularly.

Also known as: Sodium chloride (NaCl)

Phase 1: 2b Placebo Group; Phase 1: 3b Placebo Group; Phase 1:1b Placebo Group; Phase 2: 4c Placebo Group

NgG HTD investigational vaccine BIOLOGICAL

Two doses of NgG HTD investigational vaccine, administered intramuscularly.

Phase 2: 4a HTD Group

NgG below HTD investigational vaccine BIOLOGICAL

Two doses of NgG below HTD investigational vaccine, administered intramuscularly.

Phase 2: 4b dose below HTD Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (23)

GSK Investigational Site

Washington D.C., District of Columbia, 20009, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Springfield, Missouri, 65802, United States

Location

GSK Investigational Site

The Bronx, New York, 10467, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 48202, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Salvador, 41680-020, Brazil

Location

GSK Investigational Site

Lyon, 69004, France

Location

GSK Investigational Site

Paris, 75475, France

Location

GSK Investigational Site

Pierre-Bénite, 69495, France

Location

GSK Investigational Site

Bochum, 44787, Germany

Location

GSK Investigational Site

Frankfurt, 60596, Germany

Location

GSK Investigational Site

Hamburg, 20146, Germany

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Johannesburg, 2001, South Africa

Location

GSK Investigational Site

Soweto, 2013, South Africa

Location

GSK Investigational Site

Barcelona, 08015, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

London, SW10 9NH, United Kingdom

Location

GSK Investigational Site

London, WC1E 6JB, United Kingdom

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected in an observer-blind manner.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: November 30, 2022
• Study Start: November 28, 2022
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

FR (3); US (7); ZA (2); GB (2); PH (1); DE (3); ES (4); BR (1)