Sexually Transmitted DiseasesPhase 1/2NCT05630859
Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
A Phase 1/2 study testing NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine and NgG 50 µg investigational vaccine in people with Sexually Transmitted Diseases, run by GlaxoSmithKline at 23 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine and NgG 50 µg investigational vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,009 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 28 Nov 2022to 22 May 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States7 sites
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Pittsburgh, Pennsylvania, 48202
GSK Investigational Site
Springfield, Missouri, 65802
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Washington D.C., District of Columbia, 20009
Spain4 sites
GSK Investigational Site
Barcelona, 08015
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Valencia, 46026
France3 sites
GSK Investigational Site
Lyon, 69004
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Pierre-Bénite, 69495
Germany3 sites
GSK Investigational Site
Bochum, 44787
GSK Investigational Site
Frankfurt, 60596
GSK Investigational Site
Hamburg, 20146
South Africa2 sites
GSK Investigational Site
Johannesburg, 2001
GSK Investigational Site
Soweto, 2013
United Kingdom2 sites
GSK Investigational Site
London, SW10 9NH
GSK Investigational Site
London, WC1E 6JB
About this study
Official title: A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
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).
Read the detailed description
The study included the following parts:
- Phase 1 - Dose-escalation safety lead-in in healthy participants.
- Phase 2 - Efficacy PoC in healthy participants considered at risk for gonorrhea.
The doses to be tested for efficacy would be selected based on the safety evaluation performed during the dose-escalation safety lead-in: in case more than one dose would show tolerability, the highest tolerated dose (HTD) and the dose below the highest tolerated (i.e., 2 doses) would be advanced in the efficacy PoC part of the study and compared versus placebo. In case only the lowest dose shows adequate tolerability, this would be the only dose tested in the PoC versus placebo.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine, NgG 50 µg investigational vaccine, Placebo
- Keywords
- Neisseria gonorrhoeae, Safety, Efficacy, Sexually transmitted infection, Healthy adults 18 to 50 years of age
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NgG 12.5 µg investigational vaccineBiological
2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly.
NgG 25 µg investigational vaccineBiological
2 doses of NgG 25 µg investigational vaccine administered intramuscularly.
NgG 50 µg investigational vaccineBiological
2 doses of NgG 50 µg investigational vaccine administered intramuscularly.
PlaceboCombination product
Also called Sodium chloride (NaCl)
2 doses of placebo administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group | Experimental | Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61. Receives: Biological: NgG 12.5 µg investigational vaccine |
| Phase 1: NgG 25 µg Group | Experimental | Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61. Receives: Biological: NgG 25 µg investigational vaccine |
| Phase 1: NgG 50 µg Group | Experimental | Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61. Receives: Biological: NgG 50 µg investigational vaccine |
| Phase 1: Placebo Group | Placebo comparator | Participants received 2 doses of placebo on Day 1 and Day 61. Receives: Combination Product: Placebo |
| Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group | Experimental | Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1. Receives: Biological: NgG 50 µg investigational vaccine |
| Phase 2: NgG dose below HTD (bHTD; 25 µg) Group | Experimental | Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1. Receives: Biological: NgG 25 µg investigational vaccine |
| Phase 2: Placebo Group | Placebo comparator | Participants received 2 doses of placebo on Day 1 and Day 61. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 7
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 61 to Day 67
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 7
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 61 to Day 67
Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 30
Phase 1: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 61 to Day 90
Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. 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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 after the first dose to Day 241
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
The safety laboratory data included haematological parameters [hemoglobin, lymphocytes, platelets, neutrophils, and white blood cells (WBC)] and biochemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 8 compared to baseline (Day 1)
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: At Day 68 compared to baseline (Day 61)
Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Incidence of first confirmed gonorrhea cases by positive Nucleic Acid Amplification Test (NAAT) at the anorectal and/or urogenital location were evaluated. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Measured: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 7
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 61 to Day 67
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 7
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 61 to Day 67
Phase 2: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 to Day 30
Phase 2: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 61 to Day 90
Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. 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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Measured: From Day 1 after the first dose to Day 451
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 8 compared to baseline (Day 1)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: At Day 8 compared to baseline (Day 1)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: At Day 68 compared to baseline (Day 61)
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Measured: At Day 68 compared to baseline (Day 61)
Secondary outcomes (2)
Phase 2: Incidence Rates of Confirmed Gonorrhea Cases With and Without Chlamydia Trachomatis Co-infection
Confirmed gonorrhea cases by positive NAAT with and without chlamydia trachomatis co-infection at the pharyngeal and/or anorectal and/or urogenital location are reported. The incidence rate (y/PT) of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Measured: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Phase 2: Incidence Rates of Symptomatic and Confirmed Gonorrhea Cases
Symptomatic gonorrhea cases which were later confirmed gonorrhea cases are reported. Symptomatic gonorrhea cases are defined as participants with symptoms suggestive of gonorrhea at the infected anatomical site which were later confirmed by a positive NAAT at the anorectal and/or urogenital location. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Measured: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start28 Nov 2022
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630859
- Sponsor's protocol ID
- 216156
- Other IDs
- 2022-500883-37-00
- Status last verified
- May 2026
- First submitted
- 25 Nov 2022
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Observer-blind, Randomized, Placebo-controlled Multi-country Study to Assess Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
- ClinicalTrials.gov ID
- NCT05630859
- Acronym / sponsor ID
- 216156
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Neisseria gonorrhoeae, Safety, Efficacy, Sexually transmitted infection, Healthy adults 18 to 50 years of age
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,009 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study included the following parts:
- Phase 1 - Dose-escalation safety lead-in in healthy participants.
- Phase 2 - Efficacy PoC in healthy participants considered at risk for gonorrhea.
The doses to be tested for efficacy would be selected based on the safety evaluation performed during the dose-escalation safety lead-in: in case more than one dose would show tolerability, the highest tolerated dose (HTD) and the dose below the highest tolerated (i.e., 2 doses) would be advanced in the efficacy PoC part of the study and compared versus placebo. In case only the lowest dose shows adequate tolerability, this would be the only dose tested in the PoC versus placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group | Experimental | Biological: NgG 12.5 µg investigational vaccineParticipants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61. |
| Phase 1: NgG 25 µg Group | Experimental | Biological: NgG 25 µg investigational vaccineParticipants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61. |
| Phase 1: NgG 50 µg Group | Experimental | Biological: NgG 50 µg investigational vaccineParticipants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61. |
| Phase 1: Placebo Group | Placebo comparator | Combination Product: PlaceboParticipants received 2 doses of placebo on Day 1 and Day 61. |
| Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group | Experimental | Biological: NgG 50 µg investigational vaccineParticipants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61. The HTD was selected based on the safety evaluation performed in Phase 1. |
| Phase 2: NgG dose below HTD (bHTD; 25 µg) Group | Experimental | Biological: NgG 25 µg investigational vaccineParticipants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61. The bHTD is selected based on the safety evaluation performed in Phase 1. |
| Phase 2: Placebo Group | Placebo comparator | Combination Product: PlaceboParticipants received 2 doses of placebo on Day 1 and Day 61. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (43 listed)
- Medical conditions Dose-escalation safety lead-in part
- 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):
- 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.
- Prior/Concomitant therapy Applicable for both the dose-escalation safety lead-in part and the PoC part
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NgG 12.5 µg investigational vaccine2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly. | Biological | Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group |
| NgG 25 µg investigational vaccine2 doses of NgG 25 µg investigational vaccine administered intramuscularly. | Biological | Phase 1: NgG 25 µg Group, Phase 2: NgG dose below HTD (bHTD; 25 µg) Group |
| NgG 50 µg investigational vaccine2 doses of NgG 50 µg investigational vaccine administered intramuscularly. | Biological | Phase 1: NgG 50 µg Group, Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group |
| PlaceboAlso: Sodium chloride (NaCl)2 doses of placebo administered intramuscularly. | Combination product | Phase 1: Placebo Group, Phase 2: Placebo Group |
Primary outcome
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Time frame: From Day 1 to Day 7
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Time frame: From Day 61 to Day 67
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Time frame: From Day 1 to Day 7
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Time frame: From Day 61 to Day 67
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Time frame: From Day 1 to Day 30
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants Reporting Any Unsolicited AEs
Time frame: From Day 61 to Day 90
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
Time frame: From Day 1 after the first dose to Day 241
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. 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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Time frame: At Day 8 compared to baseline (Day 1)
The safety laboratory data included haematological parameters [hemoglobin, lymphocytes, platelets, neutrophils, and white blood cells (WBC)] and biochemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Time frame: At Day 68 compared to baseline (Day 61)
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Time frame: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Incidence of first confirmed gonorrhea cases by positive Nucleic Acid Amplification Test (NAAT) at the anorectal and/or urogenital location were evaluated. The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Time frame: From Day 1 to Day 7
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Time frame: From Day 61 to Day 67
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Time frame: From Day 1 to Day 7
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Time frame: From Day 61 to Day 67
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia). Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants Reporting Any Unsolicited AEs
Time frame: From Day 1 to Day 30
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants Reporting Any Unsolicited AEs
Time frame: From Day 61 to Day 90
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
Time frame: From Day 1 after the first dose to Day 451
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. 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. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact. Any = occurrence of the event regardless of intensity grade.
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
Time frame: At Day 8 compared to baseline (Day 1)
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
Time frame: At Day 8 compared to baseline (Day 1)
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
Time frame: At Day 68 compared to baseline (Day 61)
The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
Time frame: At Day 68 compared to baseline (Day 61)
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine). Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g. ALT, Within, Within). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
2 secondary outcomes
Phase 2: Incidence Rates of Confirmed Gonorrhea Cases With and Without Chlamydia Trachomatis Co-infection
Time frame: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Phase 2: Incidence Rates of Symptomatic and Confirmed Gonorrhea Cases
Time frame: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NgG 12.5 µg investigational vaccine, NgG 25 µg investigational vaccine and NgG 50 µg investigational vaccine in people with Sexually Transmitted Diseases, run by GlaxoSmithKline at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Spain, France, Germany, South Africa and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events (time frame: From Day 1 to Day 7). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.