Brief 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 (saline).
Brief Title
Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age
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.
* 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.
Completion Date
Completion Date Type
Actual
Conditions
SEXUALLY TRANSMITTED DISEASES
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion criteria:
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.
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.
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.
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.
Exclusion criteria:
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.
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.
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.
Inclusion Criteria
Inclusion Criteria:
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.
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.
Gender
All
Gender Based
false
Keywords
Neisseria gonorrhoeae
Safety
Efficacy
Sexually transmitted infection
Healthy adults 18 to 50 years of age
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
50 Years
Minimum Age
18 Years
NCT Id
NCT05630859
Org Class
Industry
Org Full Name
GlaxoSmithKline
Org Study Id
216156
Overall Status
Completed
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Outcome Measure
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Outcome Time Frame
From Day 1 to Day 7
Outcome Description
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Outcome Measure
Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Outcome Time Frame
From Day 61 to Day 67
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Outcome Time Frame
From Day 1 to Day 7
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Outcome Time Frame
From Day 61 to Day 67
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Outcome Time Frame
From Day 1 to Day 30
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants Reporting Any Unsolicited AEs
Outcome Time Frame
From Day 61 to Day 90
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
Outcome Time Frame
From Day 1 after the first dose to Day 241
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Outcome Time Frame
At Day 8 compared to baseline (Day 1)
Outcome Description
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.
Outcome Measure
Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Outcome Time Frame
At Day 68 compared to baseline (Day 61)
Outcome Description
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.
Outcome Measure
Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Outcome Time Frame
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Outcome Description
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Outcome Measure
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Outcome Time Frame
From Day 1 to Day 7
Outcome Description
Assessed solicited administration site events included injection site pain, erythema (redness), and swelling. Any = occurrence of the event regardless of intensity grade.
Outcome Measure
Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Outcome Time Frame
From Day 61 to Day 67
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Outcome Time Frame
From Day 1 to Day 7
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Outcome Time Frame
From Day 61 to Day 67
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants Reporting Any Unsolicited AEs
Outcome Time Frame
From Day 1 to Day 30
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants Reporting Any Unsolicited AEs
Outcome Time Frame
From Day 61 to Day 90
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
Outcome Time Frame
From Day 1 after the first dose to Day 451
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
Outcome Time Frame
At Day 8 compared to baseline (Day 1)
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
Outcome Time Frame
At Day 8 compared to baseline (Day 1)
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
Outcome Time Frame
At Day 68 compared to baseline (Day 61)
Outcome Description
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.
Outcome Measure
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
Outcome Time Frame
At Day 68 compared to baseline (Day 61)
Secondary Ids
Secondary Id
2022-500883-37-00
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Outcome Measure
Phase 2: Incidence Rates of Confirmed Gonorrhea Cases With and Without Chlamydia Trachomatis Co-infection
Outcome Description
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.
Outcome Time Frame
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
Outcome Measure
Phase 2: Incidence Rates of Symptomatic and Confirmed Gonorrhea Cases
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
50
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Barry Zingman
Investigator Email
bzingman@montefiore.org
Investigator Phone
718-920-2647
Categories Mesh Debug
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
MeSH Terms
SEXUALLY TRANSMITTED DISEASES
COMMUNICABLE DISEASES
INFECTIONS
GENITAL DISEASES
UROGENITAL DISEASES
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SODIUM CHLORIDE
CHLORIDES
HYDROCHLORIC ACID
CHLORINE COMPOUNDS
INORGANIC CHEMICALS
SODIUM COMPOUNDS