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
Overview
- Phase
- Phase 1
- Intervention
- NgG medium dose investigational vaccine
- Conditions
- Sexually Transmitted Diseases
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1004
- Locations
- 1
- Primary Endpoint
- Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).
Investigators
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Phase 1: 2a Medium dose Group
Participants randomized to the 2a Medium dose Group receive 2 doses of NgG medium dose investigational vaccine.
Intervention: NgG medium dose investigational vaccine
Phase 1:1b Placebo Group
Participants randomized to the 1b Placebo Group receive 2 doses of placebo.
Intervention: Placebo
Phase 1:1a Low dose Group
Participants randomized to the 1a Low dose Group receive 2 doses of NgG low dose investigational vaccine.
Intervention: NgG low dose investigational vaccine
Phase 1: 2b Placebo Group
Participants randomized to the 2b Placebo Group receive 2 doses of placebo.
Intervention: Placebo
Phase 1: 3a High dose Group
Participants randomized to the 3a High dose Group receive 2 doses of NgG high dose investigational vaccine.
Intervention: NgG high dose investigational vaccine
Phase 1: 3b Placebo Group
Participants randomized to the 3b Placebo Group receive 2 doses of placebo.
Intervention: Placebo
Phase 2: 4a HTD Group
Participants randomized to the 4a highest tolerated dose (HTD) Group receive 2 doses of NgG highest tolerated dose selected from Phase 1.
Intervention: NgG HTD investigational vaccine
Phase 2: 4b dose below HTD Group
Participants randomized to the 4b dose below HTD Group receive 2 doses of NgG dose below the highest tolerated dose selected from Phase 1.
Intervention: NgG below HTD investigational vaccine
Phase 2: 4c Placebo Group
Participants randomized to the 4c Placebo Group receive 2 doses of placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of participants reporting solicited administration site events in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: During the 7 days follow-up period after the second dose
The solicited administration site events after vaccination include pain, redness, and swelling.
Percentage of participants reporting SAEs in study Phase 2 (Efficacy PoC)
Time Frame: From Day 1 after the first dose up to study end (Day 451)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in an abnormal pregnancy outcome.
Percentage of participants reporting each solicited systemic event in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: During the 7 days follow-up period after the second dose
The solicited systemic events after vaccination include fever, headache, myalgia, arthralgia, fatigue. Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Percentage of participants reporting unsolicited adverse events (AEs) in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: During the 30 days follow-up period after the first dose
Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of participants reporting unsolicited AEs in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: During the 30 days follow-up period after the second dose
Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of participants reporting serious adverse events (SAEs) in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: From Day 1 after the first dose up to study Phase I end (Day 241)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in an abnormal pregnancy outcome.
Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: 7 days after the second dose
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of participants reporting AEs leading to withdrawal in study Phase 1 (Dose-escalation safety lead-in)
Time Frame: From Day 1 after the first dose up to study Phase I end (Day 241)
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.
Percentage of participants with haematological and biochemical laboratory abnormalities in study Phase 2 (Efficacy PoC)
Time Frame: 7 days after the second dose
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Incidence rates of confirmed gonorrhea cases in study Phase 2 [Efficacy Proof of Concept (PoC)]
Time Frame: From 1 month to 13 months post-Dose 2
Percentage of participants reporting solicited administration site events in study Phase 2 (Efficacy PoC)
Time Frame: During the 7 days follow-up period after the second dose
The solicited administration site events after vaccination include pain, redness, and swelling.
Percentage of participants reporting each solicited systemic event in study Phase 2 (Efficacy PoC)
Time Frame: During the 7 days follow-up period after the second dose
The solicited systemic events after vaccination include fever, headache, myalgia, arthralgia, fatigue. Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study is the oral cavity.
Percentage of participants reporting unsolicited AEs in study Phase 2 (Efficacy PoC)
Time Frame: During the 30 days follow-up period after the second dose
Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Percentage of participants reporting AEs leading to withdrawal in study Phase 2 (Efficacy PoC)
Time Frame: From Day 1 after the first dose up to study end (Day 451)
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.
Secondary Outcomes
- Incidence rates of confirmed gonorrhea cases with and without co-infection with a different sexually-transmitted disease causing bacterium in study Phase 2 (Efficacy PoC)(From 1 month to 13 months post-Dose 2)
- Incidence rates of other gonococcal infection with positive Ng in study Phase 2 (Efficacy PoC)(From 1 month to 13 months post-Dose 2)
- Incidence rates of gonorrhea in study Phase 2 (Efficacy PoC)(From 1 month to 13 months post-Dose 2)