Back to resultsA Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
Primary Purpose
Herpes Simplex
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lower dose formulation of HSV vaccine (GSK4108771A)
Low dose formulation of HSV vaccine (GSK4108771A)
Medium dose formulation of HSV vaccine (GSK4108771A)
High dose formulation of HSV vaccine (GSK4108771A)
Placebo (saline)
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Simplex focused on measuring First Time in Human, Vaccine, Healthy participants, Herpes Simplex Virus, Reactogenicity, Safety, Immune response
Eligibility Criteria
Inclusion Criteria:
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
- Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- Man or woman aged 18-40 years, included, at the time of the first vaccination.
- Women of non-childbearing potential may be enrolled in the study.
Women of childbearing potential may be enrolled in the study, if the participant:
- Has practiced adequate contraception for one month prior to vaccination, and;
- Has a negative pregnancy test result on the day of vaccination, and;
- Has agreed to continue adequate contraception until the end of the study.
- Seronegative for HIV, as determined by laboratory screening tests. Participants documented to be positive to HIV will not be eligible for study participation.
- Seronegative for HSV-2 as determined by Western blot.
Exclusion Criteria:
Medical Conditions
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Hypersensitivity to latex.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Recurrent history or uncontrolled neurological disorders or seizures.
- Grade 2 or higher haematological and/or biochemical laboratory abnormality at screening.
- Body mass index ≤ 18 kg/m^2 or ≥ 35 kg/m^2.
- History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
- Participants with symptoms suggestive of Coronavirus disease 2019 (COVID-19) infection within 14 days before the first study vaccination. Participants should be free of symptoms for at least 14 days.
- Participants with known COVID-19-positive contacts in the past 14 days before the first study vaccination.
Prior/Concomitant Therapy
- Use of any investigational or non-registered product other than the study vaccines during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study vaccine administration.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting three months before the first dose of study vaccine or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting three months prior to the first study vaccine dose. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
- Prior receipt of another vaccine containing HSV-2 antigens. Prior/Concurrent Clinical Study Experience
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
Other Exclusions
- Pregnant or lactating woman.
- Woman planning to become pregnant or planning to discontinue contraceptive precautions.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
HSV lower dose formulation Group
Placebo Step 1 Group
HSV low dose formulation Group
Placebo Step 2 Group
HSV medium dose formulation Group
Placebo Step 3 Group
HSV high dose formulation Group
Placebo Step 4 Group
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of the HSV lower dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of the HSV low dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of the HSV medium dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of the HSV high dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Outcomes
Primary Outcome Measures
Percentage of participants reporting solicited administration site events within 7 days after the first vaccine dose administered at Day 1
The solicited administration site events are pain, redness and swelling.
Percentage of participants reporting solicited administration site events within 7 days after the second vaccine dose administered at Day 57
The solicited administration site events are pain, redness and swelling.
Percentage of participants reporting solicited systemic events within 7 days after the first vaccine dose administered at Day 1
The solicited systemic events are fever, fatigue, headache, nausea, vomiting, diarrhoea, abdominal pain, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4°F, regardless the location of measurement.
Percentage of participants reporting solicited systemic events within 7 days after the second vaccine dose administered at Day 57
The solicited systemic events are fever, fatigue, headache, nausea, vomiting, diarrhoea, abdominal pain, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4°F, regardless the location of measurement.
Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the first vaccine dose administered at Day 1
An unsolicited 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, whether or not considered related to the study intervention and that was not included in a list of solicited events using a Participant Diary.
Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the second vaccine dose administered at Day 57
An unsolicited 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, whether or not considered related to the study intervention and that was not included in a list of solicited events using a Participant Diary.
Percentage of participants reporting medically attended AEs (MAEs)
A MAE is an unsolicited AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Percentage of participants reporting serious adverse events (SAEs)
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 patient or results in abnormal pregnancy outcomes.
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
PIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Percentage of participants reporting potential orolabial HSV-1 recurrence
Potential orolabial HSV-1 recurrence represents a subset of adverse events of special interest (AESIs).
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-vaccination (Day 1)
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 2
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 58
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 85
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Secondary Outcome Measures
Anti-vaccine antibody concentrations
Antibody concentrations determined by Enzyme Linked Immunosorbent Assay (ELISA) are presented as GMCs and expressed in ELISA unit per milliliter (EU/mL).
Percentage of seropositive participants for anti-vaccine antibodies
The percentage of seropositive participants for anti-vaccine antibodies (i.e. participants with anti-vaccine antibody concentrations above the predefined threshold, as assessed by ELISA) is reported.
Frequency of antigen specific Cluster of Differentiation (CD)4+ T-cells expressing at least two activation markers
Frequency of antigen-specific CD4+ T-cells is expressed as antigen-specific CD4+ T-cells per million peripheral blood mononuclear cells (antigen-specific CD4+ T-cells/million PBMCs), as assessed by cytokine flow cytometry. Among the activation markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 4-1BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Frequency of antigen-specific CD8+ T-cells expressing at least two activation markers
Frequency of antigen-specific CD8+ T-cells is expressed as antigen-specific CD8+ T-cells/million PBMCs. Among the activation markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 4-1BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04762511
Brief Title
A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
Official Title
A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
To enable development of an enhanced version of the vaccine
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 18-40 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex
Keywords
First Time in Human, Vaccine, Healthy participants, Herpes Simplex Virus, Reactogenicity, Safety, Immune response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSV lower dose formulation Group
Arm Type
Experimental
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of the HSV lower dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Arm Title
Placebo Step 1 Group
Arm Type
Placebo Comparator
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Arm Title
HSV low dose formulation Group
Arm Type
Experimental
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of the HSV low dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Arm Title
Placebo Step 2 Group
Arm Type
Placebo Comparator
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Arm Title
HSV medium dose formulation Group
Arm Type
Experimental
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of the HSV medium dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Arm Title
Placebo Step 3 Group
Arm Type
Placebo Comparator
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Arm Title
HSV high dose formulation Group
Arm Type
Experimental
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of the HSV high dose formulation vaccine intramuscularly, one at Day 1 and one at Day 57.
Arm Title
Placebo Step 4 Group
Arm Type
Placebo Comparator
Arm Description
Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57.
Intervention Type
Biological
Intervention Name(s)
Lower dose formulation of HSV vaccine (GSK4108771A)
Intervention Description
2 doses of the lower dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
Intervention Type
Biological
Intervention Name(s)
Low dose formulation of HSV vaccine (GSK4108771A)
Intervention Description
2 doses of the low dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
Intervention Type
Biological
Intervention Name(s)
Medium dose formulation of HSV vaccine (GSK4108771A)
Intervention Description
2 doses of the medium dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
Intervention Type
Biological
Intervention Name(s)
High dose formulation of HSV vaccine (GSK4108771A)
Intervention Description
2 doses of the high dose formulation of the HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
Intervention Type
Drug
Intervention Name(s)
Placebo (saline)
Intervention Description
2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
Primary Outcome Measure Information:
Title
Percentage of participants reporting solicited administration site events within 7 days after the first vaccine dose administered at Day 1
Description
The solicited administration site events are pain, redness and swelling.
Time Frame
Within 7 days after the first vaccine dose (administered at Day 1)
Title
Percentage of participants reporting solicited administration site events within 7 days after the second vaccine dose administered at Day 57
Description
The solicited administration site events are pain, redness and swelling.
Time Frame
Within 7 days after the second vaccine dose (administered at Day 57)
Title
Percentage of participants reporting solicited systemic events within 7 days after the first vaccine dose administered at Day 1
Description
The solicited systemic events are fever, fatigue, headache, nausea, vomiting, diarrhoea, abdominal pain, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4°F, regardless the location of measurement.
Time Frame
Within 7 days after the first vaccine dose (administered at Day 1)
Title
Percentage of participants reporting solicited systemic events within 7 days after the second vaccine dose administered at Day 57
Description
The solicited systemic events are fever, fatigue, headache, nausea, vomiting, diarrhoea, abdominal pain, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4°F, regardless the location of measurement.
Time Frame
Within 7 days after the second vaccine dose (administered at Day 57)
Title
Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the first vaccine dose administered at Day 1
Description
An unsolicited 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, whether or not considered related to the study intervention and that was not included in a list of solicited events using a Participant Diary.
Time Frame
Within 28 days after the first vaccine dose (administered at Day 1)
Title
Percentage of participants reporting unsolicited adverse events (AEs) within 28 days after the second vaccine dose administered at Day 57
Description
An unsolicited 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, whether or not considered related to the study intervention and that was not included in a list of solicited events using a Participant Diary.
Time Frame
Within 28 days after the second vaccine dose (administered at Day 57)
Title
Percentage of participants reporting medically attended AEs (MAEs)
Description
A MAE is an unsolicited AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Time Frame
From Day 1 up to study end at Day 421
Title
Percentage of participants reporting serious adverse events (SAEs)
Description
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 patient or results in abnormal pregnancy outcomes.
Time Frame
From Day 1 up to study end at Day 421
Title
Percentage of participants reporting potential immune-mediated diseases (pIMDs)
Description
PIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame
From Day 1 up to study end at Day 421
Title
Percentage of participants reporting potential orolabial HSV-1 recurrence
Description
Potential orolabial HSV-1 recurrence represents a subset of adverse events of special interest (AESIs).
Time Frame
From Day 1 up to study end at Day 421
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-vaccination (Day 1)
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At pre-vaccination (Day 1)
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 2
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At Day 2
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At Day 8
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At Day 57
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 58
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At Day 58
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At Day 64
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 85
Description
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. In the absence of a diagnosis, abnormal laboratory findings assessments (e.g., Grade 2 or higher abnormal haematological and biochemical parameters) or other abnormal results the investigator considers clinically significant are recorded as an AE or SAE, if they meet the definition of an AE or SAE.
Time Frame
At Day 85
Secondary Outcome Measure Information:
Title
Anti-vaccine antibody concentrations
Description
Antibody concentrations determined by Enzyme Linked Immunosorbent Assay (ELISA) are presented as GMCs and expressed in ELISA unit per milliliter (EU/mL).
Time Frame
At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Title
Percentage of seropositive participants for anti-vaccine antibodies
Description
The percentage of seropositive participants for anti-vaccine antibodies (i.e. participants with anti-vaccine antibody concentrations above the predefined threshold, as assessed by ELISA) is reported.
Time Frame
At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Title
Frequency of antigen specific Cluster of Differentiation (CD)4+ T-cells expressing at least two activation markers
Description
Frequency of antigen-specific CD4+ T-cells is expressed as antigen-specific CD4+ T-cells per million peripheral blood mononuclear cells (antigen-specific CD4+ T-cells/million PBMCs), as assessed by cytokine flow cytometry. Among the activation markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 4-1BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Title
Frequency of antigen-specific CD8+ T-cells expressing at least two activation markers
Description
Frequency of antigen-specific CD8+ T-cells is expressed as antigen-specific CD8+ T-cells/million PBMCs. Among the activation markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 4-1BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ).
Time Frame
At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Healthy participants as established by medical history and clinical examination before entering into the study.
Man or woman aged 18-40 years, included, at the time of the first vaccination.
Women of non-childbearing potential may be enrolled in the study.
Women of childbearing potential may be enrolled in the study, if the participant:
Has practiced adequate contraception for one month prior to vaccination, and;
Has a negative pregnancy test result on the day of vaccination, and;
Has agreed to continue adequate contraception until the end of the study.
Seronegative for HIV, as determined by laboratory screening tests. Participants documented to be positive to HIV will not be eligible for study participation.
Seronegative for HSV-2 as determined by Western blot.
Exclusion Criteria:
Medical Conditions
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Hypersensitivity to latex.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Recurrent history or uncontrolled neurological disorders or seizures.
Grade 2 or higher haematological and/or biochemical laboratory abnormality at screening.
Body mass index ≤ 18 kg/m^2 or ≥ 35 kg/m^2.
History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
Participants with symptoms suggestive of Coronavirus disease 2019 (COVID-19) infection within 14 days before the first study vaccination. Participants should be free of symptoms for at least 14 days.
Participants with known COVID-19-positive contacts in the past 14 days before the first study vaccination.
Prior/Concomitant Therapy
Use of any investigational or non-registered product other than the study vaccines during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study vaccine administration.
Administration of long-acting immune-modifying drugs at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting three months before the first dose of study vaccine or planned administration during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting three months prior to the first study vaccine dose. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Prior receipt of another vaccine containing HSV-2 antigens. Prior/Concurrent Clinical Study Experience
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
Other Exclusions
Pregnant or lactating woman.
Woman planning to become pregnant or planning to discontinue contraceptive precautions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Learn more about this trial
A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
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