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A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years (TH HSV REC-004)

Primary Purpose

Herpes Simplex

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
HSVTI Formulation 1
HSVTI Formulation 2
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Herpes Simplex Virus genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). Written informed consent obtained from the participant prior to performance of any study-specific procedure. Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study. Man or woman aged 18 to 40 years, included, at the time of screening. Japanese ethnic origin (defined as having been born in Japan with 4 ethnic Japanese grandparents and able to speak Japanese). 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 highly effective contraception for 1 month prior to study intervention administration, and Has a negative pregnancy test result at the Screening visit and on the day of each study intervention administration, and Has agreed to continue highly effective contraception until Day 118, approximately 3 months post-Dose 2. Blood sample for simultaneous FSH and estradiol levels may be collected and tested locally at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range. • Seronegative for HSV-2 as determined by Western blot performed at the Screening visit. Exclusion Criteria: Medical conditions: Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests. Clinically significant abnormalities may include but are not limited to: evidence of cardiac damage, heart failure categorized as class II or greater according to the New York Heart Association functional classification, heart valve disease, pulmonary uncontrolled persistent asthma despite treatment, uncontrolled diabetes, or disease or disorder that may put the participant at risk or influence study results. Participants with a controlled underlying chronic co-morbidity may be enrolled, provided there have been no changes to their medication within 3 months prior to the Screening visit. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the immunogenicity assessments planned in this study. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. Any confirmed or suspected immunosuppressive or immunodeficient condition or documented or suspected HIV infection, based on medical history and physical examination (no laboratory testing required). Hypersensitivity to latex. Recurrent history of or uncontrolled neurological disorders or seizures. At the screening visit: hematological parameters (hemoglobin level, white blood cell, platelet) and/or biochemical parameters (ALT, AST, creatinine, blood urea nitrogen) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator. Body mass index =18 kg/m2 or =35 kg/m2. History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications (including meningitis, encephalitis, radiculopathy, myelitis). Prior/Concomitant therapy: Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning as of the Screening visit, or their planned use during the study period. Planned administration or administration of a vaccine* in the period starting 15 days* before each dose and ending 15 days* after each dose of study intervention administration**. * In case of adjuvanted and live-attenuated vaccines, this time window is to be increased to 30 days before and after each dose. In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. Administration or planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult participants. Inhaled, intra articular and topical steroids are allowed. Prior receipt of a vaccine containing HSV 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 intervention (drug or invasive medical device). Other exclusions: • Pregnant or lactating woman. Woman planning to become pregnant or planning to discontinue contraceptive precautions before Day 118 (approximately 3 months post-Dose 2).

Sites / Locations

  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

HSVTI_F1 group

HSVTI_F2 group

Placebo group

Arm Description

HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 1 of the study intervention at Day 1 and Day 29.

HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 2 of the study intervention at Day 1 and Day 29.

HSV-2 seronegative participants randomized in this group will receive 2 doses of placebo as control at Day 1 and Day 29.

Outcomes

Primary Outcome Measures

Percentage of participants with solicited administration site events
Assessed solicited administration site events include redness, pain, and swelling.
Percentage of participants with solicited systemic events
Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue.
Percentage of participants with unsolicited adverse events (AEs)
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
Percentage of participants reporting Medically Attended Events (MAEs)
MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Percentage of participants reporting Serious Adverse Events (SAEs)
A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Percentage of participants reporting any exacerbation of pre-existing pIMDs
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Percentage of participants reporting any hematological and biochemical laboratory abnormalities
The hematological and biochemical laboratory abnormalities will be assessed using a toxicity grading scale (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=potentially life-threatening). The hematological and biochemical laboratory parameters considered for this analysis are: hemoglobin, white blood cells increase and decrease, platelets decrease, alanine aminotransferase, aspartate aminotransferase, creatinine and blood urea nitrogen.

Secondary Outcome Measures

Anti-Herpes Simplex Virus Targeted Immunotherapy (HSVTI) antibody geometric mean concentration (GMC)
Anti-HSVTI antibody GMC will be measured in titers.
Seropositivity rate of anti-HSVTI antibody
The seropositivity rate of anti-HSVTI antibody will be Enzyme-Linked Immunosorbent Assay (ELISA) assessed and measured in ELISA Units pe milliliter (EU/mL).
Geometric mean of HSVTI-specific cluster of differentiation (CD)4+/CD8+ T cells frequency
The geometric mean of HSVTI CD4+/CD8+ T cells frequency will be assessed to cells expressing at least 2 activation markers (Interferon [IFN]-gamma, Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-2, IL-13, IL-17, 4-1BB and/or CD40L) and including at least one cytokine (assessed by cell glow cytometry [CFC]).
Percentage of participants reporting MAEs
MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Percentage of participants reporting SAEs
A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Percentage of participants reporting any exacerbation of pre-existing pIMDs
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.

Full Information

First Posted
August 4, 2023
Last Updated
August 18, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05989672
Brief Title
A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years
Acronym
TH HSV REC-004
Official Title
A Phase 1, Observer-blind, Randomized, Placebo-Controlled Study to Evaluate Reactogenicity, Safety and Immune Response of an HSV-targeted Immunotherapy in HSV-2 Seronegative Japanese Participants Aged 18-40 Years
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
November 27, 2023 (Anticipated)
Study Completion Date
May 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults 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
Herpes Simplex Virus genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Click here to enter text.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSVTI_F1 group
Arm Type
Experimental
Arm Description
HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 1 of the study intervention at Day 1 and Day 29.
Arm Title
HSVTI_F2 group
Arm Type
Experimental
Arm Description
HSV-2 seronegative participants randomized in this group will receive 2 doses of HSVTI Formulation 2 of the study intervention at Day 1 and Day 29.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
HSV-2 seronegative participants randomized in this group will receive 2 doses of placebo as control at Day 1 and Day 29.
Intervention Type
Biological
Intervention Name(s)
HSVTI Formulation 1
Intervention Description
This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F1 Group.
Intervention Type
Biological
Intervention Name(s)
HSVTI Formulation 2
Intervention Description
This investigational intervention will be administered intramuscular as 2 doses to HSVTI_F2 Group.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
This intervention will be administered intramuscular as 2 doses to Placebo group.
Primary Outcome Measure Information:
Title
Percentage of participants with solicited administration site events
Description
Assessed solicited administration site events include redness, pain, and swelling.
Time Frame
Within 7 days post-study intervention administration (i.e., the day of intervention and 6 subsequent days, study intervention administered on Day 1 and Day 29)
Title
Percentage of participants with solicited systemic events
Description
Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue.
Time Frame
Within 7 days post-study intervention administration (i.e., the day of intervention and 6 subsequent days, study intervention administered on Day 1 and Day 29)
Title
Percentage of participants with unsolicited adverse events (AEs)
Description
An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
Time Frame
Within 28 days post-study intervention administration (i.e., the day of intervention and 27 subsequent days, study intervention administered on Day 1 and Day 29)
Title
Percentage of participants reporting Medically Attended Events (MAEs)
Description
MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Time Frame
From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Title
Percentage of participants reporting Serious Adverse Events (SAEs)
Description
A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Title
Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)
Description
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Time Frame
From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Title
Percentage of participants reporting any exacerbation of pre-existing pIMDs
Description
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Time Frame
From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Title
Percentage of participants reporting any hematological and biochemical laboratory abnormalities
Description
The hematological and biochemical laboratory abnormalities will be assessed using a toxicity grading scale (where grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=potentially life-threatening). The hematological and biochemical laboratory parameters considered for this analysis are: hemoglobin, white blood cells increase and decrease, platelets decrease, alanine aminotransferase, aspartate aminotransferase, creatinine and blood urea nitrogen.
Time Frame
At Day 1 (pre-dose 1), Day 8 and Day 29 post-dose 1, and Day 36 and Day 57 post-dose 2
Secondary Outcome Measure Information:
Title
Anti-Herpes Simplex Virus Targeted Immunotherapy (HSVTI) antibody geometric mean concentration (GMC)
Description
Anti-HSVTI antibody GMC will be measured in titers.
Time Frame
At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Title
Seropositivity rate of anti-HSVTI antibody
Description
The seropositivity rate of anti-HSVTI antibody will be Enzyme-Linked Immunosorbent Assay (ELISA) assessed and measured in ELISA Units pe milliliter (EU/mL).
Time Frame
At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Title
Geometric mean of HSVTI-specific cluster of differentiation (CD)4+/CD8+ T cells frequency
Description
The geometric mean of HSVTI CD4+/CD8+ T cells frequency will be assessed to cells expressing at least 2 activation markers (Interferon [IFN]-gamma, Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-2, IL-13, IL-17, 4-1BB and/or CD40L) and including at least one cytokine (assessed by cell glow cytometry [CFC]).
Time Frame
At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Title
Percentage of participants reporting MAEs
Description
MAEs are defined as adverse events requiring medically-attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason.
Time Frame
From Day 1 (dose 1) up to Day 209 (end of study)
Title
Percentage of participants reporting SAEs
Description
A SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
From Day 1 (dose 1) up to Day 209 (end of study)
Title
Percentage of participants reporting any newly diagnosed Potential Immune-Mediated Diseases (pIMDs)
Description
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Time Frame
From Day 1 (dose 1) up to Day 209 (end of study)
Title
Percentage of participants reporting any exacerbation of pre-existing pIMDs
Description
Potential immune-mediated diseases (pIMDs) are defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology.
Time Frame
From Day 1 (dose 1) up to Day 209 (end of study)

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 (e.g., completion of the diary cards, return for follow-up visits). Written informed consent obtained from the participant prior to performance of any study-specific procedure. Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study. Man or woman aged 18 to 40 years, included, at the time of screening. Japanese ethnic origin (defined as having been born in Japan with 4 ethnic Japanese grandparents and able to speak Japanese). 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 highly effective contraception for 1 month prior to study intervention administration, and Has a negative pregnancy test result at the Screening visit and on the day of each study intervention administration, and Has agreed to continue highly effective contraception until Day 118, approximately 3 months post-Dose 2. Blood sample for simultaneous FSH and estradiol levels may be collected and tested locally at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range. • Seronegative for HSV-2 as determined by Western blot performed at the Screening visit. Exclusion Criteria: Medical conditions: Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests. Clinically significant abnormalities may include but are not limited to: evidence of cardiac damage, heart failure categorized as class II or greater according to the New York Heart Association functional classification, heart valve disease, pulmonary uncontrolled persistent asthma despite treatment, uncontrolled diabetes, or disease or disorder that may put the participant at risk or influence study results. Participants with a controlled underlying chronic co-morbidity may be enrolled, provided there have been no changes to their medication within 3 months prior to the Screening visit. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the immunogenicity assessments planned in this study. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. Any confirmed or suspected immunosuppressive or immunodeficient condition or documented or suspected HIV infection, based on medical history and physical examination (no laboratory testing required). Hypersensitivity to latex. Recurrent history of or uncontrolled neurological disorders or seizures. At the screening visit: hematological parameters (hemoglobin level, white blood cell, platelet) and/or biochemical parameters (ALT, AST, creatinine, blood urea nitrogen) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator. Body mass index =18 kg/m2 or =35 kg/m2. History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications (including meningitis, encephalitis, radiculopathy, myelitis). Prior/Concomitant therapy: Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning as of the Screening visit, or their planned use during the study period. Planned administration or administration of a vaccine* in the period starting 15 days* before each dose and ending 15 days* after each dose of study intervention administration**. * In case of adjuvanted and live-attenuated vaccines, this time window is to be increased to 30 days before and after each dose. In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. Administration or planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, this will mean prednisone equivalent =20 mg/day for adult participants. Inhaled, intra articular and topical steroids are allowed. Prior receipt of a vaccine containing HSV 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 intervention (drug or invasive medical device). Other exclusions: • Pregnant or lactating woman. Woman planning to become pregnant or planning to discontinue contraceptive precautions before Day 118 (approximately 3 months post-Dose 2).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Facility Information:
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years

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