Herpes SimplexPhase 1TH HSV REC-004NCT05989672
A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years
A Phase 1 study testing HSVTI Formulation 1 and HSVTI Formulation 2 in people with Herpes Simplex, run by GlaxoSmithKline at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- HSVTI Formulation 1 and HSVTI Formulation 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteJapan
- Study dates
- 8 Aug 2023to 24 Apr 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Herpes Simplex
- Being tested
- HSVTI Formulation 1, HSVTI Formulation 2, Placebo
- Keywords
- Herpes Simplex Virus genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSVTI Formulation 1Biological
This investigational intervention was administered intramuscularly to HSVTI_F1 Group.
HSVTI Formulation 2Biological
This investigational intervention was administered intramuscularly to HSVTI_F2 Group.
PlaceboBiological
This intervention was administered intramuscularly to Placebo group.
| Study group | Role | What they receive |
|---|---|---|
| Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group | Experimental | HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29. Receives: Biological: HSVTI Formulation 1 |
| HSVTI_Formulation 2 (F2) group | Experimental | HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29. Receives: Biological: HSVTI Formulation 2 |
| Placebo group | Placebo comparator | HSV-2 seronegative participants received placebo as control at Day 1 and Day 29. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Any Solicited Administration Site Events
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Solicited Administration Site Events
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Measured: During the 7 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Solicited Systemic Events
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever [temperature >=38.0-degree Celsius (°C)]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Measured: During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Solicited Systemic Events
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature >= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Measured: During the 7 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any 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. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 28 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Unsolicited 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. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 28 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Medically Attended Events (MAEs)
MAEs are defined as AEs 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. Any = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Serious Adverse Events (SAEs)
An 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. Any = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs)
plMDs are defined as a subset of adverse events of special interest (AESI) that include autoimmune diseases and other inflammatory or neurologic disorders that may or may not have an autoimmune etiology. Newly diagnosed pIMDs are categorized as new-onset conditions if they start following the administration of the study intervention. Any = occurrence of the symptom regardless of intensity grade.
Measured: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Exacerbation of pre-existing pIMDs is categorized as an exacerbation of a pre-existing chronic condition if the condition worsened following the administration of the study intervention.
Measured: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 1 (pre-study intervention administration)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 8 (7 days post dose 1)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 29 (28 days post dose 1)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 36 (7 days post dose 2)
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 57 (28 days post dose 2)
Secondary outcomes (8)
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody
The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL).
Measured: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Measured: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency
The geometric mean of HSVTI CD4+T cells frequency expressing at least 2 markers including at least one cytokine among Interferon [IFN]-gamma, Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-2, IL-13, IL-17, 4-1BB and CD40L were assessed by Intracellular staining (ICS).
Measured: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Geometric Mean of HSVTI-specific CD8+ T Cells Frequency
The geometric mean of HSVTI CD8+ T cells frequency expressing at least 2 activation markers including at least one cytokine among IFN-gamma, TNF-alpha, IL-2, IL-13, IL- 17, 4-1BB and CD40L were assessed by ICS.
Measured: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Number of Participants Reporting Any MAEs
Measured: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any SAEs
Measured: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Newly Diagnosed pIMDs
Measured: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Measured: From Day 1 (dose 1) up to study end (Day 209)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Aug 2023
- Primary completion29 Nov 2023
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989672
- Sponsor's protocol ID
- 218459
- Acronym
- TH HSV REC-004
- Status last verified
- Jun 2025
- First submitted
- 4 Aug 2023
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05989672
- Acronym / sponsor ID
- TH HSV REC-004 / 218459
- Conditions
- Herpes Simplex
- Keywords
- Herpes Simplex Virus genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group | Experimental | Biological: HSVTI Formulation 1HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29. |
| HSVTI_Formulation 2 (F2) group | Experimental | Biological: HSVTI Formulation 2HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29. |
| Placebo group | Placebo comparator | Biological: PlaceboHSV-2 seronegative participants received placebo as control at Day 1 and Day 29. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (25 listed)
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSVTI Formulation 1This investigational intervention was administered intramuscularly to HSVTI_F1 Group. | Biological | Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group |
| HSVTI Formulation 2This investigational intervention was administered intramuscularly to HSVTI_F2 Group. | Biological | HSVTI_Formulation 2 (F2) group |
| PlaceboThis intervention was administered intramuscularly to Placebo group. | Biological | Placebo group |
Primary outcome
Number of Participants Reporting Any Solicited Administration Site Events
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Solicited Administration Site Events
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 29
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Solicited Systemic Events
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever [temperature >=38.0-degree Celsius (°C)]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Solicited Systemic Events
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 29
The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature >= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 1
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. Any = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Unsolicited AEs
Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 29
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. Any = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Medically Attended Events (MAEs)
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
MAEs are defined as AEs 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. Any = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Serious Adverse Events (SAEs)
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
An 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. Any = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs)
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
plMDs are defined as a subset of adverse events of special interest (AESI) that include autoimmune diseases and other inflammatory or neurologic disorders that may or may not have an autoimmune etiology. Newly diagnosed pIMDs are categorized as new-onset conditions if they start following the administration of the study intervention. Any = occurrence of the symptom regardless of intensity grade.
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Exacerbation of pre-existing pIMDs is categorized as an exacerbation of a pre-existing chronic condition if the condition worsened following the administration of the study intervention.
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 1 (pre-study intervention administration)
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). 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.
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 8 (7 days post dose 1)
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). 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.
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 29 (28 days post dose 1)
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). 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.
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 36 (7 days post dose 2)
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). 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.
Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities
Time frame: At Day 57 (28 days post dose 2)
The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). 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.
8 secondary outcomes
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Geometric Mean of HSVTI-specific CD8+ T Cells Frequency
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Number of Participants Reporting Any MAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any SAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Newly Diagnosed pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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/
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RecruitingObservational study
Natural History Study of GATA2 Deficiency and Related Disorders
GATA2 Deficiency
RecruitingPhase 4
Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections.
Herpes Simplex
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSVTI Formulation 1 and HSVTI Formulation 2 in people with Herpes Simplex, run by GlaxoSmithKline at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Any Solicited Administration Site Events (time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.