Herpes SimplexPhase 1NCT04762511
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
A Phase 1 study testing Lower dose formulation of HSV vaccine (GSK4108771A), Low dose formulation of HSV vaccine (GSK4108771A) and Medium dose formulation of HSV vaccine (GSK4108771A) in people with Herpes Simplex, run by GlaxoSmithKline at 2 sites in United States.
Trial 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. 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?
- Lower dose formulation of HSV vaccine (GSK4108771A), Low dose formulation of HSV vaccine (GSK4108771A) and Medium dose formulation of HSV vaccine (GSK4108771A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2021to 26 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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.
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Lenexa, Kansas, 66219
GSK Investigational Site
Rochester, New York, 14609
About this study
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
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.
- Conditions
- Herpes Simplex
- Being tested
- 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)
- Keywords
- First Time in Human, Vaccine, Healthy participants, 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.
Lower dose formulation of HSV vaccine (GSK4108771A)Biological
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.
Low dose formulation of HSV vaccine (GSK4108771A)Biological
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.
Medium dose formulation of HSV vaccine (GSK4108771A)Biological
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.
High dose formulation of HSV vaccine (GSK4108771A)Biological
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.
Placebo (saline)Drug
2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
| Study group | Role | What they receive |
|---|---|---|
| HSV lower dose formulation Group | Experimental | 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. Receives: Biological: Lower dose formulation of HSV vaccine (GSK4108771A) |
| Placebo Step 1 Group | Placebo comparator | Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. Receives: Drug: Placebo (saline) |
| HSV low dose formulation Group | Experimental | 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. Receives: Biological: Low dose formulation of HSV vaccine (GSK4108771A) |
| Placebo Step 2 Group | Placebo comparator | Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. Receives: Drug: Placebo (saline) |
| HSV medium dose formulation Group | Experimental | 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. Receives: Biological: Medium dose formulation of HSV vaccine (GSK4108771A) |
| Placebo Step 3 Group | Placebo comparator | Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. Receives: Drug: Placebo (saline) |
| HSV high dose formulation Group | Experimental | 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. Receives: Biological: High dose formulation of HSV vaccine (GSK4108771A) |
| Placebo Step 4 Group | Placebo comparator | Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. Receives: Drug: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after the first vaccine dose (administered at Day 1)
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.
Measured: Within 7 days after the second vaccine dose (administered at Day 57)
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.
Measured: Within 7 days after the first vaccine dose (administered at Day 1)
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.
Measured: Within 7 days after the second vaccine dose (administered at Day 57)
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.
Measured: Within 28 days after the first vaccine dose (administered at Day 1)
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.
Measured: Within 28 days after the second vaccine dose (administered at Day 57)
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.
Measured: From Day 1 up to study end at Day 421
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.
Measured: From Day 1 up to study end at Day 421
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.
Measured: From Day 1 up to study end at Day 421
Percentage of participants reporting potential orolabial HSV-1 recurrence
Potential orolabial HSV-1 recurrence represents a subset of adverse events of special interest (AESIs).
Measured: From Day 1 up to study end at Day 421
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.
Measured: At pre-vaccination (Day 1)
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.
Measured: At Day 2
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.
Measured: At Day 8
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.
Measured: At Day 57
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.
Measured: At Day 58
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.
Measured: At Day 64
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.
Measured: At Day 85
Secondary outcomes (4)
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).
Measured: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
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.
Measured: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
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).
Measured: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
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).
Measured: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start2 Mar 2021
- Primary completion26 May 2021
- Study completion26 May 2021
Why it stopped: To enable development of an enhanced version of the vaccine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762511
- Sponsor's protocol ID
- 213830
- Status last verified
- Jun 2021
- First submitted
- 17 Feb 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04762511
- Acronym / sponsor ID
- 213830
- Conditions
- Herpes Simplex
- Keywords
- First Time in Human, Vaccine, Healthy participants, Herpes Simplex Virus, Reactogenicity, Safety, Immune response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To enable development of an enhanced version of the vaccine
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HSV lower dose formulation Group | Experimental | Biological: Lower dose formulation of HSV vaccine (GSK4108771A)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. |
| Placebo Step 1 Group | Placebo comparator | Drug: Placebo (saline)Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. |
| HSV low dose formulation Group | Experimental | Biological: Low dose formulation of HSV vaccine (GSK4108771A)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. |
| Placebo Step 2 Group | Placebo comparator | Drug: Placebo (saline)Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. |
| HSV medium dose formulation Group | Experimental | Biological: Medium dose formulation of HSV vaccine (GSK4108771A)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. |
| Placebo Step 3 Group | Placebo comparator | Drug: Placebo (saline)Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. |
| HSV high dose formulation Group | Experimental | Biological: High dose formulation of HSV vaccine (GSK4108771A)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. |
| Placebo Step 4 Group | Placebo comparator | Drug: Placebo (saline)Healthy participants, 18 to 40 years of age, receive two doses of placebo (saline) intramuscularly, one at Day 1 and one at Day 57. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
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 |
|---|---|---|
| Lower dose formulation of HSV vaccine (GSK4108771A)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. | Biological | HSV lower dose formulation Group |
| Low dose formulation of HSV vaccine (GSK4108771A)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. | Biological | HSV low dose formulation Group |
| Medium dose formulation of HSV vaccine (GSK4108771A)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. | Biological | HSV medium dose formulation Group |
| High dose formulation of HSV vaccine (GSK4108771A)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. | Biological | HSV high dose formulation Group |
| Placebo (saline)2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57. | Drug | Placebo Step 1 Group, Placebo Step 2 Group, Placebo Step 3 Group, Placebo Step 4 Group |
Primary outcome
Percentage of participants reporting solicited administration site events within 7 days after the first vaccine dose administered at Day 1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From Day 1 up to study end at Day 421
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)
Time frame: From Day 1 up to study end at Day 421
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)
Time frame: From Day 1 up to study end at Day 421
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
Time frame: From Day 1 up to study end at Day 421
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Anti-vaccine antibody concentrations
Time frame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Percentage of seropositive participants for anti-vaccine antibodies
Time frame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Frequency of antigen specific Cluster of Differentiation (CD)4+ T-cells expressing at least two activation markers
Time frame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Frequency of antigen-specific CD8+ T-cells expressing at least two activation markers
Time frame: At pre-vaccination (Day 1), Day 29, Day 57, Day 85, Day 239 and Day 421
Results and safety
The study was stopped early (reason given: To enable development of an enhanced version of the vaccine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lower dose formulation of HSV vaccine (GSK4108771A), Low dose formulation of HSV vaccine (GSK4108771A) and Medium dose formulation of HSV vaccine (GSK4108771A) in people with Herpes Simplex, run by GlaxoSmithKline at 2 sites in United States.
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 11 inclusion and 23 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: stopped early, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study was stopped early (reason given: To enable development of an enhanced version of the vaccine). Results are not available in the source record.
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?
Percentage of participants reporting solicited administration site events within 7 days after the first vaccine dose administered at Day 1 (time frame: Within 7 days after the first vaccine dose (administered at Day 1)). The study lists 17 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 28 Jun 2021.