Herpes SimplexPhase 1/2NCT05298254
A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
A Phase 1/2 study testing Non-adjuvanted HSV formulation 1, Non-adjuvanted HSV formulation 2 and Non-adjuvanted HSV formulation 3 in people with Herpes Simplex, run by GlaxoSmithKline at 30 sites in 8 countries.
Trial summary
The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- Non-adjuvanted HSV formulation 1, Non-adjuvanted HSV formulation 2 and Non-adjuvanted HSV formulation 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 505 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 7 Mar 2022to 12 Jun 2025
- Phase
- Phase 1/2
- 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 60 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.
- Women of non-childbearing potential can be enrolled in the study.
- Women of childbearing potential can be enrolled in the study, if the participant:
- Has practiced highly effective contraception for one 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,
Show all 18Show fewer
- For PART I: Has agreed to continue highly effective contraception until the end of the study.
- For PART II: Has agreed to continue highly effective contraception until 3 months after last study intervention administration.
- Seronegative for human immunodeficiency virus (HIV), as determined by laboratory screening tests. Participants documented to be seropositive to HIV will not be eligible for study participation.
- Only for PART I: Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study.
- Only for PART I: Man or woman aged 18 to 40 years, included, at the time of the first study intervention administration.
- Only for PART I: Seronegative for HSV-2 as determined by Western blot performed at the Screening visit.
- Only for PART II: Participants with recurrent genital herpes and with no significant health problems as established by medical history and physical examination, at the discretion of the investigator, before entering the study.
- Diagnosis of genital herpes for at least one year before the Screening visit.
- History of self-reported or documented recurrent lesional genital herpes frequency of at least 3 and no more than 9 reported clinical recurrences in the 12 months preceding the screening visit, or, if still on suppressive therapy within 3 months before the Screening visit, prior to initiation of suppressive therapy.
- Only for PART II: Man or woman aged 18 to 60 years, included, at the time of the first study intervention administration.
- Only for PART II: Seropositive for HSV-2 as determined by serological testingperformed at the Screening visit, or having documented laboratory-confirmed HSV 2 genital herpes (i.e., HSV-2 DNA positive by a molecular technique such as polymerase chain reaction [PCR], or HSV-2 seropositive by a type-specific serology assay such as Western Blot or other immunoassay).Only for PART II (shedding sub-cohort): Participants agreeing to collect 2 swabs per day from anogenital area for the full duration of the 5 swabbing periods planned in the study.
- Only for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period.
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.
- 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 efficacy and 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, based on medical history and physical examination.
- Hypersensitivity to latex.
Show all 26Show fewer
- Recurrent history or uncontrolled neurological disorders or seizures.
- Haematological and/or biochemical parameters outside the normal laboratory ranges at the Screening visit, unless the laboratory abnormalities are considered not clinically significant by the investigator.
- Body mass index =<18 kg/m^2 or >=35 kg/m^2.
- Past or current Guillain-Barré syndrome.
- History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
- Prior/Concomitant Therapy
- Use of any investigational or non-registered product other than the study intervention during the period beginning as of the Screening visit, 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 intervention administration.
- Administration or planned 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 3 months before the first dose of study intervention or planned administration during the study period.
- Chronic administration 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, or equivalent. Inhaled, intra articular and topical steroids are allowed.
- Prior receipt of another vaccine containing HSV antigens.
- Only for PART II: Planned use of suppressive anti-HSV therapy from the Screening visit until the end of the study.
- Only for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study. Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
- Only for PART II: Planned use of any episodic antiviral medications during the swabbing periods (including the baseline period) (only for the shedding sub-cohort).
- 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.
- Other Exclusions
- Pregnant or lactating women.
- Woman planning to become pregnant or planning to discontinue contraceptive precautions in the period starting from the Screening visit up to 3 months post-last dose of study intervention.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United States6 sites
GSK Investigational Site
Kansas City, Missouri, 64114
GSK Investigational Site
Phoenix, Arizona, 85015
GSK Investigational Site
Richmond, Virginia, 23219
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Seattle, Washington, 98105
GSK Investigational Site
Wichita, Kansas, 67207
Germany6 sites
GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Berlin, 10439
GSK Investigational Site
Bochum, 44787
GSK Investigational Site
Cologne, 50674
GSK Investigational Site
Frankfurt, 60596
GSK Investigational Site
Hamburg, 20146
Spain6 sites
GSK Investigational Site
Barcelona, 08001
GSK Investigational Site
Barcelona, 08015
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Marbella, 29600
Belgium4 sites
GSK Investigational Site
Antwerp, 2000
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Ghent, 9000
United Kingdom4 sites
GSK Investigational Site
Brighton, BN2 1ES
GSK Investigational Site
Liverpool, L7 8XP
GSK Investigational Site
London, WC1E 6JB
GSK Investigational Site
Southampton, SO14 0YG
Australia2 sites
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Sydney, New South Wales, 2010
About this study
Official title: A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study will be conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.
- Conditions
- Herpes Simplex
- Being tested
- Non-adjuvanted HSV formulation 1, Non-adjuvanted HSV formulation 2, Non-adjuvanted HSV formulation 3, HSV formulation 1 with adjuvant 1, HSV formulation 2 with adjuvant 1
- Keywords
- First Time in Human, Healthy participants, Recurrent genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response, Efficacy
- Medical subject headings
- Herpes Simplex, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-adjuvanted HSV formulation 1Biological
Two doses of the non-adjuvanted HSV formulation 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Non-adjuvanted HSV formulation 2Biological
Two doses of the non-adjuvanted HSV formulation 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Non-adjuvanted HSV formulation 3Biological
Two doses of the non-adjuvanted HSV formulation 3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
HSV formulation 1 with adjuvant 1Biological
Two doses of the HSV formulation 1 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
HSV formulation 2 with adjuvant 1Biological
Two doses of the HSV formulation 2 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
HSV formulation 3 with adjuvant 1Biological
Two doses of the HSV formulation 3 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
HSV formulation 1 with adjuvant 2Biological
Two doses of the HSV formulation 1 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
HSV formulation 2 with adjuvant 2Biological
Two doses of the HSV formulation 2 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
HSV formulation 3 with adjuvant 2Biological
Two doses of the HSV formulation 3 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
PlaceboDrug
Two doses of Placebo administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I and Part II of the study.
HSVTI_F1Biological
Two doses of the formulation of the HSVTI_F1 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.
HSVTI_F2Biological
Two doses of the formulation of the HSVTI_F2 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.
| Study group | Role | What they receive |
|---|---|---|
| Non-adjuvanted HSV formulation 1 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29. Receives: Biological: Non-adjuvanted HSV formulation 1 |
| Non-adjuvanted HSV formulation 2 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29. Receives: Biological: Non-adjuvanted HSV formulation 2 |
| Non-adjuvanted HSV formulation 3 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29. Receives: Biological: Non-adjuvanted HSV formulation 3 |
| HSV formulation 1 with adjuvant 1 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. Receives: Biological: HSV formulation 1 with adjuvant 1 |
| HSV formulation 2 with adjuvant 1 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. Receives: Biological: HSV formulation 2 with adjuvant 1 |
| HSV formulation 3 with adjuvant 1 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. Receives: Biological: HSV formulation 3 with adjuvant 1 |
| HSV formulation 1 with adjuvant 2 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. Receives: Biological: HSV formulation 1 with adjuvant 2 |
| HSV formulation 2 with adjuvant 2 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. Receives: Biological: HSV formulation 2 with adjuvant 2 |
| HSV formulation 3 with adjuvant 2 - Part I Group | Experimental | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. Receives: Biological: HSV formulation 3 with adjuvant 2 |
| Placebo - Part I Group | Placebo comparator | Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. Receives: Drug: Placebo |
| HSVTI formulation (F) 1 - Part II Group | Experimental | Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI_F1 selected from Part I of the study, one at Day 1 and one at Day 29. Receives: Biological: HSVTI_F1 |
| HSVTI_F2 - Part II Group | Experimental | Participants enrolled in Part II of the study who receive 2 doses of the HSVTI_F2 selected from Part I of the study, one at Day 1 and one at Day 29. Receives: Biological: HSVTI_F2 |
| Placebo - Part II Group | Placebo comparator | Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting each solicited administration site event
The solicited administration site events are pain, redness and swelling.
Measured: Within 7 days after the first study intervention dose (administered at Day 1)
Percentage of participants reporting each solicited administration site event
The solicited administration site events are pain, redness and swelling.
Measured: Within 7 days after the second study intervention dose (administered at Day 29)
Percentage of participants reporting each solicited systemic event
The solicited systemic events are fever, fatigue, headache, 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 degree Fahrenheit (°F), regardless the location of measurement.
Measured: Within 7 days after the first study intervention dose (administered at Day 1)
Percentage of participants reporting each solicited systemic event
The solicited systemic events are fever, fatigue, headache, 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 degree Fahrenheit (°F), regardless the location of measurement.
Measured: Within 7 days after the second study intervention dose (administered at Day 29)
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Measured: Within 28 days after the first study intervention dose (administered at Day 1)
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Measured: Within 28 days after the second study intervention dose (administered at Day 29)
Percentage of participants reporting medically attended events (MAEs)
An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.
Measured: From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394)
Percentage of participants reporting any 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 participant or results in abnormal pregnancy outcomes.
Measured: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)
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 Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study
Clinically significant haematological and biochemical 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.
Measured: At pre-study intervention administration (Day 1)
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study
Measured: At Day 8
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study
Measured: At Day 29
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study
Measured: At Day 36
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study
Measured: At Day 64
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study
Measured: At pre-study intervention administration (Day 1)
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study
Measured: At Day 8
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study
Measured: At Day 29
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study
Measured: At Day 36
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study
Measured: At Day 57
Time-to-first confirmed HSV-2 RGH episode in Part II of the study
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
Measured: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Secondary outcomes (20)
Number of confirmed HSV-2 RGH episodes in Part II of the study
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
Measured: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Percentage of participants free from confirmed HSV-2 RGH episode in Part II of the study
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR.
Measured: At 6 months after the last study intervention administration (Day 29)
Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the study
During genital herpes recurrences, participants are asked to complete the HSC, a 13-item checklist of herpes symptoms, where respondents record the severity of symptoms on a 4-point scale where 0 indicates no symptom and a higher point for more symptoms and severity. Total scores range from 0 (no symptom) to 39 (severe symptoms). At the onset of the genital herpes recurrence, this questionnaire is to be completed once daily, until no lesions or symptoms are present. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
Measured: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Number of days with RGH-associated symptoms during each confirmed HSV-2 RGH episode in Part II of the study
Duration in days (i.e., number of days with RGH-associated symptoms) of each genital herpes recurrence is displayed by arm group. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
Measured: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Number of days with confirmed HSV-2 genital herpes lesions in Part II of the study
Number of days on which lesions (swelling, blisters, sores, or crusts) are reported by the participant in the anogenital area during confirmed RGH episodes divided by the number of days of follow-up. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
Measured: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study
The HSV-2 shedding rate reduction is calculated as 1- (the HSV-2 shedding rate one month post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
Measured: At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)
Number of HSV-2 DNA shedding episodes in Part II of the study
Number of HSV-2 shedding episodes during the 28-day swabbing period.
Measured: Day -28 to Day -1
Number of HSV-2 DNA shedding episodes in Part II of the study
Number of HSV-2 shedding episodes during the 28-day swabbing period.
Measured: Day 43 to Day 70
Number of HSV-2 DNA shedding episodes in Part II of the study
Number of HSV-2 shedding episodes during the 28-day swabbing period.
Measured: Day 181 to Day 208
Duration of HSV-2 DNA shedding episodes in Part II of the study
Number of days of a HSV-2 shedding episode.
Measured: Day -28 to Day -1
Duration of HSV-2 DNA shedding episodes in Part II of the study
Number of days of a HSV-2 shedding episode.
Measured: Day 43 to Day 70
Duration of HSV-2 DNA shedding episodes in Part II of the study
Number of days of a HSV-2 shedding episode.
Measured: Day 181 to Day 208
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study
Measured: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study
Measured: At pre-study intervention administration (Day 1), Day 29 and Day 57
Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study
Measured: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study
Measured: At pre-study intervention administration (Day 1), Day 29 and Day 57
Geometric mean of HSVTI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Measured: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Geometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Measured: At pre-study intervention administration (Day 1), Day 29 and Day 57
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Measured: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Measured: At pre-study intervention administration (Day 1), Day 29 and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start7 Mar 2022
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 505 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
- NCT05298254
- Sponsor's protocol ID
- 215336
- Other IDs
- 2021-003586-35
- Status last verified
- Aug 2025
- First submitted
- 4 Mar 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
- ClinicalTrials.gov ID
- NCT05298254
- Acronym / sponsor ID
- 215336
- Conditions
- Herpes Simplex
- Keywords
- First Time in Human, Healthy participants, Recurrent genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response, Efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 28 Mar 2022 (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 evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study will be conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Non-adjuvanted HSV formulation 1 - Part I Group | Experimental | Biological: Non-adjuvanted HSV formulation 1Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29. |
| Non-adjuvanted HSV formulation 2 - Part I Group | Experimental | Biological: Non-adjuvanted HSV formulation 2Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29. |
| Non-adjuvanted HSV formulation 3 - Part I Group | Experimental | Biological: Non-adjuvanted HSV formulation 3Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 1 with adjuvant 1 - Part I Group | Experimental | Biological: HSV formulation 1 with adjuvant 1Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 2 with adjuvant 1 - Part I Group | Experimental | Biological: HSV formulation 2 with adjuvant 1Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 3 with adjuvant 1 - Part I Group | Experimental | Biological: HSV formulation 3 with adjuvant 1Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 1 with adjuvant 2 - Part I Group | Experimental | Biological: HSV formulation 1 with adjuvant 2Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 2 with adjuvant 2 - Part I Group | Experimental | Biological: HSV formulation 2 with adjuvant 2Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 3 with adjuvant 2 - Part I Group | Experimental | Biological: HSV formulation 3 with adjuvant 2Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. |
| Placebo - Part I Group | Placebo comparator | Drug: PlaceboParticipants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. |
| HSVTI formulation (F) 1 - Part II Group | Experimental | Biological: HSVTI_F1Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI_F1 selected from Part I of the study, one at Day 1 and one at Day 29. |
| HSVTI_F2 - Part II Group | Experimental | Biological: HSVTI_F2Participants enrolled in Part II of the study who receive 2 doses of the HSVTI_F2 selected from Part I of the study, one at Day 1 and one at Day 29. |
| Placebo - Part II Group | Placebo comparator | Drug: PlaceboParticipants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 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.
- Women of non-childbearing potential can be enrolled in the study.
- Women of childbearing potential can be enrolled in the study, if the participant:
- Seronegative for human immunodeficiency virus (HIV), as determined by laboratory screening tests. Participants documented to be seropositive to HIV will not be eligible for study participation.
Key exclusion criteria (26 listed)
- Medical Conditions
- 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 efficacy and 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, based on medical history and physical examination.
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 |
|---|---|---|
| Non-adjuvanted HSV formulation 1Two doses of the non-adjuvanted HSV formulation 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | Non-adjuvanted HSV formulation 1 - Part I Group |
| Non-adjuvanted HSV formulation 2Two doses of the non-adjuvanted HSV formulation 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | Non-adjuvanted HSV formulation 2 - Part I Group |
| Non-adjuvanted HSV formulation 3Two doses of the non-adjuvanted HSV formulation 3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | Non-adjuvanted HSV formulation 3 - Part I Group |
| HSV formulation 1 with adjuvant 1Two doses of the HSV formulation 1 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | HSV formulation 1 with adjuvant 1 - Part I Group |
| HSV formulation 2 with adjuvant 1Two doses of the HSV formulation 2 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | HSV formulation 2 with adjuvant 1 - Part I Group |
| HSV formulation 3 with adjuvant 1Two doses of the HSV formulation 3 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | HSV formulation 3 with adjuvant 1 - Part I Group |
| HSV formulation 1 with adjuvant 2Two doses of the HSV formulation 1 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | HSV formulation 1 with adjuvant 2 - Part I Group |
| HSV formulation 2 with adjuvant 2Two doses of the HSV formulation 2 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | HSV formulation 2 with adjuvant 2 - Part I Group |
| HSV formulation 3 with adjuvant 2Two doses of the HSV formulation 3 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. | Biological | HSV formulation 3 with adjuvant 2 - Part I Group |
| PlaceboTwo doses of Placebo administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I and Part II of the study. | Drug | Placebo - Part I Group, Placebo - Part II Group |
| HSVTI_F1Two doses of the formulation of the HSVTI_F1 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study. | Biological | HSVTI formulation (F) 1 - Part II Group |
| HSVTI_F2Two doses of the formulation of the HSVTI_F2 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study. | Biological | HSVTI_F2 - Part II Group |
Primary outcome
Percentage of participants reporting each solicited administration site event
Time frame: Within 7 days after the first study intervention dose (administered at Day 1)
The solicited administration site events are pain, redness and swelling.
Percentage of participants reporting each solicited administration site event
Time frame: Within 7 days after the second study intervention dose (administered at Day 29)
The solicited administration site events are pain, redness and swelling.
Percentage of participants reporting each solicited systemic event
Time frame: Within 7 days after the first study intervention dose (administered at Day 1)
The solicited systemic events are fever, fatigue, headache, 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 degree Fahrenheit (°F), regardless the location of measurement.
Percentage of participants reporting each solicited systemic event
Time frame: Within 7 days after the second study intervention dose (administered at Day 29)
The solicited systemic events are fever, fatigue, headache, 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 degree Fahrenheit (°F), regardless the location of measurement.
Percentage of participants reporting unsolicited adverse events (AEs)
Time frame: Within 28 days after the first study intervention dose (administered at Day 1)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Percentage of participants reporting unsolicited adverse events (AEs)
Time frame: Within 28 days after the second study intervention dose (administered at Day 29)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Percentage of participants reporting medically attended events (MAEs)
Time frame: From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394)
An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.
Percentage of participants reporting any serious adverse events (SAEs)
Time frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.
Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)
Time frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
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 any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study
Time frame: At pre-study intervention administration (Day 1)
Clinically significant haematological and biochemical abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study
Time frame: At Day 8
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study
Time frame: At Day 29
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study
Time frame: At Day 36
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study
Time frame: At Day 64
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study
Time frame: At pre-study intervention administration (Day 1)
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study
Time frame: At Day 8
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study
Time frame: At Day 29
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study
Time frame: At Day 36
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study
Time frame: At Day 57
Time-to-first confirmed HSV-2 RGH episode in Part II of the study
Time frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
20 secondary outcomes
Number of confirmed HSV-2 RGH episodes in Part II of the study
Time frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Percentage of participants free from confirmed HSV-2 RGH episode in Part II of the study
Time frame: At 6 months after the last study intervention administration (Day 29)
Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the study
Time frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Number of days with RGH-associated symptoms during each confirmed HSV-2 RGH episode in Part II of the study
Time frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
Number of days with confirmed HSV-2 genital herpes lesions in Part II of the study
Time frame: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period
HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study
Time frame: At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)
Number of HSV-2 DNA shedding episodes in Part II of the study
Time frame: Day -28 to Day -1
Number of HSV-2 DNA shedding episodes in Part II of the study
Time frame: Day 43 to Day 70
Number of HSV-2 DNA shedding episodes in Part II of the study
Time frame: Day 181 to Day 208
Duration of HSV-2 DNA shedding episodes in Part II of the study
Time frame: Day -28 to Day -1
Duration of HSV-2 DNA shedding episodes in Part II of the study
Time frame: Day 43 to Day 70
Duration of HSV-2 DNA shedding episodes in Part II of the study
Time frame: Day 181 to Day 208
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study
Time frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study
Time frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study
Time frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study
Time frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
Geometric mean of HSVTI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Time frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Geometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Time frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Time frame: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Time frame: At pre-study intervention administration (Day 1), Day 29 and Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
Related trials for Herpes Simplex
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2
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
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
Cytomegalovirus Infection
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
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Non-adjuvanted HSV formulation 1, Non-adjuvanted HSV formulation 2 and Non-adjuvanted HSV formulation 3 in people with Herpes Simplex, run by GlaxoSmithKline at 30 sites in 8 countries.
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 18 inclusion and 26 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany, Spain, Belgium, United Kingdom and 3 more countries. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 each solicited administration site event (time frame: Within 7 days after the first study intervention dose (administered at Day 1)). The study lists 20 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 8 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.