> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/a-study-on-the-reactogenicity-safety-immune-response-and-88155bbb-4f7a-45d2-a8f2-42878e9347e9
> Record changed: 2026-10-13

# 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

NCT05298254

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

Phase

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

Participants

505

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

Lead sponsor

GlaxoSmithKline

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

Start date

2022-03-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

Number of sites

30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Title and summary

**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). 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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Phase**

Phase 1/Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Dates

**Completion date**

2025-06-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**First posted**

2022-03-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Registry last updated**

2025-09-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Primary completion date**

2025-06-12

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Start date**

2022-03-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Size and sites

**Actual participants**

505

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Participants**

505

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Protocol amendments**

10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Number of sites**

30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Lead sponsor**

GlaxoSmithKline

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Identifiers

**Registry ID**

NCT05298254

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**ClinicalTrials.gov ID**

NCT05298254

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masking description**

Data will be collected in an observer-blind manner.

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Outcomes

### Primary outcomes

1. Percentage of participants reporting each solicited administration site event  
Timeframe: Within 7 days after the first study intervention dose (administered at Day 1)  
The solicited administration site events are pain, redness and swelling.
2. Percentage of participants reporting each solicited administration site event  
Timeframe: Within 7 days after the second study intervention dose (administered at Day 29)  
The solicited administration site events are pain, redness and swelling.
3. Percentage of participants reporting each solicited systemic event  
Timeframe: 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.
4. Percentage of participants reporting each solicited systemic event  
Timeframe: 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.
5. Percentage of participants reporting unsolicited adverse events (AEs)  
Timeframe: 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.
6. Percentage of participants reporting unsolicited adverse events (AEs)  
Timeframe: 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.
7. Percentage of participants reporting medically attended events (MAEs)  
Timeframe: 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.
8. Percentage of participants reporting any serious adverse events (SAEs)  
Timeframe: 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.
9. Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)  
Timeframe: 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.
10. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study  
Timeframe: 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.
11. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study  
Timeframe: At Day 8
12. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study  
Timeframe: At Day 29
13. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study  
Timeframe: At Day 36
14. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study  
Timeframe: At Day 64
15. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study  
Timeframe: At pre-study intervention administration (Day 1)
16. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study  
Timeframe: At Day 8
17. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study  
Timeframe: At Day 29
18. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study  
Timeframe: At Day 36
19. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study  
Timeframe: At Day 57
20. Time-to-first confirmed HSV-2 RGH episode in Part II of the study  
Timeframe: 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.

### Secondary outcomes

1. Number of confirmed HSV-2 RGH episodes in Part II of the study  
Timeframe: 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.
2. Percentage of participants free from confirmed HSV-2 RGH episode in Part II of the study  
Timeframe: At 6 months after the last study intervention administration (Day 29)  
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.
3. Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the study  
Timeframe: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period  
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.
4. Number of days with RGH-associated symptoms during each confirmed HSV-2 RGH episode in Part II of the study  
Timeframe: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period  
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.
5. Number of days with confirmed HSV-2 genital herpes lesions in Part II of the study  
Timeframe: 14 days post-Dose 2 (Day 43) to end of RGH event reporting period  
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.
6. HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study  
Timeframe: At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)  
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.
7. Number of HSV-2 DNA shedding episodes in Part II of the study  
Timeframe: Day -28 to Day -1  
Number of HSV-2 shedding episodes during the 28-day swabbing period.
8. Number of HSV-2 DNA shedding episodes in Part II of the study  
Timeframe: Day 43 to Day 70  
Number of HSV-2 shedding episodes during the 28-day swabbing period.
9. Number of HSV-2 DNA shedding episodes in Part II of the study  
Timeframe: Day 181 to Day 208  
Number of HSV-2 shedding episodes during the 28-day swabbing period.
10. Duration of HSV-2 DNA shedding episodes in Part II of the study  
Timeframe: Day -28 to Day -1  
Number of days of a HSV-2 shedding episode.
11. Duration of HSV-2 DNA shedding episodes in Part II of the study  
Timeframe: Day 43 to Day 70  
Number of days of a HSV-2 shedding episode.
12. Duration of HSV-2 DNA shedding episodes in Part II of the study  
Timeframe: Day 181 to Day 208  
Number of days of a HSV-2 shedding episode.
13. Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study  
Timeframe: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
14. Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study  
Timeframe: At pre-study intervention administration (Day 1), Day 29 and Day 57
15. Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study  
Timeframe: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
16. Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study  
Timeframe: At pre-study intervention administration (Day 1), Day 29 and Day 57
17. 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  
Timeframe: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
18. 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  
Timeframe: At pre-study intervention administration (Day 1), Day 29 and Day 57
19. 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  
Timeframe: At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
20. 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  
Timeframe: At pre-study intervention administration (Day 1), Day 29 and Day 57

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Eligibility

**Sex**

All

**Age groups**

Adults

**Minimum age**

18 Years

**Maximum age**

60 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
- Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- 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,
  - 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.

### Exclusion criteria

Medical Conditions

- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- 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.
- 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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Sites

- GSK Investigational SitePhoenix, United States
- GSK Investigational SiteWichita, United States
- GSK Investigational SiteKansas City, United States
- GSK Investigational SiteRochester, United States
- GSK Investigational SiteRichmond, United States
- GSK Investigational SiteSeattle, United States
- GSK Investigational SiteDarlinghurst, Australia
- GSK Investigational SiteSydney, Australia
- GSK Investigational SiteAntwerp, Belgium
- GSK Investigational SiteBrussels, Belgium
- GSK Investigational SiteEdegem, Belgium
- GSK Investigational SiteGhent, Belgium
- GSK Investigational SiteMontreal, Canada
- GSK Investigational SiteTartu, Estonia
- GSK Investigational SiteBerlin, Germany
- GSK Investigational SiteBerlin, Germany
- GSK Investigational SiteBochum, Germany
- GSK Investigational SiteCologne, Germany
- GSK Investigational SiteFrankfurt, Germany
- GSK Investigational SiteHamburg, Germany
- GSK Investigational SiteBarcelona, Spain
- GSK Investigational SiteBarcelona, Spain
- GSK Investigational SiteMadrid, Spain
- GSK Investigational SiteMadrid, Spain
- GSK Investigational SiteMadrid, Spain

And 5 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## References

### Other registry identifiers

- 2021-003586-35

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05298254)

## Related records

### Drugs (2)

- [Clofarabine](https://trialight.com/data/asset/clofarabine-df6136eb-4ce5-4462-8034-d6d6374f0221.md)
- [Insulin efsitora alfa](https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25.md)

### Lead sponsors (1)

- [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md)

### Conditions (2)

- [Genital herpes](https://trialight.com/data/condition/genital-herpes-07f6bf40-9937-5924-bf15-bb89bedc2b84.md)
- [Herpes simplex infectious disease](https://trialight.com/data/condition/herpes-simplex-infectious-disease-e68e9e47-8d4d-542b-bba5-bb8aaa1ebd60.md) Primary condition

### Targets (14)

- [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md)
- [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md)
- [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md)
- [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md)
- [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md)
- [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md)
- [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md)
- [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md)
- [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md)
- [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md)
- [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md)
- [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md)
- [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md)
- [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md)

---

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