Targeted Immunotherapy for Genital Herpes

No longer recruiting at 26 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: GlaxoSmithKline

Must not be taking: Immunosuppressants, Antivirals, others

Disqualifiers: HIV, Pulmonary, Cardiovascular, others

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for genital herpes to determine its safety and effectiveness. Researchers are exploring various delivery methods for the targeted immunotherapy to identify the best option. The trial includes individuals who experience multiple genital herpes outbreaks annually. Participants should have had recurrent genital herpes for at least a year, with 3 to 9 outbreaks in the past year. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in genital herpes treatment.

Will I have to stop taking my current medications?

For Part II of the trial, participants must stop using suppressive anti-HSV therapy, tenofovir, or other medications affecting HSV shedding or genital lesions, as well as topical antiviral medications in the anogenital region. If you are in Part I, the protocol does not specify stopping current medications, but you should discuss your specific situation with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the new herpes treatment being tested is generally safe. Earlier studies found that vaccines containing glycoprotein-D are safe and well tolerated. For instance, similar vaccines like gD2-AS04 demonstrated safety with few side effects. This suggests that the current treatment might also be well tolerated. Additionally, other studies have found that adjuvants, substances added to vaccines to enhance their effect, have not caused major safety issues when used with herpes vaccines.

Although the current trial is in its early stages, initial research suggests that the treatment is likely safe for humans. However, since this is the first time it is being tested in humans, researchers are closely monitoring safety to ensure all versions of the treatment are well tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these targeted immunotherapies for genital herpes because they represent a potential shift from traditional antiviral treatments like acyclovir, which primarily suppress symptoms. Unlike these standard antivirals, the investigational HSV formulations aim to boost the body's immune response to the virus itself, potentially reducing the frequency and severity of outbreaks. Additionally, the use of adjuvants in some formulations may enhance the body's immune reaction, offering a more robust and long-lasting defense against the virus. This approach could not only improve patient outcomes but also reduce the need for daily medication, making it a game-changer in herpes management.

What evidence suggests that this trial's treatments could be effective for genital herpes?

Research has shown that some new treatments for herpes hold promise in reducing symptoms of genital herpes. This trial tests various HSV formulations with different adjuvants. Studies have found that certain vaccines can decrease the shedding of the genital herpes virus (HSV-2) by 60%, leading to fewer outbreaks and a reduced chance of spreading the virus. One study showed a 58% protection rate against genital herpes caused by HSV-1, though it was less effective against HSV-2. Other treatments, like GEN-003, have significantly reduced the virus's presence and the number of sores. These findings suggest that these new vaccines, including those tested in this trial, could help manage genital herpes symptoms more effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18-40 or those aged 18-60 with recurrent genital herpes. Participants must not be pregnant, HIV positive, or have a history of severe reactions to vaccines. They should not be on antiviral therapy and must agree to avoid pregnancy during the study.

Inclusion Criteria

You need to have a negative pregnancy test before starting the study and before each treatment.

I have been diagnosed with genital herpes for over a year.

I have recurrent genital herpes and no major health issues.

Exclusion Criteria

I will not get vaccines not approved by the study 15 days before or after each treatment dose.

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

Pregnant or lactating women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of the investigational HSV-targeted immunotherapy, one at Day 1 and one at Day 29

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HSV-2 shedding and RGH episode tracking

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HSV formulation 1 with adjuvant 1
• HSV formulation 1 with adjuvant 2
• HSV formulation 2 with adjuvant 1
• HSV formulation 2 with adjuvant 2
• HSV formulation 3 with adjuvant 1
• HSV formulation 3 with adjuvant 2
• Non-adjuvanted HSV formulation 1
• Non-adjuvanted HSV formulation 2
• Non-adjuvanted HSV formulation 3
• Placebo
• Selected formulation

Trial Overview The study tests various formulations of an investigational HSV-targeted immunotherapy (HSVTI) in two parts: one part in healthy participants and another in those with recurrent genital herpes, comparing them against placebo to assess safety and effectiveness.

How Is the Trial Designed?

Group I: Non-adjuvanted HSV formulation 3 - Part I Group Experimental Treatment 1 Intervention

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.

Group II: Non-adjuvanted HSV formulation 2 - Part I Group Experimental Treatment 1 Intervention

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.

Group III: Non-adjuvanted HSV formulation 1 - Part I Group Experimental Treatment 1 Intervention

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.

Group IV: HSVTI_F2 - Part II Group Experimental Treatment 1 Intervention

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.

Group V: HSVTI formulation (F) 1 - Part II Group Experimental Treatment 1 Intervention

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.

Group VI: HSV formulation 3 with adjuvant 2 - Part I Group Experimental Treatment 1 Intervention

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.

Group VII: HSV formulation 3 with adjuvant 1 - Part I Group Experimental Treatment 1 Intervention

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.

Group VIII: HSV formulation 2 with adjuvant 2 - Part I Group Experimental Treatment 1 Intervention

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.

Group IX: HSV formulation 2 with adjuvant 1 - Part I Group Experimental Treatment 1 Intervention

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.

Group X: HSV formulation 1 with adjuvant 2 - Part I Group Experimental Treatment 1 Intervention

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.

Group XI: HSV formulation 1 with adjuvant 1 - Part I Group Experimental Treatment 1 Intervention

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.

Group XII: Placebo - Part I Group Placebo Group 1 Intervention

Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.

Group XIII: Placebo - Part II Group Placebo Group 1 Intervention

Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474238/

A Comparative Study on Immune Protection Efficacy: An HSV ... Results: After the challenge, the viral load in the tissues of both vaccine groups was significantly lower than that in the positive control ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11437400/

Toward the Eradication of Herpes Simplex Virus Three doses of the vaccine were 58% protective against culture-positive HSV-1 genital disease but not protective against HSV-2 infection or ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1103151

Efficacy Results of a Trial of a Herpes Simplex Vaccine However, efficacy against HSV-1 genital disease was 58% (95% CI, 12 to 80). Vaccine efficacy against HSV-1 infection (with or without disease) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24000550

Vaccine value profile for herpes simplex virus This 'Vaccine Value Profile' (VVP) for HSV is intended to provide a high-level, holistic assessment of the information and data that are currently available.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00057330

NCT00057330 | HerpeVac Trial for Young Women The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3901814/

Immunogenicity and safety of different formulations of an ... To further examine the efficacy of the candidate gD2-AS04 vaccine, a large efficacy trial involving 8,323 HSV-1 and HSV-2 seronegative women aged 18 to 30 years ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05298254

NCT05298254 | A Study on the Reactogenicity, Safety ... The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X25011181

Safety and immunogenicity of investigational herpes ... A randomized, placebo-controlled clinical trial was conducted over a two-dose schedule to assess various combinations of G103 and HSV529 with GLA-SE adjuvant in ...

9. tandfonline.com tandfonline.com/doi/abs/10.4161/hv.24043

Immunogenicity and safety of different formulations of an ... Immunogenicity and safety of different formulations of an adjuvanted glycoprotein D genital herpes vaccine in healthy adults. A double-blind randomized trial.

10. nejm.org nejm.org/doi/full/10.1056/NEJMoa011915

Glycoprotein-D–Adjuvant Vaccine to Prevent Genital Herpes The glycoprotein-D–alum–MPL vaccine was immunogenic, safe, and well tolerated. The primary efficacy end point in Study 1 was occurrence of genital herpes ...