Targeted Immunotherapy for Genital Herpes

Recruiting at 23 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

505 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new therapy to help the immune system fight herpes. It involves healthy adults and those with recurrent genital herpes. The treatment aims to boost the body's ability to combat the virus.

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.

What data supports the effectiveness of this treatment for genital herpes?

Research shows that adjuvants (substances that enhance the body's immune response to an antigen) can significantly boost the effectiveness of HSV vaccines by increasing specific antibody levels, which are linked to better protection. A vaccine with a specific adjuvant showed partial success in preventing genital herpes in women, suggesting that the choice of adjuvant is crucial for the treatment's effectiveness. ^{1 2 3 4 5}

Is the targeted immunotherapy for genital herpes safe for humans?

The targeted immunotherapy for genital herpes, including various HSV formulations with different adjuvants, has been shown to be safe in several large clinical trials. Studies have reported no significant safety concerns, with only mild side effects like low-grade fever and chills observed in some cases. ^{6 7 8 9 10}

How is the targeted immunotherapy for genital herpes different from other treatments?

This targeted immunotherapy for genital herpes is unique because it combines different HSV formulations with various adjuvants to potentially enhance the immune response, unlike standard antiviral medications that only suppress symptoms. The use of adjuvants (substances that enhance the body's immune response to an antigen) in this treatment aims to improve the effectiveness of the vaccine by boosting specific antibody responses, which is a novel approach compared to existing treatments. ^{1 4 5 11 12}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Large-scale comparison of experimental adjuvants with herpes simplex virus vaccine reveals a correlation of protection with IgG2a and IgG2b responses. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Vaccination strategies to prevent genital herpes and neonatal herpes simplex virus (HSV) disease. [2008]

3. Turkey pubmed.ncbi.nlm.nih.gov

[Herpes simplex virus vaccine studies: from past to present]. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Vaccines for herpes simplex virus infections. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Development of prophylactic vaccines for genital and neonatal herpes. [2008]

6. United States pubmed.ncbi.nlm.nih.gov

Correlate of immune protection against HSV-1 genital disease in vaccinated women. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Glycoprotein D adjuvant herpes simplex virus vaccine. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Vaccines for Herpes Simplex: Recent Progress Driven by Viral and Adjuvant Immunology. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Intratumoral Injection of HSV1716, an Oncolytic Herpes Virus, Is Safe and Shows Evidence of Immune Response and Viral Replication in Young Cancer Patients. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Nonclinical safety evaluation of two vaccine candidates for herpes simplex virus type 2 to support combined administration in humans. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Recent progress in herpes simplex virus immunobiology and vaccine research. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Neutralizing Antibody Kinetics and Immune Protection Against Herpes Simplex Virus 1 Genital Disease in Vaccinated Women. [2023]