HSV529 Vaccine in HSV-2 Seropositive Adults

NCT02571166 | Completed Phase 1 DMC

• 2 other identifiers: 49596-J8377
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the safety of HSV529 vaccine in healthy volunteers with HSV infection and to determine if administration of the HSV529 vaccine increases the immune response in genital skin.

Conditions

Herpes Simplex Virus 2

Outcome Measures

Primary Outcomes (3)

• Safety of HSV529 vaccine assessed by solicited Adverse Events, non-solicited Adverse Events and all Serious Adverse Events.

  To determine the safety of HSV529 vaccine we will assess solicited Adverse Events, non-solicited Adverse Events and all Serious Adverse Events.

  one year

• T cell density

  Change in density of total CD4+, CD4+ Foxp3+, and CD8+ T cells in the genital mucosa at sites of lesions prior to and post HSV529 vaccination

  one year

• TCR composition

  Change in the diversity and clonality of TCR composition pre and post vaccination

  one year

Study Arms (1)

HSV529

EXPERIMENTAL

Biological: HSV529; Drug: Valacyclovir

Interventions

HSV529 BIOLOGICAL

Live, Replication-defective HSV-2 virus

HSV529

Valacyclovir DRUG

500 mg orally, once daily for 4 weeks

HSV529

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HSV-2 seropositive by UW Western blot with a history of recurrent genital herpes, with lesions in an area amenable to biopsy.
• Aged 18 to 55 years on the day of enrollment.
• In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits.
• Hemoglobin, hematocrit, white blood cell count, platelet count, serum creatinine, and liver function (ALT, AST, alkaline phosphatase, total bilirubin) screening laboratory results do not fall into the range of values that are Grade 1 or greater as per the toxicity grading scale.
• Female subjects must be of non-childbearing potential i.e. surgically sterilized (bilateral tubal ligation, hysterectomy) or, if of child-bearing potential and sexually active with a male partner, she must be willing to use a highly effective method of contraception (e.g., intrauterine device (IUD); oral contraceptives, diaphragm or condom in combination with contraceptive foam, jelly or cream; Norplant, DepoProvera, contraceptive skin patch or cervical ring) for at least 30 days prior to vaccination and until 30 days after final vaccination or be in a monogamous relationship with a male partner who has undergone a vasectomy at least 6 months prior to first dose of HSV529.
• Willingness to attend all scheduled visits and able to comply with all trial procedures (e.g., blood draws, biopsies, completion of diary cards, return for follow-up visits, accessible by phone or pager, able to self-sample for assessment of asymptomatic shedding of HSV, and not planning on moving from study area).
• HIV seronegative.
• Subject is willing not to use antiviral therapy 3 days before each injection and during swabbing periods. If recurrences occur during swabbing periods, participants will be asked NOT to take antiviral therapy.
• Subject is willing to forgo receipt of a licensed, live vaccine in the 30 days preceding each dose of vaccine or in the 30 days following each dose of vaccine. The inactivated flu vaccine can be used ≥14 days before or ≥14 days after administration of study vaccine, if this is felt to be necessary.
• Persons who have close contact with infants or immunocompromised individuals are willing to avoid such contact for 3 days after each injection.

You may not qualify if:

• Subject is pregnant or nursing OR planning to become pregnant in the timeframe that begins 30 days prior to the first vaccination and ends 30 days after the third vaccination.
• Body Mass Index greater than 35.
• Hepatitis C seropositive
• Hepatitis B surface antigen positive
• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination or planned participation during the study period up to 6 months after the last dose of vaccine. The non-interventional follow-up for an earlier study (e.g., long-term surveillance) will be allowed.
• Severe active infection or serious HSV-2 related or unrelated medical conditions that, in the opinion of the investigator, would prevent study completion.
• Subjects with 9 or more symptomatic recurrences of genital herpes disease within the year prior to Day 0.
• A history of HSV infection of the eye (e.g., herpes simplex interstitial keratitis or uveitis).
• A history of herpes gladiatorum, herpetic whitlow or eczema herpeticum.
• A history of lesions caused by HSV on either arm.
• A history of herpes-associated erythema multiforme.
• A history of a clinically significant autoimmune disorder.
• Known or suspected congenital or acquired immunodeficiency.
• Receipt of anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
• Subjects using corticosteroids (excluding topical, inhaled or nasal) or any immunomodulating drugs (see Prohibited Medications Section) within 42 days prior to the first vaccination. An immunosuppressive dose of corticosteroids is defined as ≥10 mg prednisone equivalent per day for \>14 days.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• University of Washington: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Valacyclovir

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christine Johnston, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

• Lawrence Corey, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: October 8, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

US (1)