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Herpes Simplex Virus 2Phase 1NCT02571166

HSV529 Vaccine in HSV-2 Seropositive Adults

A Phase 1 study testing HSV529 and Valacyclovir in people with Herpes Simplex Virus 2, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Herpes Simplex Virus 2
What is being tested?
HSV529 and Valacyclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Nov 2015to 1 Dec 2018
Phase
Phase 1
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Subjects without a spleen.
  • Subjects receiving immunoglobulin within the past 6 months or anticipated receipt of immunoglobulin during the 28 days following each vaccination.
  • Bleeding disorder, or receipt of anticoagulants that, in the opinion of the Investigator, would interfere with the subject's participation in the trial.
  • Known allergy or intolerance to vaccine components [e.g., potassium glutamate (possible cross-reaction to monosodium glutamate), sucrose] or to a vaccine containing any of the same substances.
  • Known allergy or intolerance to silver nitrate or lidocaine.
  • Known allergy or intolerance to acyclovir or valacyclovir.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • History of keloid formation or excessive scarring.
  • History of frequent cellulitis or boils (>3 episodes in past 2 years) requiring antibiotic therapy.
  • Prior receipt of an HSV vaccine.
  • Any condition that the PI thinks might compromise the person's ability to comply with the requirements of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Washington Virology Research Clinic

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Phase I Study of the Genital Immune Response to Live, Attenuated HSV529 Vaccine in HSV-2 Seropositive Adults

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.

Read the detailed description

The investigators will enroll a cohort of 8-10 HIV-1 seronegative, HSV-2 seropositive persons with recurrent genital HSV-2 lesions in an area amenable to genital biopsy. Participants will enroll when they have a genital lesion. They will undergo a lesion biopsy and a non-lesion biopsy. They will start suppressive valacyclovir 500 mg po daily for 4 weeks. Three days after completion of the 4 week valacyclovir course, participants will initiate vaccination with HSV529 on a 0, 1, and 6 month dose schedule. At each vaccination visits and at the 10 days post vaccination visits, genital biopsies will be performed. Genital biopsies will be performed at the site of genital lesion and at a non-lesional genital site. PBMC will also be drawn. Two days after the second vaccination, an optional biopsy will be offered. Overall, a minimum of 14 genital biopsies will be performed for each participant: 7 at the genital lesion site, and 7 at the genital non-lesion site. Four control biopsies from the upper arm will also be performed. For participants who undergo the optional biopsy two days after Dose 2, two additional genital biopsies will be performed. Participants will also collect daily genital swabs for HSV PCR for 30 days after each vaccination.

Being tested
HSV529, Valacyclovir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSV529Biological

    Live, Replication-defective HSV-2 virus

  • ValacyclovirDrug

    500 mg orally, once daily for 4 weeks

Study groups in NCT02571166
Study groupRoleWhat they receive
HSV529ExperimentalNot described
Receives: Biological: HSV529; Drug: Valacyclovir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: one year

  2. 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

    Measured: one year

  3. TCR composition

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

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion1 Dec 2018
  4. Study completion1 Dec 2018

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02571166
Sponsor's protocol ID
49596-J
Other IDs
8377
Status last verified
Jan 2019
First submitted
13 Aug 2015
Last updated
14 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Ford ES, Li AZ, Laing KJ, Dong L, Diem K, Jing L, Mayer-Blackwell K, Basu K, Ott M, Tartaglia J, Gurunathan S, Reid JL, Ecsedi M, Chapuis AG, Huang ML, Magaret AS, Johnston C, Zhu J, Koelle DM, Corey L. Expansion of the HSV-2-specific T cell repertoire in skin after immunotherapeutic HSV-2 vaccine. JCI Insight. 2024 Jun 18;9(14):e179010. doi: 10.1172/jci.insight.179010.

    PubMed 39133650

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HSV529 and Valacyclovir in people with Herpes Simplex Virus 2, run by Fred Hutchinson Cancer Center at 1 site in United States.

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 10 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 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

Safety of HSV529 vaccine assessed by solicited Adverse Events, non-solicited Adverse Events and all Serious Adverse Events. (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02571166, which also lists 1 linked publication.

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 14 Jan 2019.

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