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Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection

Phase I Study of the Safety of a Replication-Defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection

NCT01915212•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

Background: \- Herpes simplex virus type 2 (HSV-2) is a major cause of genital herpes. It can also cause serious infection in newborns and in people with weakened immune systems. It increases the risk of getting an HIV infection and of spreading HIV to someone else. Therefore, a vaccine that could prevent genital herpes could improve the general health of the world s population. Researchers want to study whether a new vaccine, HSV529, which may be used in the future to prevent herpes infections, is safe. Objectives: \- To test whether a new herpes vaccine is safe. Eligibility: \- Healthy adults 18 40 years old. Design: * Participants will have 3 vaccination visits, 7 follow-up visits, and 3 follow-up phone calls over 1 year. * Each vaccination visit will last about 4 hours. * Participants will be screened with a medical history and physical exam. * Participants will have a blood sample taken. * Participants will be given the vaccine or a placebo, by injection from a needle. They will be monitored for 30 minutes to check for any allergic reaction. * Participants will be given a diary card to record any symptoms they may feel later. * At follow-up visits, participants will give a blood sample and answer health questions. * In the phone calls, participants will answer health questions.

Detailed Description

Herpes simplex virus 2 (HSV-2) causes genital herpes and increases the risk of acquisition and transmission of HIV. An HSV-2 vaccine is not available. We will study a replication-defective HSV-2 vaccine, HSV529, that is deleted for 2 essential viral proteins, that can infect, but not replicate in normal cells. The goals of the study are to determine (a) the safety of HSV529 vaccine in persons with or without HSV infection, and (b) the ability of the vaccine to elicit immune responses to HSV-2 including virus-specific antibodies and T cell responses to the virus. Three groups of 20 subjects each will be randomized and will receive 3 doses of HSV529 (15 subjects per group) or saline placebo injection (5 subjects per group). Each subject will be followed for 6 months after the last dose of vaccine. The 3 groups will be (a) subjects who were infected with HSV-2 in the past but may or may not have been infected with HSV-1 (HSV-1+/-/HSV-2+), (b) subjects who have been infected only with HSV-1 (HSV-1+/HSV-2-), and (c) subjects who have not been infected with HSV-1 or HSV-2 (HSV-1-/HSV-2-). Vaccine or placebo will be administered on Day 0 and approximately 1 month and 6 months after enrollment.

Eligibility

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
•1. Aged 18 to 40 years on the day of enrollment.
•2. In good general health with absence of significant health problems as determined by medical history, physical examination, and laboratory screening performed during screening visits.
•3. Subject will reside within a 60 mile or less radius from Bethesda, MD during the period of participation in the trial.
•4. 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 and IgG level greater than or equal to 600 mg/dl.
•5. Females 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 study agent.
•6. Willingness to attend all scheduled visits and able to comply with all trial procedures (e.g., blood draws, 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).
•7. Negative HIV test result determined with an approved FDA-approved test. Confirmatory testing may be required based on the initial assay used and the result.
•8. Subject is willing not to use antiviral therapy less than or equal to 2 days before and less than or equal to 3 days after each injection.
•9. 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 greater than or equal to 14 days before or greater than or equal to 14 days after administration of study vaccine, if this is felt to be necessary.
+5 more criteria

Exclusion Criteria

•Co-enrollment Guidelines: Co-enrollment in other trials is restricted, other than enrollment into observational studies or into the screening protocol. Study staff should be notified of co-enrollment as it may require the approval by the Principal Investigator.
•An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
•1. Subject is pregnant or lactating OR planning to become pregnant timeframe that begins 30 days prior to the first vaccination and ends 30 days after the third vaccination.
•2. Body Mass Index greater than 40.
•3. Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination or or planned participation during the study period up to 6 months after the last dose of vaccine or placebo. The non-interventional follow-up for an earlier study (e.g., long-term surveillance) will be allowed.
•4. Severe active infection or serious HSV-2 related or unrelated medical conditions that, in the opinion of the investigator, would prevent study completion.
•5. Subjects with 6 or more symptomatic recurrences of genital herpes disease within the year prior to Day 0.
•6. A history of HSV infection of the eye (e.g., herpes simplex interstitial keratitis or uveitis).
•7. A history of herpes gladiatorum, herpetic whitlow or eczema herpeticum.
•8. A history of lesions caused by HSV on either arm.
+21 more criteria

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Key Dates

Start Date

September 26, 2013

Primary Completion Date

March 6, 2017

Completion Date

March 6, 2017

Last Updated

March 16, 2026

Enrollment

ACTUAL participants

Conditions

Healthy Volunteers

Interventions

HSV529

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection

Inclusion Criteria

Exclusion Criteria

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