Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection (NCT01915212) | Clinical Trial Compass
CompletedPhase 1
Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
United States69 participantsStarted 2013-09-26
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 40 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.
✓. Subject will reside within a 60 mile or less radius from Bethesda, MD during the period of participation in the trial.
✓. 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.
✓. 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.
✓. 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).
What they're measuring
1
Unsolicited adverse events
Timeframe: After the first dose of vaccine to Day 360
2
Solicited injection site and systemic reactions
Timeframe: Day 0 to Day 7 after each dose and up to day 360
Trial details
NCT IDNCT01915212
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✓. 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.
✓. 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.
Exclusion criteria
✕. 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.
✕. Body Mass Index greater than 40.
✕. 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.
✕. 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 6 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.