Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
- 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.
- To test whether a new herpes vaccine is safe.
- Healthy adults 18 40 years old.
- 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.
Herpes Simplex Virus
Herpes Simplex Virus Vaccines
Procedure: Blood Draw
Procedure: Clinical evaluation of herpes simplex diseases
Procedure: Self swabbing for asymptomatic viral shedding
Procedure: Collection of cervicovaginal secretions
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Phase I Study of the Safety of Replication-Defective Herpes Simplex Virus-2 Vaccine, HSV529, in Adults Aged 18 to 40 Years With or Without HSV Infection|
- Solicited injection site and systemic reactions days 0-7; unsolicited injection site reactions, systemic AEs, and SAEs entire study duration, anaphylaxis in first 30 minutes after vaccination [ Time Frame: day 0 to day 360 plus or minus 30 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
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.
|Contact: Doreen L Garabedian, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Lesia K Dropulic, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|