Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
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|ClinicalTrials.gov Identifier: NCT01915212|
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : May 17, 2022
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: HSV529 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||September 26, 2013|
|Actual Primary Completion Date :||March 6, 2017|
|Actual Study Completion Date :||March 6, 2017|
1 x 107 pfu/dose of HSV529 in 10 mM L-histidine buffer containing 50 mM potassium glutamate, 160 mM sodium chloride, and 10% (w/v) sucrose
The vaccine was administered intramuscularly (deltoid muscle) as a 0.5 ml solution containing 1 x 10(7) plaque forming units on day 0, one month after the first dose (day 30) and then six months after the first dose (day 180).
Placebo Comparator: Placebo
Sodium Chloride 0.9%
Sodium Chloride 0.9%
- Unsolicited adverse events [ Time Frame: After the first dose of vaccine to Day 360 ]Safety
- Solicited injection site and systemic reactions [ Time Frame: Day 0 to Day 7 after each dose and up to day 360 ]Safety
- Neutralizing antibody levels and T cell-mediated immune responses [ Time Frame: After each dose and day 360 ]Immunogenicity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915212
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Jeffrey I Cohen, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|