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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT01915212

Public ClinicalTrials.gov record NCT01915212. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 7:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01915212
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
69 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years to 40 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 25, 2013
Primary completion
Mar 5, 2017
Completion
Mar 5, 2017
Last update posted
Aug 31, 2026

2013 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
National Institutes of Health Clinical Center Bethesda Maryland 20892

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01915212, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2026 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01915212 live on ClinicalTrials.gov.

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