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

NCT01915212 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

HSV529

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).

OTHER

Placebo

Sodium Chloride 0.9%

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jeffrey I Cohen, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-26
Primary Completion
2017-03-06
Completion
2017-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01915212 on ClinicalTrials.gov