Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
NCT00698568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7460
Last updated 2008-06-17
Summary
This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.
Conditions
- Prophylaxis for Herpes Simplex
Interventions
- BIOLOGICAL
-
Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intramuscular injection, 3 doses
- BIOLOGICAL
-
Intramuscular injection, 3 doses
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1996-10-31
- Primary Completion
- 1999-04-30
- Completion
- 1999-04-30
Countries
- United States
- Australia
- Austria
- Belgium
- Canada
- Denmark
- France
- Germany
- Puerto Rico
- South Africa
- Spain
- Switzerland
Study Locations
More Related Trials
-
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
NCT00224471 ·Status: COMPLETED ·Phase: PHASE3
-
Study of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
NCT01915212 ·Status: COMPLETED ·Phase: PHASE1
-
HerpeVac Trial for Young Women
NCT00057330 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
NCT02515175 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
NCT02114060 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
NCT02837575 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
NCT02030301 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
NCT04222985 ·Status: TERMINATED ·Phase: PHASE1
-
A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
NCT04762511 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Immunogenicity Study of Therapeutic HSV-2 Vaccine
NCT01667341 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
NCT01827839 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
NCT05432583 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Herpevac Neonatal Substudy
NCT00138320 ·Status: TERMINATED
-
Long-term Follow-up of GEN-003-002 Subjects for Efficacy and Immunogenicity
NCT02910284 ·Status: COMPLETED
-
A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years
NCT05989672 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
NCT00375570 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
NCT06569823 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
NCT02300142 ·Status: COMPLETED ·Phase: PHASE2
-
A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
NCT05298254 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
NCT00158860 ·Status: COMPLETED ·Phase: PHASE4
-
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
NCT01687595 ·Status: COMPLETED ·Phase: PHASE2
-
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
NCT03146403 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster
NCT04091451 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2
NCT00274300 ·Status: COMPLETED ·Phase: PHASE1
-
Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
NCT00946556 ·Status: COMPLETED ·Phase: NA