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Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

Primary Purpose

Prophylaxis for Herpes Simplex

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Herpes simplex candidate vaccine- adjuvanted GSK 208141
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prophylaxis for Herpes Simplex focused on measuring Herpes simplex, Herpes simplex candidate vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age and over at the time of first vaccination
  • Written informed consent
  • Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control

Exclusion Criteria:

  • Any previous history of or current clinical signs or symptoms of genital herpes disease.
  • Any previous vaccination against herpes simplex.
  • Any previous administration of MPL.
  • History of herpetic keratitis.
  • History of erythema multiforme.
  • Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose
  • Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
  • HIV positive at the time of enrollment
  • Clinical signs of acute or febrile illness at the time of entry into the study.
  • Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
  • Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
  • Any vaccine administration less than one week before or after a study vaccination.
  • Previous known hypersensitivity to vaccination or to any component of the vaccine.
  • Simultaneous participation in any other clinical trial of an investigational drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
  • Recent history of alcoholism or drug abuse
  • Recent clinical history or evidence of significant hepatic disease
  • History of a current acute or chronic auto immune disease.
  • Recent clinical history or evidence of renal dysfunction
  • Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
  • Inability or unwillingness to comply with the protocol or not expected to complete the study period

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences

Secondary Outcome Measures

To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms
To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country
To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes
To evaluate the incidence and the types of the serious adverse experiences in both groups
To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups
To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients

Full Information

First Posted
June 16, 2008
Last Updated
June 16, 2008
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00698568
Brief Title
Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
Official Title
Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 1996 (undefined)
Primary Completion Date
April 1999 (Actual)
Study Completion Date
April 1999 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.
Detailed Description
This study was monitored by a Data Safety Monitoring Board. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prophylaxis for Herpes Simplex
Keywords
Herpes simplex, Herpes simplex candidate vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intervention Description
Intramuscular injection, 3 doses
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection, 3 doses
Primary Outcome Measure Information:
Title
To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences
Time Frame
During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
Secondary Outcome Measure Information:
Title
To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms
Time Frame
On the day of each vaccination and on the following 3 days
Title
To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country
Time Frame
At day -90 to day -7, and at month 7 and month 13
Title
To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes
Time Frame
Day 0 through month 19
Title
To evaluate the incidence and the types of the serious adverse experiences in both groups
Time Frame
Month 7 to month 19
Title
To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups
Time Frame
Before vaccination, and one month and 7 months after vaccination
Title
To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients
Time Frame
At months 7 and 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age and over at the time of first vaccination Written informed consent Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control Exclusion Criteria: Any previous history of or current clinical signs or symptoms of genital herpes disease. Any previous vaccination against herpes simplex. Any previous administration of MPL. History of herpetic keratitis. History of erythema multiforme. Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed. HIV positive at the time of enrollment Clinical signs of acute or febrile illness at the time of entry into the study. Any continuous suppressive antiviral oral therapy within the 6 months prior to entry. Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination. Any vaccine administration less than one week before or after a study vaccination. Previous known hypersensitivity to vaccination or to any component of the vaccine. Simultaneous participation in any other clinical trial of an investigational drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug Recent history of alcoholism or drug abuse Recent clinical history or evidence of significant hepatic disease History of a current acute or chronic auto immune disease. Recent clinical history or evidence of renal dysfunction Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study. Inability or unwillingness to comply with the protocol or not expected to complete the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Middle Valley
State/Province
California
ZIP/Postal Code
94941
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
East Lyme
State/Province
Connecticut
ZIP/Postal Code
06333
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5124
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02165
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
45241
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02907
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-3312
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-8889
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
GSK Clinical Trials Call Center
City
Wien
Country
Austria
Facility Name
GSK Clinical Trials Call Center
City
Gent
Country
Belgium
Facility Name
GSK Clinical Trials Call Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4C7
Country
Canada
Facility Name
GSK Clinical Trials Call Center
City
Copenhagen
Country
Denmark
Facility Name
GSK Clinical Trials Call Center
City
Grenoble
Country
France
Facility Name
GSK Clinical Trials Call Center
City
München
Country
Germany
Facility Name
GSK Clinical Trials Call Center
City
Carolina
ZIP/Postal Code
00984
Country
Puerto Rico
Facility Name
GSK Clinical Trials Call Center
City
Pretoria
Country
South Africa
Facility Name
GSK Clinical Trials Call Center
City
Madrid
Country
Spain
Facility Name
GSK Clinical Trials Call Center
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

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