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Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines

Primary Purpose

Prophylaxis Herpes Simplex

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Herpes simplex virus containing gD-Alum

About this trial

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

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Between 18 and 45 years of age
Written informed consent
Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry

Exclusion Criteria:

Any previous vaccination against Herpes simplex.
Any previous administration of MPL.
Pregnancy or lactation.
Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
Clinical signs of acute or febrile illness at the time of entry into the study.
Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
Any vaccination within one week of study vaccination.
Previous known hypersensitivity to vaccination or to any component of the vaccine.
Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
Recent history of alcoholism or drug abuse (within the past 6 months).
Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

HSV-seronegative subjects

HSV-seropositive subjects

HSV-seronegative subjects

Outcomes

Primary Outcome Measures

To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)

To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies

To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)

To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms

To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies

Secondary Outcome Measures

Full Information

NCT ID

NCT00698490

First Posted

June 13, 2008

Last Updated

June 16, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00698490

Brief Title

Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines

Official Title

Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

August 1995 (undefined)

Primary Completion Date

January 1997 (Actual)

Study Completion Date

January 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.

Detailed Description

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 Herpes Simplex

Keywords

Herpes simplex, Herpes simplex candidate vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

HSV-seronegative subjects

Arm Title

Group B

Arm Type

Experimental

Arm Description

HSV-seropositive subjects

Arm Title

Group C

Arm Type

Experimental

Arm Description

HSV-seronegative subjects

Arm Title

Group D

Arm Type

Experimental

Arm Description

HSV-seronegative subjects

Arm Title

Group E

Arm Type

Experimental

Arm Description

HSV-seronegative subjects

Intervention Type

Biological

Intervention Name(s)

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Intervention Description

Intramuscular injection, 3 doses, 2 different formulations

Intervention Type

Biological

Intervention Name(s)

Herpes simplex virus containing gD-Alum

Intervention Description

Intramuscular injection, 3 doses

Primary Outcome Measure Information:

Title

To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)

Time Frame

After the second and third doses of each vaccine

Title

To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies

Title

To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)

Time Frame

After the second and third dose of each vaccine formulation

Title

To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms

Time Frame

During 3 days after each dose of each vaccine

Title

To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies

Time Frame

After 2 and 3 doses of vaccines

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between 18 and 45 years of age Written informed consent Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry Exclusion Criteria: Any previous vaccination against Herpes simplex. Any previous administration of MPL. Pregnancy or lactation. Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Clinical signs of acute or febrile illness at the time of entry into the study. Any administration of immunoglobulins during the vaccination course or within one month of vaccination. Any vaccination within one week of study vaccination. Previous known hypersensitivity to vaccination or to any component of the vaccine. Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included. Recent history of alcoholism or drug abuse (within the past 6 months). Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.

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

Gent

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines

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