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

NCT ID: NCT00698490

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Study Completion Date

1997-01-31

Brief Summary

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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

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At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.

Conditions

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Prophylaxis Herpes Simplex

Keywords

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Herpes simplex Herpes simplex candidate vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group A

HSV-seronegative subjects

Group Type EXPERIMENTAL

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses, 2 different formulations

Group B

HSV-seropositive subjects

Group Type EXPERIMENTAL

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses, 2 different formulations

Group C

HSV-seronegative subjects

Group Type EXPERIMENTAL

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses, 2 different formulations

Group D

HSV-seronegative subjects

Group Type EXPERIMENTAL

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses, 2 different formulations

Group E

HSV-seronegative subjects

Group Type EXPERIMENTAL

Herpes simplex virus containing gD-Alum

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

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Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Intramuscular injection, 3 doses, 2 different formulations

Intervention Type BIOLOGICAL

Herpes simplex virus containing gD-Alum

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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208141/015

Identifier Type: -

Identifier Source: org_study_id