CompletedNCT00698490Updated Jun 17, 2008

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

A Phase 1/2 interventional study of Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 and Herpes simplex virus containing gD-Alum in Prophylaxis Herpes Simplex, sponsored by GlaxoSmithKline. Completed at 1 site in Belgium. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

Read the detailed description

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

Conditions studied

Prophylaxis Herpes Simplex

Browse trials for

Herpes Simplex 305

Keywords

Herpes simplex
Herpes simplex candidate vaccine

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 130 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 130 participants (actual)

Study arms

Experimental
Group A
HSV-seronegative subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Experimental
Group B
HSV-seropositive subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Experimental
Group C
HSV-seronegative subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Experimental
Group D
HSV-seronegative subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Experimental
Group E
HSV-seronegative subjects
Biological: Herpes simplex virus containing gD-Alum

Interventions

BiologicalAdjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
BiologicalHerpes simplex virus containing gD-Alum
Intramuscular injection, 3 doses

What researchers measure

Primary outcomes

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
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)
Time frame: After the second and third dose of each vaccine formulation
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
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

Study locations

1 site

GSK Clinical Trials Call Center
Gent, Belgium

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00698490
Lead sponsor: GlaxoSmithKline
First posted: Jun 17, 2008
Start date: Aug 1995
Primary completion: Jan 1997
Completion: Jan 1997
Last update: Jun 17, 2008

Study contacts

Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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