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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698490

Enrollment

130

Registered

2008-06-17

Start date

1995-08-31

Completion date

1997-01-31

Last updated

2008-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis Herpes Simplex

Keywords

Herpes simplex, Herpes simplex candidate vaccine

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

* 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.

Design outcomes

Primary

Measure	Time frame
To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)	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)	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	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	After 2 and 3 doses of vaccines

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026