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

Prophylaxis Herpes Simplex Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698490
• Other study ID #: 208141/015
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 13, 2008
• Last updated: June 16, 2008
• Start date: August 1995
• Est. completion date: January 1997

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 1997
• Est. primary completion date: January 1997
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Simplex
• Prophylaxis Herpes Simplex

Intervention

Biological:
• Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
• Herpes simplex virus containing gD-Alum
Intramuscular injection, 3 doses

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
Primary	To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and ? interferon)		After the second and third dose of each vaccine formulation
Primary	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
Primary	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