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Completed

NCT Number: NCT00698490

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

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.

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Key information

Conditions

Prophylaxis Herpes Simplex DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GSK Clinical Trials Call Center

Ghent, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141

Biological

Intramuscular injection, 3 doses, 2 different formulations

Herpes simplex virus containing gD-Alum

Biological

Intramuscular injection, 3 doses

Primary outcomes

  1. 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

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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
1995
Primary completion
1997
Study completion
1997
First posted
Jun 17, 2008
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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