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OpenTrials
Completed

NCT Number: NCT00697567

Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

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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–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

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 40 years of age
  • Written informed consent
  • Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
  • Good clinical condition as evidenced by history taking and physical examination

Exclusion criteria

  • History of persistent hepatic, renal, cardiac or respiratory diseases.
  • Clinical signs of acute illness at the time of entry into the study.
  • Seropositive for antibodies against the human immunodeficiency virus (HIV).
  • Pregnancy, lactation.
  • Treatment with corticosteroids or immunomodulating drugs.
  • Simultaneous participation in another clinical trial.
  • Any previous history of allergy.
  • Any concomitant vaccination or administration of immunoglobulin during the study period.
  • Any abnormal laboratory value among the tests performed at screening

Treatment and study plan

Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

Biological

Intramuscular injection, 3 doses

Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

Biological

Intramuscular injection, 3 doses

Primary outcomes

  1. To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers

    Time frame: Days 0, 30, 60, 180 and 365 after vaccination

  2. To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers

    Time frame: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant

Important dates

Study start
1992
Primary completion
1997
Study completion
1997
First posted
Jun 16, 2008
Registry last updated
Jun 16, 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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