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OpenTrials
Completed

NCT Number: NCT00698893

Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults

The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.

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Key information

Conditions

Herpes Simplex DNA Virus Infections 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 1

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
  • Seropositive for antibodies against HSV
  • Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
  • Good physical condition as established by physical examination and history taking at the time of entry

Exclusion criteria

  • Any abnormal laboratory value among the tests performed at screening.
  • History of persistent hepatic, renal, cardiac or respiratory diseases
  • Clinical signs of acute illness at the time of entry into the study.
  • Previous history of asthma or hypersensitivity to drugs.
  • Seropositive for antibodies against the human immunodeficiency virus
  • Pregnancy and lactation.
  • Treatment with corticosteroids or immunomodulating drugs.
  • Simultaneous participation in another clinical trial.
  • Administration of any other vaccine or immunoglobulins during the study period

Treatment and study plan

Herpes simplex candidate (gD) vaccine GSK208141

Biological

Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Primary outcomes

  1. To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms

    Time frame: Throughout the study

  2. Measurement of haematology/biochemical parameters on blood samples

    Time frame: Throughout the study

  3. Vaccine reactogenicity by soliciting of local and general signs/symptoms

    Time frame: On the day of vaccination and the subsequent 7 days

  4. Vaccine immunogenicity by 6 measurements of anti-HSV antibodies

    Time frame: From day 0 to day 45 following vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL

Important dates

Study start
1992
Primary completion
1992
Study completion
1992
First posted
Jun 17, 2008
Registry last updated
Jun 2, 2017

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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