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Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

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ClinicalTrials.gov Identifier: NCT00698568
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 16, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date June 17, 2008
Study Start Date  ICMJE October 1996
Actual Primary Completion Date April 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences [ Time Frame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms [ Time Frame: On the day of each vaccination and on the following 3 days ]
  • To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country [ Time Frame: At day -90 to day -7, and at month 7 and month 13 ]
  • To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes [ Time Frame: Day 0 through month 19 ]
  • To evaluate the incidence and the types of the serious adverse experiences in both groups [ Time Frame: Month 7 to month 19 ]
  • To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups [ Time Frame: Before vaccination, and one month and 7 months after vaccination ]
  • To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients [ Time Frame: At months 7 and 13 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
Official Title  ICMJE Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease
Brief Summary This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.
Detailed Description This study was monitored by a Data Safety Monitoring Board. At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Prophylaxis for Herpes Simplex
Intervention  ICMJE
  • Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141
    Intramuscular injection, 3 doses
  • Biological: Placebo
    Intramuscular injection, 3 doses
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141
  • Placebo Comparator: Group B
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2008)
7460
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1999
Actual Primary Completion Date April 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age and over at the time of first vaccination
  • Written informed consent
  • Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control

Exclusion Criteria:

  • Any previous history of or current clinical signs or symptoms of genital herpes disease.
  • Any previous vaccination against herpes simplex.
  • Any previous administration of MPL.
  • History of herpetic keratitis.
  • History of erythema multiforme.
  • Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose
  • Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
  • HIV positive at the time of enrollment
  • Clinical signs of acute or febrile illness at the time of entry into the study.
  • Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
  • Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
  • Any vaccine administration less than one week before or after a study vaccination.
  • Previous known hypersensitivity to vaccination or to any component of the vaccine.
  • Simultaneous participation in any other clinical trial of an investigational drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
  • Recent history of alcoholism or drug abuse
  • Recent clinical history or evidence of significant hepatic disease
  • History of a current acute or chronic auto immune disease.
  • Recent clinical history or evidence of renal dysfunction
  • Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
  • Inability or unwillingness to comply with the protocol or not expected to complete the study period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Puerto Rico,   South Africa,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698568
Other Study ID Numbers  ICMJE 208141/016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabelle Harpigny, GSK
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP