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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00698893
Collaborator
(none)
16
Enrollment
2
Arms
2
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Herpes simplex candidate (gD) vaccine GSK208141
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
May 1, 1992
Actual Primary Completion Date :
Jul 1, 1992
Actual Study Completion Date :
Jul 1, 1992

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Biological: Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
Experimental: Group B

Biological: Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Outcome Measures

Primary Outcome Measures

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

  2. Measurement of haematology/biochemical parameters on blood samples [Throughout the study]

  3. Vaccine reactogenicity by soliciting of local and general signs/symptoms [On the day of vaccination and the subsequent 7 days]

  4. Vaccine immunogenicity by 6 measurements of anti-HSV antibodies [From day 0 to day 45 following vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00698893
Other Study ID Numbers:
  • 208141/001
First Posted:
Jun 17, 2008
Last Update Posted:
Jun 2, 2017
Last Verified:
Jun 1, 2017
Keywords provided by GlaxoSmithKline
Herpes simplex
Herpes simplex candidate (gD) vaccine
Additional relevant MeSH terms:
Herpes Simplex

Study Results

No Results Posted as of Jun 2, 2017