Clincosm LogoSign in Get a demo

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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00698568
Collaborator
(none)
7,460
Enrollment
47
Locations
2
Arms
30
Duration (Months)
158.7
Patients Per Site
5.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141
  • Biological: Placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
7460 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Oct 1, 1996
Actual Primary Completion Date :
Apr 1, 1999
Actual Study Completion Date :
Apr 1, 1999

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intramuscular injection, 3 doses
Placebo Comparator: Group B

Biological: Placebo
Intramuscular injection, 3 doses

Outcome Measures

Primary Outcome Measures

  1. 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 [During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)]

Secondary Outcome Measures

  1. 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 [On the day of each vaccination and on the following 3 days]

  2. 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 [At day -90 to day -7, and at month 7 and month 13]

  3. 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 [Day 0 through month 19]

  4. To evaluate the incidence and the types of the serious adverse experiences in both groups [Month 7 to month 19]

  5. 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 [Before vaccination, and one month and 7 months after vaccination]

  6. To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients [At months 7 and 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Clinical Trials Call Center La Jolla California United States 92037
2 GSK Clinical Trials Call Center Middle Valley California United States 94941
3 GSK Clinical Trials Call Center San Diego California United States 92128
4 GSK Clinical Trials Call Center Denver Colorado United States 80262
5 GSK Clinical Trials Call Center East Lyme Connecticut United States 06333
6 GSK Clinical Trials Call Center Atlanta Georgia United States 30033
7 GSK Clinical Trials Call Center Atlanta Georgia United States 30342
8 GSK Clinical Trials Call Center Indianapolis Indiana United States 46202-5124
9 GSK Clinical Trials Call Center Des Moines Iowa United States 50309
10 GSK Clinical Trials Call Center Mission Kansas United States 66202
11 GSK Clinical Trials Call Center Louisville Kentucky United States 40292
12 GSK Clinical Trials Call Center Towson Maryland United States 21286
13 GSK Clinical Trials Call Center Newton Massachusetts United States 02165
14 GSK Clinical Trials Call Center Lansing Michigan United States 48824
15 GSK Clinical Trials Call Center St Louis Missouri United States 63139
16 GSK Clinical Trials Call Center St Louis Missouri United States 63141
17 GSK Clinical Trials Call Center Omaha Nebraska United States 68131
18 GSK Clinical Trials Call Center Albuquerque New Mexico United States 87108
19 GSK Clinical Trials Call Center Brooklyn New York United States 11203
20 GSK Clinical Trials Call Center Poughkeepsie New York United States 12601
21 GSK Clinical Trials Call Center Cincinnati Ohio United States 45229-3039
22 GSK Clinical Trials Call Center Portland Oregon United States 97210
23 GSK Clinical Trials Call Center Philadelphia Pennsylvania United States 19104
24 GSK Clinical Trials Call Center Pittsburgh Pennsylvania United States 45241
25 GSK Clinical Trials Call Center Providence Rhode Island United States 02907
26 GSK Clinical Trials Call Center Charleston South Carolina United States 29425-3312
27 GSK Clinical Trials Call Center Austin Texas United States 78758
28 GSK Clinical Trials Call Center Bryan Texas United States 77802
29 GSK Clinical Trials Call Center Dallas Texas United States 75235-8889
30 GSK Clinical Trials Call Center Lake Jackson Texas United States 77566
31 GSK Clinical Trials Call Center Nassau Bay Texas United States 77058
32 GSK Clinical Trials Call Center San Antonio Texas United States 78229
33 GSK Clinical Trials Call Center Salt Lake City Utah United States 84132
34 GSK Clinical Trials Call Center Falls Church Virginia United States 22046
35 GSK Clinical Trials Call Center Seattle Washington United States 98104
36 GSK Clinical Trials Call Center Wenatchee Washington United States 98801
37 GSK Clinical Trials Call Center Sydney New South Wales Australia 2000
38 GSK Clinical Trials Call Center Wien Austria
39 GSK Clinical Trials Call Center Gent Belgium
40 GSK Clinical Trials Call Center Montreal Quebec Canada H2L 4C7
41 GSK Clinical Trials Call Center Copenhagen Denmark
42 GSK Clinical Trials Call Center Grenoble France
43 GSK Clinical Trials Call Center München Germany
44 GSK Clinical Trials Call Center Carolina Puerto Rico 00984
45 GSK Clinical Trials Call Center Pretoria South Africa
46 GSK Clinical Trials Call Center Madrid Spain
47 GSK Clinical Trials Call Center Basel Switzerland

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00698568
Other Study ID Numbers:
  • 208141/016
First Posted:
Jun 17, 2008
Last Update Posted:
Jun 17, 2008
Last Verified:
Jun 1, 2008
Keywords provided by , ,
Herpes simplex, Herpes simplex candidate vaccine
Additional relevant MeSH terms:
Herpes Simplex

Study Results

No Results Posted as of Jun 17, 2008