Clinical trial NCT00698568: Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prophylaxis for Herpes Simplex
Keywords: Herpes simplex, Herpes simplex candidate vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 7460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
Secondary outcomes:
measure: 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
timeFrame: On the day of each vaccination and on the following 3 days
measure: 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
timeFrame: At day -90 to day -7, and at month 7 and month 13
measure: 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
timeFrame: Day 0 through month 19
measure: To evaluate the incidence and the types of the serious adverse experiences in both groups
timeFrame: Month 7 to month 19
measure: 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
timeFrame: Before vaccination, and one month and 7 months after vaccination
measure: To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients
timeFrame: At months 7 and 13
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Middle Valley
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: San Diego
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Denver
country: United States
facility: GSK Clinical Trials Call Center
state: Colorado
city: East Lyme
country: United States
facility: GSK Clinical Trials Call Center
state: Connecticut
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Atlanta
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Indianapolis
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: Des Moines
country: United States
facility: GSK Clinical Trials Call Center
state: Iowa
city: Mission
country: United States
facility: GSK Clinical Trials Call Center
state: Kansas
city: Louisville
country: United States
facility: GSK Clinical Trials Call Center
state: Kentucky
city: Towson
country: United States
facility: GSK Clinical Trials Call Center
state: Maryland
city: Newton
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Lansing
country: United States
facility: GSK Clinical Trials Call Center
state: Michigan
city: St Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: St Louis
country: United States
facility: GSK Clinical Trials Call Center
state: Missouri
city: Omaha
country: United States
facility: GSK Clinical Trials Call Center
state: Nebraska
city: Albuquerque
country: United States
facility: GSK Clinical Trials Call Center
state: New Mexico
city: Brooklyn
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Poughkeepsie
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Cincinnati
country: United States
facility: GSK Clinical Trials Call Center
state: Ohio
city: Portland
country: United States
facility: GSK Clinical Trials Call Center
state: Oregon
city: Philadelphia
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Providence
country: United States
facility: GSK Clinical Trials Call Center
state: Rhode Island
city: Charleston
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: Austin
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Bryan
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Dallas
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Lake Jackson
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Nassau Bay
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: San Antonio
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Salt Lake City
country: United States
facility: GSK Clinical Trials Call Center
state: Utah
city: Falls Church
country: United States
facility: GSK Clinical Trials Call Center
state: Virginia
city: Seattle
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Wenatchee
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Sydney
country: Australia
facility: GSK Clinical Trials Call Center
state: New South Wales
city: Wien
country: Austria
facility: GSK Clinical Trials Call Center
city: Gent
country: Belgium
facility: GSK Clinical Trials Call Center
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Center
state: Quebec
city: Copenhagen
country: Denmark
facility: GSK Clinical Trials Call Center
city: Grenoble
country: France
facility: GSK Clinical Trials Call Center
city: München
country: Germany
facility: GSK Clinical Trials Call Center
city: Carolina
country: Puerto Rico
facility: GSK Clinical Trials Call Center
city: Pretoria
country: South Africa
facility: GSK Clinical Trials Call Center
city: Madrid
country: Spain
facility: GSK Clinical Trials Call Center
city: Basel
country: Switzerland
facility: GSK Clinical Trials Call Center
Study officials:
affiliation: GlaxoSmithKline
name: Clinical Trials
role: STUDY_DIRECTOR
References: