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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00698568




Registration number
NCT00698568
Ethics application status
Date submitted
16/06/2008
Date registered
17/06/2008
Date last updated
17/06/2008

Titles & IDs
Public title
Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
Scientific 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
Secondary ID [1] 0 0
208141/016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylaxis for Herpes Simplex 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Herpes simplex candidate vaccine- adjuvanted GSK 208141
Other interventions - Placebo

Experimental: Group A -

Placebo Comparator: Group B -


Other interventions: Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intramuscular injection, 3 doses

Other interventions: Placebo
Intramuscular injection, 3 doses
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
On the day of each vaccination and on the following 3 days
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
At day -90 to day -7, and at month 7 and month 13
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 0 through month 19
Secondary outcome [4] 0 0
To evaluate the incidence and the types of the serious adverse experiences in both groups
Timepoint [4] 0 0
Month 7 to month 19
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Before vaccination, and one month and 7 months after vaccination
Secondary outcome [6] 0 0
To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients
Timepoint [6] 0 0
At months 7 and 13

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/1999
Sample size
Target
Accrual to date
Final
7460
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Clinical Trials Call Center - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Rhode Island
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Gent
Country [27] 0 0
Canada
State/province [27] 0 0
Quebec
Country [28] 0 0
Denmark
State/province [28] 0 0
Copenhagen
Country [29] 0 0
France
State/province [29] 0 0
Grenoble
Country [30] 0 0
Germany
State/province [30] 0 0
München
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Carolina
Country [32] 0 0
South Africa
State/province [32] 0 0
Pretoria
Country [33] 0 0
Spain
State/province [33] 0 0
Madrid
Country [34] 0 0
Switzerland
State/province [34] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00698568
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00698568