Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine

A Phase III, Double-blind, Randomized, Study to Compare: 1) the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative (HSV 1-/2-) Female Subjects Aged 10 - 17 Years, and 2) Vaccine Immunogenicity in Healthy HSV 1-/2- Females Aged 10 - 17 Years With Healthy HSV 1-/2- Adult Females

Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.

Study Overview

• Status: Completed
• Conditions: Herpes Simplex
• Intervention / Treatment: Biological: GSK208141 vaccine

Detailed Description

At month 0, 1 and 6, 3 groups of 184 subjects received each 3 doses of herpes simplex vaccine lot A, B or C, respectively. The study took 14 months to complete, including screening, and 6 visits were required. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

• Study Type: Interventional
• Enrollment (Actual): 671
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • GSK Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • GSK Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • GSK Investigational Site
  • Quebec
    • Beauport, Quebec, Canada, G1E 7G9
      • GSK Investigational Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85201
      • GSK Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • GSK Investigational Site
  • Colorado
    • Golden, Colorado, United States, 80401
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • GSK Investigational Site
  • Texas
    • Galveston, Texas, United States, 77555-0188
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • GSK Investigational Site
    • Salt Lake City, Utah, United States, 84121
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
• Seronegative for HSV-1 and HSV-2 at screening
• Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
• Subject must have a negative urine pregnancy test.
• Subject must be of non-childbearing potential, i.e. pre-menarcheal, or if of childbearing potential she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
• A subject who (or whose parents/guardian) the investigator believes can and will comply with the requirements of the protocol

Exclusion criteria:

• Pregnant or lactating female.
• Female planning to become pregnant during the first eight months of the study
• Any previous history of, or current clinical signs or symptoms of oro-labial (cold sores), genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling, or dysuria.
• Previous vaccination against herpes.
• History of erythema multiforme.
• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Planned administration/administration of a non-study vaccine within 30 days before and after the first dose of study vaccine with the following exceptions: Administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus containing vaccine up to 8 days before the first dose of study vaccine is allowed.
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of a current acute or chronic autoimmune disease.
• History of any neurologic disorders or seizures, with the exception of a single febrile seizure during childhood.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
• Acute disease at the time of enrolment
• Oral temperature ≥99.5°F (> 37.5°C) / axillary temperature ≥99.5°F (> 37.5°C) at the time of enrolment
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned use during the study period
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: GSK208141 vaccine; 3 IM doses; Other Names: Herpes simplex vaccine
Experimental: Group B	Biological: GSK208141 vaccine; 3 IM doses; Other Names: Herpes simplex vaccine
Experimental: Group C	Biological: GSK208141 vaccine; 3 IM doses; Other Names: Herpes simplex vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-gD antibody titre in the entire cohort (10-17 yrs)	At month 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Anti-gD antibody titre	At months 2 and 12
Anti-HSV neutralizing antibodies	At months 2, 7 and 12
Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.	Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms	Within 7 days after each vaccination
Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events	Within 30 days after any vaccination
Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity	Throughout the study
Occurrence and relationship to vaccination of SAEs	Throughout the study period
Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039	At month 7
Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039	At month 7
In the event that a cell-mediated immune correlate of protection is identified in study 208141/039: assessment of the immune correlate of protection in a random subset of HBV-042 subjects	At months 0, 2, 7, and 12

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: September 21, 2005
• First Submitted That Met QC Criteria: September 21, 2005
• First Posted (Estimate): September 23, 2005

Study Record Updates

• Last Update Posted (Estimate): September 21, 2016
• Last Update Submitted That Met QC Criteria: September 20, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Adolescents; Safety; Immunogenicity; Herpes Simplex vaccine
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 208141/042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: 208141/042
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 208141/042
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 208141/042
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Statistical Analysis Plan
   Information identifier: 208141/042
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 208141/042
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 208141/042
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No