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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00224471
First received: September 21, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Herpes Simplex
Biological: GSK208141 vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study to Compare Immunogenicity & Safety of 3 Comercial Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 & -2 Seronegative (HSV 1-/2-) Females of 10-17 y & Vaccine Immunogenicity in Healthy HSV 1-/2- Females of 10-17 y With Healthy HSV 1-/2- Adult Females

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-gD antibody titre in the entire cohort (10-17 yrs) [ Time Frame: At month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-gD antibody titre [ Time Frame: At months 2 and 12 ] [ Designated as safety issue: No ]
  • Anti-HSV neutralizing antibodies [ Time Frame: At months 2, 7 and 12 ] [ Designated as safety issue: No ]
  • Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated. [ Time Frame: Within 7 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms [ Time Frame: Within 7 days after each vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events [ Time Frame: Within 30 days after any vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Occurrence and relationship to vaccination of SAEs [ Time Frame: Throughout the study period ] [ Designated as safety issue: Yes ]
  • Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039 [ Time Frame: At month 7 ] [ Designated as safety issue: No ]
  • Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039 [ Time Frame: At month 7 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At months 0, 2, 7, and 12 ] [ Designated as safety issue: No ]

Enrollment: 671
Study Start Date: December 2003
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: GSK208141 vaccine
3 IM doses
Other Name: Herpes simplex vaccine
Experimental: Group B Biological: GSK208141 vaccine
3 IM doses
Other Name: Herpes simplex vaccine
Experimental: Group C Biological: GSK208141 vaccine
3 IM doses
Other Name: Herpes simplex 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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224471

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00224471     History of Changes
Other Study ID Numbers: 208141/042
Study First Received: September 21, 2005
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Adolescents
Immunogenicity
Safety
Herpes Simplex vaccine

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on October 19, 2014