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

September 21, 2005
September 29, 2011
December 2003
January 2006   (final data collection date for primary outcome measure)
Anti-gD antibody titre in the entire cohort (10-17 yrs) [ Time Frame: At month 7 ] [ Designated as safety issue: No ]
Anti-gD antibody titre assessed at M7 in the entire cohort (10–17 yrs)
Complete list of historical versions of study NCT00224471 on ClinicalTrials.gov Archive Site
  • 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 ]
Anti-gD antibody titre at M2 and M12; anti-HSV neutralizing antibodies at months 2,7 and 12; solicited general and local symptoms within 7days after vaccination; unsolicited symptoms within 30days after vaccination; SAEs over study period.
Not Provided
Not Provided
 
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Herpes Simplex
Biological: GSK208141 vaccine
3 IM doses
Other Name: Herpes simplex vaccine
  • Experimental: Group A
    Intervention: Biological: GSK208141 vaccine
  • Experimental: Group B
    Intervention: Biological: GSK208141 vaccine
  • Experimental: Group C
    Intervention: Biological: GSK208141 vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
671
January 2006
January 2006   (final data collection date for primary outcome measure)

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.
Female
10 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada
 
NCT00224471
208141/042
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP