Last updated: 09/22/2020 09:20:05

Study to compare safety and immunogenicity of commercial scale consistency lots of herpes simplex vaccine

GSK study ID
208141/042
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Anti-gD antibody titre in the entire cohort (10–17 yrs)

Timeframe: At month 7

Secondary outcomes:

Anti-gD antibody titre

Timeframe: At months 2 and 12

Anti-HSV neutralizing antibodies

Timeframe: At months 2, 7 and 12

Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.

Timeframe: Within 7 days after each vaccination

Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms

Timeframe: Within 7 days after each vaccination

Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events

Timeframe: 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

Timeframe: Throughout the study

Occurrence and relationship to vaccination of SAEs

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: At months 0, 2, 7, and 12

Interventions:
Biological/vaccine: GSK208141 vaccine
Enrollment:
671
Observational study model:
Not applicable
Primary completion date:
2005-07-09
Time perspective:
Not applicable
Clinical publications:
Leroux-Roels G et al. (2013) Clinical evaluation to confirm the manufacturing consistency of three lots of an adjuvanted glycoprotein D genital herpes vaccine in healthy seronegative pre-teen and adolescent girls: A phase III multi-center double-blind randomized trial. Trials in Vaccinology. NA(2):10-18.
Medical condition
Herpes Simplex
Product
SB208141
Collaborators
Not applicable
Study date(s)
December 2003 to January 2006
Type
Interventional
Phase
3

Participation criteria

Sex
Female
Age
10 - 17 years
Accepts healthy volunteers
Yes
  • 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
  • Pregnant or lactating female.
  • Female planning to become pregnant during the first eight months of the study

Trial location(s)

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

Study documents

Protocol
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2005-07-09
Actual study completion date
2006-11-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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