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

Herpes Simplex Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224471
• Other study ID #: 208141/042
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2005
• Last updated: September 20, 2016
• Start date: December 2003
• Est. completion date: January 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: January 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Biological:
• GSK208141 vaccine
3 IM doses

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Gent
Canada	GSK Investigational Site	Beauport	Quebec
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Vancouver	British Columbia
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Golden	Colorado
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-gD antibody titre in the entire cohort (10-17 yrs)		At month 7	No
Secondary	Anti-gD antibody titre		At months 2 and 12	No
Secondary	Anti-HSV neutralizing antibodies		At months 2, 7 and 12	No
Secondary	Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.		Within 7 days after each vaccination	Yes
Secondary	Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms		Within 7 days after each vaccination	Yes
Secondary	Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events		Within 30 days after any vaccination	Yes
Secondary	Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity		Throughout the study	Yes
Secondary	Occurrence and relationship to vaccination of SAEs		Throughout the study period	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No

External 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.