Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

Papillomavirus Vaccines Clinical Trial

Official title:

Complementary Testing to Further Evaluate the Immunogenicity of a GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Aged Over 26 Years Enrolled in Study 104820.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00456807
• Other study ID #: 109801
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2007
• Last updated: March 17, 2011
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 26 Years and older

Eligibility

Inclusion Criteria:

• A female enrolled in study 104820 and who received three doses of study vaccine/control.

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

• Written informed consent obtained from the subject prior to enrolment in this ancillary study.

Exclusion Criteria:

• Pregnancy.

• Administration of any HPV vaccine other than that foreseen by the study protocol.

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.

• Chronic administration of immunosuppressants or other immune-modifying drugs since study start.

• Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.

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

• Cervical Neoplasia
• Human Papillomavirus (HPV) Infection
• Papillomavirus Vaccines

Intervention

Biological:
• Placebo
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
• Cervarix TM
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Delft

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines	The geometric mean and 95% confidence interval of the number of Human Papilloma Virus type 16 (HPV-16) and HPV-18 specific CD4 and CD8 cells producing at least 2 different cytokines is reported per million of CD4 or CD8 T-cells, respectively.	At Month 12 and Month 18 after first vaccination	No
Primary	Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18	The geometric mean and 95% confidence interval of the number of HPV-16 and HPV-18 specific memory B-cells is reported per million of B-cells.; An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.	At Month 12 and Month 18 after first vaccination	No
Primary	Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values	Cut-off values assessed include 8 enzyme-linked immunosorbent assay units Per Milliliter (EL.U/mL)for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.	At Month 12 and Month 18 after first vaccination	No
Primary	Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies	Titers are presented as Geometric Mean Titers (GMTs).	At Month 12 and Month 18 after first vaccination	No
Primary	Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies	Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.	At Month 12 and Month 18 after first vaccination	No
Primary	Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples	Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.	At Month 12 and Month 18 after first vaccination	No