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Completed

NCT Number: NCT00456807

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

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.

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Key information

Conditions

Infections, Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

26 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Amsterdam, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Biological

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Cervarix TM

Biological

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Other names: GSK Biologicals' HPV-16/18 VLP/AS04 vaccine

Primary outcomes

  1. Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines

    Time frame: At Month 12 and Month 18 after first vaccination

    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.

  2. Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18

    Time frame: At Month 12 and Month 18 after first vaccination

    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.

  3. Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values

    Time frame: At Month 12 and Month 18 after first vaccination

    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.

  4. Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies

    Time frame: At Month 12 and Month 18 after first vaccination

    Titers are presented as Geometric Mean Titers (GMTs).

  5. Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies

    Time frame: At Month 12 and Month 18 after first vaccination

    Titers given as Geometric Mean Titers (GMTs). An arbitrary value of 0 was given for subjects with antibody concentration below the limit of quantification.

  6. Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples

    Time frame: At Month 12 and Month 18 after first vaccination

    Pearson coefficients of correlation between serum and CVS for anti-HPV-16 and anti-HPV-18 titers standardized for total IgG were calculated.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 5, 2007
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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