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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00456807

Enrollment

100

Registered

2007-04-05

Start date

2007-04-30

Completion date

2008-01-31

Last updated

2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Papillomavirus

Keywords

Human Papillomavirus

Brief 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.

Interventions

BIOLOGICALPlacebo

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

BIOLOGICALCervarix TM

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

26 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Cytokine-positive CD4/CD8 Cells Per Million in Tests Producing at Least 2 Different Cytokines	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.
Number of B-cells Per Million Showing a Specific Memory Response for HPV-16 and HPV-18	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.
Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above Pre-defined Cut-off Values	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.
Titers of Anti-HPV-16 and Anti-HPV-18 Antibodies	At Month 12 and Month 18 after first vaccination	Titers are presented as Geometric Mean Titers (GMTs).
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) Immunoglobulin G (IgG) Antibodies	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.
Correlation of Anti-HPV-16 and Anti-HPV-18 Antibodies in Serum and in Cervical Secretion (CVS) Samples	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.

Countries

Netherlands

Participant flow

Recruitment details

Subjects enrolled at pre-selected sites in the primary study HPV-015 (NCT00294047) who were in the immunogenicity subset and have received all three doses of vaccine/control were asked to participate in the present ancillary study.

Pre-assignment details

This ancillary study will consist of supplemental testing of serological and cervical samples obtained at Visit 5 (Month 12) and Visit 6 (Month 18) of the primary study HPV-015 (NCT00294047) from pre-selected sites.

Participants by arm

Arm	Count
Cervarix Group Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).	53
Placebo Group Subjects who received 3 doses of placebo during the primary study (NCT00294047).	47
Total	100

Baseline characteristics

Characteristic	Placebo Group	Total	Cervarix Group
Age, Continuous	40.3 years STANDARD_DEVIATION 8.83	40.6 years STANDARD_DEVIATION 8.63	40.9 years STANDARD_DEVIATION 8.44
Gender Female	47 Participants	100 Participants	53 Participants
Gender Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

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.