Clinical trial NCT00546078: Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Official title: Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Papillomavirus
Keywords: HPV vaccine
Cervical cancer
Human papillomavirus infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 116
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study.

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


Eligibility criteria: Inclusion Criteria:

* A subject whom the investigator believes that she can and will comply with the requirements of the protocol
* Must have received three doses of study vaccine or placebo control in study 580299/001.
* Must have completed study 580299/007.
* Written informed consent must be obtained from the subject prior to enrollment in the study.
* Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
* Subject must have a negative urine pregnancy test.
* Subject must be at least three months post-termination of a pregnancy.
* Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

* Pregnant or breastfeeding.
* A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
* Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
* previous administration of components of the investigational vaccine outside of protocol 580299/001.
* Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
* Hypersensitivity to latex
* Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Cancer or autoimmune disease under treatment.
* Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
* Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
* Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.

Primary outcomes:
measure: Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
timeFrame: At Day 7 and Month 1 (Day 30)
measure: Anti-HPV-16 and Anti-HPV-18 Antibody Titers
timeFrame: At Day 7 and at Month 1 (Day 30)
Secondary outcomes:
measure: Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values
timeFrame: At Month 7 and Month 18
measure: Anti-HPV-16 and Anti-HPV-18 Antibody Titers
timeFrame: At Month 7 and Month 18
measure: Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL
timeFrame: Day 0, Month 1 (Day 30), Month 7 and Month 18
measure: Anti-HPV-31 and Anti-HPV-45 Antibody Titers
timeFrame: Day 7, Month 1 (Day 30), Month 7 and Month 18
measure: Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
timeFrame: Day 0, Month 1 [Day 30], Month 7 and Month 18
measure: Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
timeFrame: Day 0, Month 1 [Day 30], Month 7 and Month 18
measure: Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types
timeFrame: Day 0, Month 1 [Day 30], Month 7 and Month 18
measure: Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples
timeFrame: Day 0, Month 1 (Day 30), Month 7 and Month 18
measure: Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples
timeFrame: Day 0, Month 1 (Day 30), Month 7 and Month 18
measure: Number of Subjects Reporting Solicited Local Symptoms
timeFrame: Within 7 days after vaccination
measure: Number of Subjects Reporting Solicited General Symptoms
timeFrame: Within 7 days of vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events (AE)
timeFrame: Within 30 days of vaccination
measure: Outcome of Any Reported Pregnancies
timeFrame: From Day 0 up to Month 18
measure: Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)
timeFrame: From Day 0 up to Month 18
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: From Day 0 up to Month 18
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Bardstown
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Grove City
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Seattle
country: United States
facility: GSK Investigational Site
state: Washington
city: Marshfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Langley
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Moscicki AB, Wheeler CM, Romanowski B, Hedrick J, Gall S, Ferris D, Poncelet S, Zahaf T, Moris P, Geeraerts B, Descamps D, Schuind A. Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women. Vaccine. 2012 Dec 17;31(1):234-41. doi: 10.1016/j.vaccine.2012.09.037. Epub 2012 Oct 11.
citation: Moscicki B et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
citation: Moscicki B et al. Anamnestic response to non-vaccine types elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.