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Infections, PapillomavirusPhase 2NCT00546078

Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America

A Phase 2 study testing Cervarix™ in people with Infections, Papillomavirus, run by GlaxoSmithKline at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 15 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
Cervarix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
17 sitesin 2 countries
Study dates
14 Jan 2008to 1 Dec 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States13 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Augusta, Georgia, 30912-3500

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Grove City, Pennsylvania, 16127

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15241

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Francisco, California, 94118

  • GSK Investigational Site

    Seattle, Washington, 98105

Other trials in United States

Canada4 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2C8

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0J9

Other trials in Canada

About this study

Official title: Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.

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.

Being tested
Cervarix™
Keywords
HPV vaccine, Cervical cancer, Human papillomavirus infection
Medical subject headings
Papillomavirus Infections, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervarix™Biological

    Also called GSK Biologicals' HPV Vaccine GSK580299

    Intramuscular injection, one or three doses

Study groups in NCT00546078
Study groupRoleWhat they receive
Cervarix™ 4-Dose GroupExperimentalSubjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Receives: Biological: Cervarix™
Cervarix™ 3-Dose GroupExperimentalSubjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Receives: Biological: Cervarix™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: At Day 7 and Month 1 (Day 30)

  2. Anti-HPV-16 and Anti-HPV-18 Antibody Titers

    Titers are given as geometric mean titers (GMTs) calculated on all subjects.

    Measured: At Day 7 and at Month 1 (Day 30)

Secondary outcomes (15)

  1. Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values

    Cut-off values assessed include 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

    Measured: At Month 7 and Month 18

  2. Anti-HPV-16 and Anti-HPV-18 Antibody Titers

    Titers are given as GMTs calculated on all subjects.

    Measured: At Month 7 and Month 18

  3. Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL

    Measured: Day 0, Month 1 (Day 30), Month 7 and Month 18

  4. Anti-HPV-31 and Anti-HPV-45 Antibody Titers

    Titers are given as geometric mean titers (GMTs) calculated on all subjects.

    Measured: Day 7, Month 1 (Day 30), Month 7 and Month 18

  5. Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types

    CD4 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

    An immune response is defined as 500 or more antigen-specific CD4 T-cells per million CD4 T-cells.

    Measured: Day 0, Month 1 [Day 30], Month 7 and Month 18

  6. Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types

    CD8 T cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma.

    An immune response is defined as 200 or more antigen-specific CD8 T-cells per million CD8 T-cells.

    Measured: Day 0, Month 1 [Day 30], Month 7 and Month 18

  7. Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types

    B-cell-mediated immune responses against the antigens HPV-16, HPV-18, HPV-31 and HPV-45 were measured by Enzyme-linked immunosorbent spot (ELISPOT) assay.

    A memory B-cell immune response was defined as presence of any antigen-specific memory B-cells per million B-cells.

    Measured: Day 0, Month 1 [Day 30], Month 7 and Month 18

  8. Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples

    Seropositivity was defined as the detection of antibody titers above the limit of quantification by Enzyme-Linked Immunosorbant Assay. Defining a cut-off is technically not possible for this assay.

    Analyses were done in all collected samples from the evaluable subjects who provided cervical samples, with < 200 erythrocytes per microliter.

    Measured: Day 0, Month 1 (Day 30), Month 7 and Month 18

  9. 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

    Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

    Analyses were done in all collected samples from the evaluable subjects who provided cervical samples with < 200 erythrocytes per microliter.

    Measured: Day 0, Month 1 (Day 30), Month 7 and Month 18

  10. Number of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed include pain, redness and swelling at the injection site.

    Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

    Measured: Within 7 days after vaccination

  11. Number of Subjects Reporting Solicited General Symptoms

    Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal discomfort, headache, myalgia, rash and urticaria.

    Solicited symptoms reported after the 4th vaccine dose in the 4-dose Group and across the 3 doses administered during this study in the 3-dose Group are disclosed.

    Measured: Within 7 days of vaccination

  12. Number of Subjects Reporting Unsolicited Adverse Events (AE)

    An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

    AEs reported after the 4th vaccine dose in the 4-dose Group and after the 3 doses administered in this study in the 3-dose Group are disclosed.

    Measured: Within 30 days of vaccination

  13. Outcome of Any Reported Pregnancies

    Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.

    Measured: From Day 0 up to Month 18

  14. Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)

    NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

    Measured: From Day 0 up to Month 18

  15. Number of Subjects Reporting Serious Adverse Events (SAEs)

    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    Measured: From Day 0 up to Month 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2007 (estimated)
  2. Study start14 Jan 2008
  3. Primary completion22 Dec 2008
  4. Study completion1 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00546078
Sponsor's protocol ID
109628
Status last verified
Oct 2016
First submitted
17 Oct 2007
Last updated
26 Jun 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • 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.

    PubMed 23063422

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cervarix™ in people with Infections, Papillomavirus, run by GlaxoSmithKline at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: At Day 7 and Month 1 (Day 30)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546078, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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