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Infections, PapillomavirusPhase 2NCT00120848

Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

A Phase 2 study testing HPV 16/18 VLP AS04 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 27 sites in 3 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

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). Read more about this study

Who is it for?
Ages 20 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
HPV 16/18 VLP AS04
How many people
776 participants
Where
27 sitesin 3 countries
Study dates
Nov 2003to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 20 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participated in study 580299/001 and received all three doses of vaccine/placebo.
  • Written informed consent obtained from the subject prior to enrollment

Who cannot join

  • Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

Trial locations and contacts

27 sites in 3 countries.

27 sites in 3 countries

United States17 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87131

  • GSK Investigational Site

    Augusta, Georgia, 30912-3500

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Houston, Texas, 77058

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Morristown, New Jersey, 07960

  • 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, 78205-2489

  • GSK Investigational Site

    San Francisco, California, 94110

  • GSK Investigational Site

    San Francisco, California, 94143-0503

  • GSK Investigational Site

    Seattle, Washington, 98105

  • GSK Investigational Site

    West Jordan, Utah, 84084

Other trials in United States

Brazil5 sites

  • GSK Investigational Site

    Campinas, 13083-970

  • GSK Investigational Site

    Curitiba, Paraná, 80060-900

  • GSK Investigational Site

    Fortaleza

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • GSK Investigational Site

    São Paulo, São Paulo, 01409 902

Other trials in Brazil

Canada5 sites

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2C8

  • GSK Investigational Site

    Langley, British Columbia, V3A 4H9

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1E 2C2

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0W3

Other trials in Canada

About this study

Official title: Study of the Efficacy of Candidate HPV 16/18 VLP Vaccine in the Prevention of HPV-16 and/or HPV-18 Cervical Infection in Adolescent & Young Adult Women in North America and Brazil Vaccinated in Primary Study 580299/001

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.

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

Being tested
HPV 16/18 VLP AS04
Keywords
HPV vaccine efficacy, Prophylaxis HPV 16/18 infections
Medical subject headings
Papillomavirus Infections

What participants receive

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

  • HPV 16/18 VLP AS04Biological

What is being measured

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

  1. Incident cervical infection with HPV-16 and/or HPV-18

Secondary outcomes (7)

  1. Persistent cervical infection (6-month definition) with HPV 16 and/or HPV 18.

  2. Persistent cervical infection (6-month definition) with oncogenic HPV types.

  3. Incident cervical infection with oncogenic HPV types.

  4. Histopathologically-confirmed CIN 1+ or CIN 2+ associated with HPV 16 and/or HPV 18 detected within the lesional component of the cervical tissue specimen.

  5. Histopathologically-confirmed CIN 1+ or CIN 2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen.

  6. Abnormal cytology associated with an HPV-16 and/or HPV-18 cervical infection.

  7. Abnormal cytology associated with oncogenic HPV type cervical infection.

Timeline

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

  1. First posted19 Jul 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionJul 2007
  4. Study completionJul 2007

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00120848
Sponsor's protocol ID
580299/007
Status last verified
Nov 2016
First submitted
12 Jul 2005
Last updated
4 Nov 2016
Results posted
No
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

  • David MP, Van Herck K, Hardt K, Tibaldi F, Dubin G, Descamps D, Van Damme P. Long-term persistence of anti-HPV-16 and -18 antibodies induced by vaccination with the AS04-adjuvanted cervical cancer vaccine: modeling of sustained antibody responses. Gynecol Oncol. 2009 Dec;115(3 Suppl):S1-6. doi: 10.1016/j.ygyno.2009.01.011. Epub 2009 Feb 12.

    PubMed 19217149

  • Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.

    PubMed 19221517

  • Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, Jenkins D, Schuind A, Costa Clemens SA, Dubin G; HPV Vaccine Study group. Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial. Lancet. 2006 Apr 15;367(9518):1247-55. doi: 10.1016/S0140-6736(06)68439-0.

    PubMed 16631880

  • Katherine A et al. (2012) Adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use. Adis Drug Eval Drug Prof. 28(3):1-6.

  • GlaxoSmithKline Vaccine HPV-007 Study Group; Romanowski B, de Borba PC, Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, Aoki F, Ramjattan B, Shier RM, Somani R, Barbier S, Blatter MM, Chambers C, Ferris D, Gall SA, Guerra FA, Harper DM, Hedrick JA, Henry DC, Korn AP, Kroll R, Moscicki AB, Rosenfeld WD, Sullivan BJ, Thoming CS, Tyring SK, Wheeler CM, Dubin G, Schuind A, Zahaf T, Greenacre M, Sgriobhadair A. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet. 2009 Dec 12;374(9706):1975-85. doi: 10.1016/S0140-6736(09)61567-1.

    PubMed 19962185

  • Schwarz TF et al. (2011) Overview of clinical evidence: Cervarix. Future Medicine - Human Papillomavirus Vaccines. 38-50.

  • Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

    PubMed 18845199

  • El-Zein M, Ramanakumar AV, Naud P, Roteli-Martins CM, de Carvalho NS, Colares de Borba P, Teixeira JC, Moscicki AB, Harper DM, Tyring SK, Ramjattan B, Dubin G, Franco EL; HPV-007 Study Group. Determinants of Acquisition and Clearance of Human Papillomavirus Infection in Previously Unexposed Young Women. Sex Transm Dis. 2019 Oct;46(10):663-669. doi: 10.1097/OLQ.0000000000001053.

    PubMed 31464859

  • Ramanakumar AV, Naud P, Roteli-Martins CM, de Carvalho NS, de Borba PC, Teixeira JC, Blatter M, Moscicki AB, Harper DM, Romanowski B, Tyring SK, Ramjattan B, Schuind A, Dubin G, Franco EL; HPV-007 Study Group. Incidence and duration of type-specific human papillomavirus infection in high-risk HPV-naive women: results from the control arm of a phase II HPV-16/18 vaccine trial. BMJ Open. 2016 Aug 26;6(8):e011371. doi: 10.1136/bmjopen-2016-011371.

    PubMed 27566633

  • Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, Zahaf T, Catteau G, Geeraerts B, Descamps D. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother. 2014;10(8):2147-62. doi: 10.4161/hv.29532.

    PubMed 25424918

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HPV 16/18 VLP AS04 in people with Infections, Papillomavirus, run by GlaxoSmithKline at 27 sites in 3 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 2 inclusion and 1 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Brazil, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incident cervical infection with HPV-16 and/or HPV-18. 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 NCT00120848, which also lists 10 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 4 Nov 2016.

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