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

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

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.

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.

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

Inclusion Criteria: Participated in study 580299/001 and received all three doses of vaccine/placebo. Written informed consent obtained from the subject prior to enrollment Exclusion Criteria: Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

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.

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.

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. Erratum In: BMJ Open. 2016 Sep 02;6(9):e011371corr1.

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.

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