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

Conditions

Infections, Papillomavirus

Keywords

HPV vaccine efficacy, Prophylaxis HPV 16/18 infections

Brief 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). 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.

Mariam El‐Zein, Agnihotram V. Ramanakumar, Paulo Naud, Cecília Roteli-Martins, Newton Sérgio de Carvalho et al. (13 authors)

Sexually Transmitted Diseases2019-08-2915 citations

10.1097/olq.0000000000001053

Ten-year immune persistence and safety of the HPV-16/18 AS04-adjuvanted vaccine in females vaccinated at 15-55 years of age.

Schwarz TF, Galaj A, Spaczynski M, Wysocki J, Kaufmann AM, Poncelet S, Suryakiran PV, Folschweiller N, Thomas F, Lin L, Struyf F.

2017-10-0552 citations

10.1002/cam4.1155

Incidence and duration of type-specific human papillomavirus infection in high-risk HPV-naïve women: results from the control arm of a phase II HPV-16/18 vaccine trial

Agnihotram V. Ramanakumar, Paulo Naud, Cecília Roteli-Martins, Newton Sérgio de Carvalho, Paola Colares de Borba et al. (15 authors)

BMJ Open2016-08-0142 citations

10.1136/bmjopen-2016-011371

Randomized Open Trial Comparing 2-Dose Regimens of the Human Papillomavirus 16/18 AS04-Adjuvanted Vaccine in Girls Aged 9–14 Years Versus a 3-Dose Regimen in Women Aged 15–25 Years

Thanyawee Puthanakit, Li‐Min Huang, Cheng‐Hsun Chiu, Ren-Bin Tang, Tino F. Schwarz et al. (22 authors)

The Journal of Infectious Diseases2016-02-0346 citations

10.1093/infdis/jiw036

Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study

Barbara Romanowski, Tino F. Schwarz, Linda Ferguson, Klaus Peters, Marc Dionne et al. (11 authors)

Human Vaccines & Immunotherapeutics2015-07-1593 citations

10.1080/21645515.2015.1065363

Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial.

Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D.

2014-12-0117 citations

10.1097/inf.0000000000000460

Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study.

Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Gałaj A, Schulze K, Suryakiran P, Thomas F, Descamps D.

2014-09-1133 citations

10.1111/1471-0528.13070

Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine

Paulo Naud, Cecília Roteli-Martins, Newton Sérgio de Carvalho, Júlio César Teixeira, Paola Colares de Borba et al. (10 authors)

Human Vaccines & Immunotherapeutics2014-06-19246 citations

10.4161/hv.29532

Efficacy of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical intraepithelial neoplasia and cervical infection in young Japanese women

Ryo Konno, Hiroyuki Yoshikawa, Marie Okutani, Wim Quint, P.V. Suryakiran et al. (7 authors)

Human Vaccines & Immunotherapeutics2014-04-2438 citations

10.4161/hv.28712

Results disclosure of papilloma vaccine studies in humans completed before January 1st, 2011.

Ramirez Jorge H

Figshare2014-01-01

10.6084/m9.figshare.1158703.v3

Results disclosure of papilloma vaccine studies in humans co.

Jorge Herrera Ramírez

Figshare2014-01-01

10.6084/m9.figshare.1158652.v1

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.

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.

2009-12-01258 citations

10.1016/s0140-6736(09)61567-1

Interventions

BIOLOGICALHPV 16/18 VLP AS04

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 30 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Incident cervical infection with HPV-16 and/or HPV-18	—

Secondary

Measure	Time frame
Persistent cervical infection (6-month definition) with oncogenic HPV types.	—
Incident cervical infection with oncogenic HPV types.	—
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.	—
Persistent cervical infection (6-month definition) with HPV 16 and/or HPV 18.	—
Abnormal cytology associated with an HPV-16 and/or HPV-18 cervical infection.	—
Abnormal cytology associated with oncogenic HPV type cervical infection.	—
Histopathologically-confirmed CIN 1+ or CIN 2+ associated with oncogenic HPV types detected within the lesional component of the cervical tissue specimen.	—

Countries

Brazil, Canada, United States

Outcome results

None listed