Enrolment of 22,000 adolescent women to cancer registry follow-up for long-term human papillomavirus vaccine efficacy: guarding against guessing.

Full Abstract

Human papillomaviruses (HPVs, most notably types 16 and 18) cause cervical carcinoma, the second most common cancer among women. Vaccination of adolescents against HPV16/18 might prevent large proportion of cervical and other anogenital cancers. However, because of ethical reasons this cannot be proven by clinical studies. To determine the long-term vaccine efficacy (VE) of HPV16/18 virus-like-particle (VLP) vaccine against cervical carcinoma in situ (CIS+) and invasive cervical carcinoma, the following three population-based cohorts of adolescent women have been enrolled:
(1) women vaccinated with the HPV vaccine; (2) women vaccinated with hepatitis A control vaccine; and (3) unvaccinated control women. These cohorts will be passively followed for cumulative incidence of CIS+ endpoints by population-based cancer registry. Overall 24,046 16- to 17-year-old adolescent women from 18 cities in Finland were invited between May 2004 and June 2005 to participate in a phase III trial with bivalent HPV16/18 VLP vaccine. A total of 58,996 18- to 19-year-old women were invited in May 2005 to participate as unvaccinated controls. Women who reported their willingness to participate in an HPV vaccination trial had they been 1-2 years younger were eligible. Cumulative incidence (CI) of CIS+ in our cohorts over 15 years is approximately 0.45%. VE of 70% against CIS+ with 80% power requires 3357-3189 HPV16/18 vaccine recipients, 3357-3189 other vaccine recipients, and 6714-9567 unvaccinated controls. We have now enrolled 2404 HPV16/18 vaccine recipients, 2404 hepatitis A-vaccine recipients, and 5130 unvaccinated controls. This enrolment in addition to our earlier enrolment in another phase III trial guarantees enough power so that by 2020 we can ultimately provide data on the efficacy of HPV16/18 vaccination against CIS+.

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Author information

Author/s: Lehtinen, Matti (M); Apter, Dan (D); Dubin, Gary (G); Kosunen, Elise (E); Isaksson, Rita (R); Korpivaara, Eeva-Leena (EL); Kyhä-Osterlund, Laura (L); Lunnas, Terhi (T); Luostarinen, Tapio (T); Niemi, Lubov (L); Palmroth, Johanna (J); Petäjä, Tiina (T); Rekonen, Sirpa (S); Salmivesi, Susanna (S); Siitari-Mattila, Mari (M); Svartsjö, Sofia (S); Tuomivaara, Leena (L); Vilkki, Marjo (M); Pukkala, Eero (E); Paavonen, Jorma (J);

Affiliation: University of Tampere, Tampere, Finland.

Journal and publication information

Publication Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: International journal of STD & AIDS (Int J STD AIDS), published in England. (Language: eng)

Reference: 2006-Aug; vol 17 (issue 8) : pp 517-21

Dates: Created 2006/08/23; Completed 2006/10/17; Revised 2006/11/15;

PMID: 16925896, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adolescent
Adult
Cervical Intraepithelial Neoplasia - immunology; prevention & control; virology
Cohort Studies
Female
Follow-Up Studies
Hepatitis A Vaccines - therapeutic use
Human papillomavirus 16 - immunology

Human papillomavirus 18 - immunology
Humans
Immunity, Herd
Papillomavirus Infections - immunology; prevention & control
Papillomavirus Vaccines
Registries
Uterine Cervical Neoplasms - immunology; prevention & control; virology
Viral Vaccines - therapeutic use

Associated Chemicals: Hepatitis A Vaccines (0) ; Papillomavirus Vaccines (0) ; Viral Vaccines (0)

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