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Ten-year follow-up ...
Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point-registry-based follow-up of three cohorts from randomized trials
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- Lehtinen, M (author)
- Karolinska Institutet
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- Lagheden, C (author)
- Karolinska Institutet
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Luostarinen, T (author)
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Eriksson, T (author)
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Apter, D (author)
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Harjula, K (author)
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Kuortti, M (author)
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Natunen, K (author)
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Palmroth, J (author)
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Petaja, T (author)
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Pukkala, E (author)
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Siitari-Mattila, M (author)
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Struyf, F (author)
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Nieminen, P (author)
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Paavonen, J (author)
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Dubin, G (author)
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- Dillner, J (author)
- Karolinska Institutet
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(creator_code:org_t)
- 2017-08-18
- 2017
- English.
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In: BMJ open. - : BMJ. - 2044-6055. ; 7:8, s. e015867-
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Abstract
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- Due to long lag time between infection/cancer diagnoses human papillomavirus (HPV) vaccination programs will deliver vaccine efficacy (VE) estimates against cancer end-points late. Cancer registry follow-up of population-based, randomised trial cohorts of vaccinated and unvaccinated women was undertaken for the estimation of VE against cervical intraepithelial neoplasia grade three and invasive cancer (CIN3+).MethodsWe report interim results with 98 561 person years of Finnish Cancer Registry -based follow-up of individually and/or cluster randomised cohorts of HPV-16/18 vaccinated and unvaccinated adolescent women enrolled in June 2003/2005, and between May 2004 and April 2005, respectively. The cohorts comprised 15 627 18- to 19-year-old unvaccinated women (NCT01393470), and 2 401 and 64 16- to 17-year-old HPV-16/18 vaccinated women participating the PATRICIA (NCT00122681) and HPV-012 (NCT00169494) trials, respectively. The age-aligned passive follow-up started 6 months after the clinical trials’ end.ResultsDuring the follow-up of 4.5 to 10 years post enrolment we identified 75 cases of cervical intraepithelial neoplasia grade 3 (CIN3) and 4 cases of invasive cervical cancer (ICC) in the unvaccinated cohort, and 4 CIN3 cases in the HPV-16/18 vaccinated women. Diagnostic blocks were available for HPV typing from 87% of the cases. CIN3+ lesions were detectable in 54 cases. HPV16 was found in 26 of 50 unvaccinated CIN3+ cases, and in 3 CIN3+ cases in the HPV-16/18 vaccinated women. The latter were all baseline positive for cervical HPV16 DNA. Baseline data was not available for the unvaccinated women. Intention-to-treat VE against any CIN3+ was 66% (95% CI 8, 88).ConclusionsTen years post vaccination the AS04-adjuvanted HPV-16/18 vaccine shows continued efficacy against CIN3+ irrespectively of HPV type. Vaccine efficacy was not observed in baseline HPV16 DNA positive subjects.Trial registration numberNCT01393470.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Folkhälsovetenskap, global hälsa, socialmedicin och epidemiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Public Health, Global Health, Social Medicine and Epidemiology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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BMJ open
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- By the author/editor
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Lehtinen, M
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Lagheden, C
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Luostarinen, T
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Eriksson, T
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Apter, D
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Harjula, K
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show more...
-
Kuortti, M
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Natunen, K
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Palmroth, J
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Petaja, T
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Pukkala, E
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Siitari-Mattila, ...
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Struyf, F
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Nieminen, P
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Paavonen, J
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Dubin, G
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Dillner, J
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show less...
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BMJ open
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Karolinska Institutet