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Effectiveness of HPV vaccination in women reaching screening age in Italy

Carozzi, F. M.; Ocello, C.; Burroni, E.; Faust, H. LU ; Zappa, M.; Paci, E.; Iossa, A.; Bonanni, P.; Confortini, M. and Sani, C. (2016) In Journal of Clinical Virology 84. p.74-81
Abstract

Background and objectives A randomized trial was conducted in Tuscany, Italy, to evaluate the effectiveness of HPV vaccination for 25 year old (yo) women who attend at the first time cervical cancer screening. The trial also evaluated immune response after vaccination, reductions of cytological abnormalities and the impact of vaccination on screening activity. Study design During 2010–2011, all 25 yo women who were invited to the Florence cervical cancer screening programme were also asked to participate in the trial. Enrolled women were randomized into study and control groups. Those in the study group were offered HPV vaccination after the usual Pap test. The cytology distribution and prevalence for any high risk (hr) HPV type were... (More)

Background and objectives A randomized trial was conducted in Tuscany, Italy, to evaluate the effectiveness of HPV vaccination for 25 year old (yo) women who attend at the first time cervical cancer screening. The trial also evaluated immune response after vaccination, reductions of cytological abnormalities and the impact of vaccination on screening activity. Study design During 2010–2011, all 25 yo women who were invited to the Florence cervical cancer screening programme were also asked to participate in the trial. Enrolled women were randomized into study and control groups. Those in the study group were offered HPV vaccination after the usual Pap test. The cytology distribution and prevalence for any high risk (hr) HPV type were compared at the subsequent screening round in an intention-to-treat analysis. The impact of HPV vaccination was evaluated per protocol comparing vaccinated women with the control group. Results Our results showed a reduction in HPV prevalence at recall for any hr-HPV type but it was not statistically significant, being 17.1% vs 21.4%, p = 0.20 in the study and control groups, respectively. If we restricted the analysis to vaccinated women, strong reductions of the HPV 16,18,31,33,45 and HPV 31,33,45 infections were observed, being 5.3% vs 12.8%, p < 0.01 and 2.1% vs 6.5%, p = 0.02, respectively. Significant reductions for any hr-HPV infection and for HPV 16 infection were also observed in women HPV 16/18 negative at enrolment, being 12% vs 21.4%, p < 0.01 and 0.6% vs 6.7%, p-value < 0.01, respectively. In women hr-HPV negative at enrolment no infections due to HPV 16 or HPV 18 were observed and there was a big reduction for any hr-HPV infection (7.1% vs 21.4% p < 0.01). A strong antibody response was observed not only for HPV 16 & 18 but also for their related types. Conclusions Our findings suggest that HPV vaccination at the age 25 is beneficial if it is offered to hr-HPV negative women. Our data will assist in developing a cost effectiveness model for choosing the best strategy to integrate screening and vaccination for the coming years. Clinical trial registration number is NCT02296255.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
25-year-old women, Cervical cancer screening, Cytological abnormalities, HPV, HPV vaccination, Immune response
in
Journal of Clinical Virology
volume
84
pages
8 pages
publisher
Elsevier
external identifiers
  • scopus:84991247257
  • wos:000388456200015
ISSN
1386-6532
DOI
10.1016/j.jcv.2016.09.011
language
English
LU publication?
yes
id
d45a751e-200f-4da5-9638-6b990d5eb178
date added to LUP
2016-10-28 10:01:40
date last changed
2017-09-18 11:28:33
@article{d45a751e-200f-4da5-9638-6b990d5eb178,
  abstract     = {<p>Background and objectives A randomized trial was conducted in Tuscany, Italy, to evaluate the effectiveness of HPV vaccination for 25 year old (yo) women who attend at the first time cervical cancer screening. The trial also evaluated immune response after vaccination, reductions of cytological abnormalities and the impact of vaccination on screening activity. Study design During 2010–2011, all 25 yo women who were invited to the Florence cervical cancer screening programme were also asked to participate in the trial. Enrolled women were randomized into study and control groups. Those in the study group were offered HPV vaccination after the usual Pap test. The cytology distribution and prevalence for any high risk (hr) HPV type were compared at the subsequent screening round in an intention-to-treat analysis. The impact of HPV vaccination was evaluated per protocol comparing vaccinated women with the control group. Results Our results showed a reduction in HPV prevalence at recall for any hr-HPV type but it was not statistically significant, being 17.1% vs 21.4%, p = 0.20 in the study and control groups, respectively. If we restricted the analysis to vaccinated women, strong reductions of the HPV 16,18,31,33,45 and HPV 31,33,45 infections were observed, being 5.3% vs 12.8%, p &lt; 0.01 and 2.1% vs 6.5%, p = 0.02, respectively. Significant reductions for any hr-HPV infection and for HPV 16 infection were also observed in women HPV 16/18 negative at enrolment, being 12% vs 21.4%, p &lt; 0.01 and 0.6% vs 6.7%, p-value &lt; 0.01, respectively. In women hr-HPV negative at enrolment no infections due to HPV 16 or HPV 18 were observed and there was a big reduction for any hr-HPV infection (7.1% vs 21.4% p &lt; 0.01). A strong antibody response was observed not only for HPV 16 &amp; 18 but also for their related types. Conclusions Our findings suggest that HPV vaccination at the age 25 is beneficial if it is offered to hr-HPV negative women. Our data will assist in developing a cost effectiveness model for choosing the best strategy to integrate screening and vaccination for the coming years. Clinical trial registration number is NCT02296255.</p>},
  author       = {Carozzi, F. M. and Ocello, C. and Burroni, E. and Faust, H. and Zappa, M. and Paci, E. and Iossa, A. and Bonanni, P. and Confortini, M. and Sani, C.},
  issn         = {1386-6532},
  keyword      = {25-year-old women,Cervical cancer screening,Cytological abnormalities,HPV,HPV vaccination,Immune response},
  language     = {eng},
  month        = {11},
  pages        = {74--81},
  publisher    = {Elsevier},
  series       = {Journal of Clinical Virology},
  title        = {Effectiveness of HPV vaccination in women reaching screening age in Italy},
  url          = {http://dx.doi.org/10.1016/j.jcv.2016.09.011},
  volume       = {84},
  year         = {2016},
}