Direct, indirect and total effectiveness of bivalent HPV vaccine in women in Galicia, Spain

Abstract

Bivalent human papillomavirus (HPV) vaccine was incorporated into the childhood vaccination calendar in Galicia, Spain in 2008. The objectives of this study were to estimate direct, indirect and total effectiveness of HPV vaccine and to identify sexual habits changes in the post-vaccination period in Galicia, Spain.Endocervical scrapings of 745 women attending 7 Health Areas of the Galician Public Health Service were collected in the post-vaccination period, from 2014–2017. Two groups were studied: women born between 1989 and 1993 (n = 397) and women born in 1994 or later (n = 348). Twelve high-risk human papillomavirus (HR-HPV) genotypes were detected by Cobas® 4800 HPV test (Roche Diagnostics, Mannheim, Germany). The Linear Array® HPV Genotyping Test (Roche Diagnostics) was used for HR-HPV genotype detection other than HPV 16/18. Information about sexual habits was collected by a self-filled questionnaire. Post-vaccination data were compared to previously published pre-vaccination data obtained between 2008 and 2010 in Galicia from women of the same age (18–26 years old, n = 523). The Stata 14.2 software was employed for statistical analyses.Data from 392 unvaccinated and 353 vaccinated women were compared. For unvaccinated and vaccinated women, HPV 16/18 prevalence was 9.2% and 0.8%, respectively, and HPV 31/33/45 prevalence was 8.4% and 1.1%, respectively. Direct, indirect and total effectiveness of the HPV vaccine were (%, 95% CI): 94 (72−99), 30 (-11−56) and 95 (79−99), respectively, for HPV 16/18 and 83 (46−94), -10 (-88−33) and 84 (54−94), respectively, for HPV 31/33/45. The number of women with first intercourse before 17 years old and 3 or more sexual partners along life was higher in the post-vaccination period (p < 0.05). A positive impact of bivalent HPV vaccine was observed, both on direct and cross protection. Sexual habits could have changed in the post-vaccination period.

Quadrivalent Human Papillomavirus Vaccine Effectiveness after 12 Years in Madrid (Spain)

“…The overall prevalence of HPV infection in our study is 10% higher than that described in other reports previously published in Spain [ 11 ]. In contrast to what has been published by Purriños et al, in a study carried out in a Spanish female population [ 12 ], we found no difference in overall HPV prevalence between VG and NVG.…”

“…When considering genotypes HPV16 and 31, 33 and 45 we also find an incidence reduction close to what was reported by the latter author. Purriños et al reported for this group of genotypes a significant decrease in the vaccinated group (8.4% vs. 1.1%), although the vaccine used in their study was Cervarix [ 12 ].…”

Priming effect of bivalent and quadrivalent vaccine for HPV 31/33/45/52: an exploratory analysis from two clinical trials

“…This observation is supported by prior study reports on the presence of detectable antibodies against these HPV types in a large proportion of subjects vaccinated with either 2vHPV or 4vHPV, 5,[18][19][20][21] and by existing robust data regarding partial cross-protection ensured by these vaccines. [6][7][8][9][10][11][12][13][14]22,23 As the time-intervals were different for receipt of 9vHPV in subjects previously vaccinated with 2vHPV (6 months apart) or 4vHPV (36-96 months apart), it was not possible to disentangle the effect of the type of vaccine and that of the interval before the 9vHPV on the persistence of priming. The similar priming activities is rather surprising considering that peak and plateau titers after the standard three doses against HPV16 and 18 are higher for 2vHPV than for 4vHPV, 24 and the longer interval between prime and boost for 4vHPV in our study.…”

“…4 Several clinical trials with two or three doses of 2vHPV and 4vHPV reported the presence of antibodies to several HPV types not included in these vaccines, 5 as well as significant cross-protection against infections and lesions related to HPV31/33 and 45. [6][7][8][9][10][11][12][13][14] However, this cross-protection seems to be limited when compared to direct protection induced by the 9vHPV. 3 We previously reported that a substantial proportion of subjects vaccinated with a single dose of 2vHPV (50-71%) or 4vHPV (58-87%) were seropositive to the five HPV VLP types included only in the 9vHPV.…”

Evidence of HPV vaccination efficacy comes from more than clinical trials

“…Cohort studies and surveillance statistics show dramatic falls in the proportions of young women infected with these HPV types in countries that have implemented HPV vaccination. [14][15][16][17][18][19][20][21][22] In England the prevalence of HPV16/18 in sexually active females aged 16-18years prior to vaccination was 15% this has dropped to 2% among those offered vaccination at age 12-13 years. Further in 2018, among 584 women tested at ages 16-18years there was no HPV detected (0%, 95%CI 0.0%-0.6%).…”