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Original Investigation |

Association of Varying Number of Doses of Quadrivalent Human Papillomavirus Vaccine With Incidence of Condyloma

Eva Herweijer, MSc1; Amy Leval, PhD2,3; Alexander Ploner, PhD1; Sandra Eloranta, PhD1; Julia Fridman Simard, ScD4; Joakim Dillner, MD1; Eva Netterlid, PhD5,6,7; Pär Sparén, PhD1; Lisen Arnheim-Dahlström, PhD1
[+] Author Affiliations
1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden
2Department of Communicable Disease Control and Prevention for Stockholm County, Stockholm, Sweden
3Department of Medicine, Infectious Disease Unit, Karolinska Institutet, Stockholm, Sweden
4Department of Medicine, Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden
5Swedish Institute for Communicable Disease Control, Stockholm, Sweden
6Faculty of Medicine, Department of Clinical Sciences in Malmö, Lund University, Malmö, Sweden
7Department of Occupational and Environmental Dermatology, Skåne University Hospital, Malmö, Sweden
JAMA. 2014;311(6):597-603. doi:10.1001/jama.2014.95.
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Importance  Determining vaccine dose-level protection is essential to minimize program costs and increase mass vaccination program feasibility. Currently, a 3-dose vaccination schedule is recommended for both the quadrivalent and bivalent human papillomavirus (HPV) vaccines. Although the primary goal of HPV vaccination programs is to prevent cervical cancer, condyloma related to HPV types 6 and 11 is also prevented with the quadrivalent vaccine and represents the earliest measurable preventable disease outcome for the HPV vaccine.

Objective  To examine the association between quadrivalent HPV vaccination and first occurrence of condyloma in relation to vaccine dose in a population-based setting.

Design, Setting, and Participants  An open cohort of all females aged 10 to 24 years living in Sweden (n = 1 045 165) was followed up between 2006 and 2010 for HPV vaccination and first occurrence of condyloma using the Swedish nationwide population-based health data registers.

Main Outcomes and Measures  Incidence rate ratios (IRRs) and incidence rate differences (IRDs) of condyloma were estimated using Poisson regression with vaccine dose as a time-dependent exposure, adjusting for attained age and parental education, and stratified on age at first vaccination. To account for prevalent infections, models included a buffer period of delayed case counting.

Results  A total of 20 383 incident cases of condyloma were identified during follow-up, including 322 cases after receipt of at least 1 dose of the vaccine. For individuals aged 10 to 16 years at first vaccination, receipt of 3 doses was associated with an IRR of 0.18 (95% CI, 0.15-0.22) for condyloma, whereas receipt of 2 doses was associated with an IRR of 0.29 (95% CI, 0.21-0.40). One dose was associated with an IRR of 0.31 (95% CI, 0.20-0.49), which corresponds to an IRD of 384 cases (95% CI, 305-464) per 100 000 person-years, compared with no vaccination. The corresponding IRDs for 2 doses were 400 cases (95% CI, 346-454) and for 3 doses, 459 cases (95% CI, 437-482). The number of prevented cases between 3 and 2 doses was 59 (95% CI, 2-117) per 100 000 person-years.

Conclusions and Relevance  Although maximum reduction in condyloma risk was seen after receipt of 3 doses of quadrivalent HPV vaccine, receipt of 2 vaccine doses was also associated with a considerable reduction in condyloma risk. The implications of these findings for the relationship between number of vaccine doses and cervical cancer risk require further investigation.

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Figure 1.
Details on Study Exclusions and Population Analyzed to Study the Association Between Quadrivalent Human Papillomavirus Vaccination and Condyloma per Dose Level
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Figure 2.
Cumulative Incidence Proportion of Condyloma in Vaccinated and Unvaccinated Individuals

Total time used to calculate curves was 1 year (365 days). Cumulative incidence proportion of condyloma in those vaccinated is shown as a function of time since vaccination with 1 dose in days. Cumulative incidence proportion of condyloma in those unvaccinated was calculated based on the age structure of those vaccinated. Shaded areas indicate 95% confidence intervals.

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