Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years
This manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine....
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-06-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1692557 |
| _version_ | 1827809583578480640 |
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| author | Dan Bi Dan Apter Tiina Eriksson Mari Hokkanen Julia Zima Silvia Damaso Maaria Soila Gary Dubin Matti Lehtinen Frank Struyf |
| author_facet | Dan Bi Dan Apter Tiina Eriksson Mari Hokkanen Julia Zima Silvia Damaso Maaria Soila Gary Dubin Matti Lehtinen Frank Struyf |
| author_sort | Dan Bi |
| collection | DOAJ |
| description | This manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine. The total vaccination cohort included 32,175 adolescents aged 12–15 y at vaccination of whom 14,837 received the AS04-HPV-16/18 vaccine and 17,338 received the hepatitis-B virus vaccine (control). Spontaneous reporting of serious adverse events (SAEs) combined with surveillance using nation-wide health registries showed an acceptable safety profile of the AS04-HPV-16/18 vaccine. During the study period (up to 6.5 y), the incidences (per 100,000 person-years) of reported SAEs considered as possibly related to vaccination were 39.1 (95% confidence interval [CI]: 25.3–57.7) and 39.8 (95%CI: 26.8–56.8) in the HPV and control groups, respectively. The most frequently reported new-onset autoimmune diseases (NOADs) were ulcerative colitis (incidence rates of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn’s disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9). Of 1,344 pregnancies reported (777 and 567 in the HPV and control groups, respectively), most resulted in elective termination (58.4% and 58.6%), birth of a live infant (32.7% and 32.3%), or in spontaneous abortion (8.0% and 7.9%). No major, registered congenital anomalies were identified. The incidence rates of NOADs and pregnancy outcomes were generally balanced between groups. No specific safety signals were identified in the population-based health registry surveillance. |
| first_indexed | 2024-03-11T22:43:33Z |
| format | Article |
| id | doaj.art-3791954e68524bfea031649056a69d4e |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:33Z |
| publishDate | 2020-06-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-3791954e68524bfea031649056a69d4e2023-09-22T08:45:34ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-06-011661392140310.1080/21645515.2019.16925571692557Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 yearsDan Bi0Dan Apter1Tiina Eriksson2Mari Hokkanen3Julia Zima4Silvia Damaso5Maaria Soila6Gary Dubin7Matti Lehtinen8Frank Struyf9GSKFamily Federation of FinlandUniversity of TampereUniversity of TampereEMD SeronoGSKGSKTakeda PharmaceuticalsUniversity of TampereGSKThis manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine. The total vaccination cohort included 32,175 adolescents aged 12–15 y at vaccination of whom 14,837 received the AS04-HPV-16/18 vaccine and 17,338 received the hepatitis-B virus vaccine (control). Spontaneous reporting of serious adverse events (SAEs) combined with surveillance using nation-wide health registries showed an acceptable safety profile of the AS04-HPV-16/18 vaccine. During the study period (up to 6.5 y), the incidences (per 100,000 person-years) of reported SAEs considered as possibly related to vaccination were 39.1 (95% confidence interval [CI]: 25.3–57.7) and 39.8 (95%CI: 26.8–56.8) in the HPV and control groups, respectively. The most frequently reported new-onset autoimmune diseases (NOADs) were ulcerative colitis (incidence rates of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn’s disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9). Of 1,344 pregnancies reported (777 and 567 in the HPV and control groups, respectively), most resulted in elective termination (58.4% and 58.6%), birth of a live infant (32.7% and 32.3%), or in spontaneous abortion (8.0% and 7.9%). No major, registered congenital anomalies were identified. The incidence rates of NOADs and pregnancy outcomes were generally balanced between groups. No specific safety signals were identified in the population-based health registry surveillance.http://dx.doi.org/10.1080/21645515.2019.1692557human papillomavirus (hpv)as04-adjuvanted hpv-16/18 vaccineadolescentssafetyautoimmune diseaseinsulin-dependent diabetes mellitus |
| spellingShingle | Dan Bi Dan Apter Tiina Eriksson Mari Hokkanen Julia Zima Silvia Damaso Maaria Soila Gary Dubin Matti Lehtinen Frank Struyf Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years Human Vaccines & Immunotherapeutics human papillomavirus (hpv) as04-adjuvanted hpv-16/18 vaccine adolescents safety autoimmune disease insulin-dependent diabetes mellitus |
| title | Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years |
| title_full | Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years |
| title_fullStr | Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years |
| title_full_unstemmed | Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years |
| title_short | Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12–15 years: end-of-study results from a community-randomized study up to 6.5 years |
| title_sort | safety of the as04 adjuvanted human papillomavirus hpv 16 18 vaccine in adolescents aged 12 15 years end of study results from a community randomized study up to 6 5 years |
| topic | human papillomavirus (hpv) as04-adjuvanted hpv-16/18 vaccine adolescents safety autoimmune disease insulin-dependent diabetes mellitus |
| url | http://dx.doi.org/10.1080/21645515.2019.1692557 |
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