Abstract
ABSTRACTThis community-randomized controlled trial was initiated to assess the overall and herd effects of 2 different human papillomavirus (HPV) immunization strategies in over 80,000 girls and boys aged 12–15 y in 33 communities in Finland (ClinicalTrials.gov NCT00534638). Overall, 14,838 adolescents received HPV-16/18 vaccine (2,440 boys and 12,398 girls) and 17,338 received hepatitis-B virus (HBV) vaccine (9,221 boys and 8,117 girls). In an interim analysis, vaccine safety was assessed by active monitoring and surveillance via health registry linkage. Active monitoring showed that the HPV-16/18 vaccine has acceptable safety and reactogenicity in boys. In all study participants, the observed incidences (per 100,000 person-years) of serious adverse events (SAEs) possibly related to vaccination were 54.3 (95% Confidence Interval [CI]: 34.0–82.1) in the HPV-16/18 group and 64.0 (95% CI: 43.2–91.3) in the HBV group. During the follow-up period for this interim analysis, the most common new-onset autoimmune diseases (NOADs; with incidence rate ≥15 per 100,000) in any group based on hospital discharge registry (HILMO) download were ulcerative colitis, juvenile arthritis, celiac disease, insulin-dependent diabetes mellitus (IDDM) and Crohn's disease. No increased NOAD incidences were observed in HPV-16/18 vaccine recipients compared to HBV vaccine recipients. In both the SAE possibly related- and HILMO-analyses, a lower incidence of IDDM was observed in HPV-16/18 vaccinees compared to HBV vaccinees (relative risks, 0.26 [95% CI: 0.03–1.24] and 0.16 [95% CI: 0.03–0.55], respectively).
Highlights
Virus-like particle (VLP)-based vaccines against oncogenic, highrisk human papillomavirus (HPV) types 16 and 18 have been licensed in most countries, most recently including a 9-valent HPV vaccine
The overall and specific, with regard to new-onset autoimmune diseases (NOADs), safety profile of the HPV-16/18 AS04-adjuvanted vaccine has been acceptable in all ages studied and in combination with other routine vaccines.[19,20,21,22,23,24]
We report interim safety results for the HPV-16/18 AS04adjuvanted vaccine administered to a large cohort of adolescents (ClinicalTrials.gov NCT00534638), with special emphasis on unique, quantitative population-based health care registry data on occurrence of NOADs post-vaccination
Summary
Virus-like particle (VLP)-based vaccines against oncogenic, highrisk human papillomavirus (HPV) types 16 and 18 have been licensed in most countries, most recently including a 9-valent HPV vaccine (Gardasil 9 [Merck & Co. Inc.]).[1,2,3,4,5,6] Basis for the licensure of CervarixÒ (GSK Vaccines) and Gardasil (Merck & Co., Inc.) was their acceptable safety profiles and vaccine efficacy (VE). The HPV-16/18 vaccine is formulated with the AS04 Adjuvant System, containing 3-O-desacyl-40-monophosphoryl lipid A (MPL; 50 mg) adsorbed on aluminum salt (500 mg Al3C), which has been shown to widely induce T-helper and memory B cell responses,[16] and probably is partially responsible for the wide cross-protectivity of the vaccine.[17,18] a theoretical adverse event of this enhanced immunogenicity might be the induction (or promotion) of (ongoing) autoimmune processes. The overall and specific, with regard to new-onset autoimmune diseases (NOADs), safety profile of the HPV-16/18 AS04-adjuvanted vaccine has been acceptable in all ages studied and in combination with other routine vaccines.[19,20,21,22,23,24] to date, safety data have been collected via conventional reporting of adverse events (AEs) and serious adverse events (SAEs) in clinical trials, and quantitative safety data from large cohorts of HPV-16/18 vaccinated adolescents and population-based health registers are sparse
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