Browsing by Author "Van Damme, Pierre"
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Publication Immunogenicity of the 9-valent human papillomavirus vaccine: Post hoc analysis from five phase 3 studies(2025) Giuliano, Anna; Palefsky, Joel; Goldstone, Stephen; Bornsteind, Jacob; De Coster, Ilse; Guevara, Ana; Mogensen, Ole; Schilling Redlich, Andrea; Van Damme, Pierre; Vandermeulen, Corinne; Ellison, Misoo; Thomas Group; Kaplan, Susan; Lin, Jianxin; Bonawitz, Rachael; Luxembourg, AlainPost hoc analyses of 9-valent human papillomavirus (9vHPV) vaccine immunogenicity were conducted in five Phase 3 studies that enrolled males. Month 7 antibody geometric mean titers (GMTs) after three 9vHPV vaccine doses were analyzed in 10,024 males/females aged 16-26 years from studies 001 (NCT00543543), 002 (NCT00943722), 003 (NCT01651949), and 020 (NCT02114385). Covariates considered were age, gender, sexual orientation, region of residence, and race. GMTs among 2599 males/females aged 9-15 years (studies 002 and 010 [NCT01984697]) were assessed 6 months after one, two, and three 9vHPV vaccine doses. 9vHPV vaccine immunogenicity was robust across populations. Month 7 GMTs were generally higher in participants aged 16-21 versus 22-26 years. Region and race minimally impacted immunogenicity. Adjusted integrated analysis showed lower immunogenicity in men who have sex with men (MSM) versus heterosexual men (HM) for nine HPV types, and higher immunogenicity in HM versus females for seven HPV types. Among 9-15-year-olds, trends toward higher GMTs in males versus females post-Dose 3, similar GMTs post-Dose 2, and lower post-Dose 1 were observed. In conclusion, 9vHPV vaccine immunogenicity was robust in males aged 16-26 years across a range of baseline characteristics. GMT ratios for males versus females aged 9-15 years tended to increase with more doses.Item Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials(American Academy of Pediatrics, 2016) Edson, Moreira; Block, Stan; Ferris, Daron; Giuliano, Anna; Iversen, Ole-Erik; Joura, Elmar; Kosalaraksa, Pope; Schilling, Andrea; Van Damme, Pierre; Bornstein, Jacob; Bosch, Xavier; Pils, Sophie; Cuzick, Jack; Garland, Suzanne; Huh, Warner; Kjaer, Susanne; Qi, Hong; Hyatt, Donna; Martin, Jason; Moeller, Erin; Ritter, Michael; Baudin, Martine; Luxembourg, AlainOBJECTIVES: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age. METHODS: Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome. RESULTS: The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population. CONCLUSIONS: The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination.