Browsing by Author "Maansson, Roger"

Now showing 1 - 2 of 2
  • Thumbnail Image
    Item
    Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines
    (AAP, 2015-07) Schilling, Andrea; Parra, Mercedes Macias; Gutierrez, Maricruz; Restrepo, Jaime; Ucros, Santiago; Herrera, Teobaldo; Engel, Eli; Huicho, Luis; Shew, Marcia; Maansson, Roger; Caldwell, Nicole; Luxembourg, Alain; ter Meulen, Ajoke Sobanjo; Department of Pediatrics, IU School of Medicine
    BACKGROUND: This study in 11- to 15-year-old boys and girls compared the immunogenicity and safety of GARDASIL 9 (9-valent human papillomavirus [9vHPV] vaccine) administered either concomitantly or nonconcomitantly with 2 vaccines routinely administered in this age group (Menactra [MCV4; Neisseria meningitidis serotypes A/C/Y/W-135] or Adacel [Tdap; diphtheria/tetanus/acellular pertussis]). METHODS: Participants received 9vHPV vaccine at day 1 and months 2 and 6; the concomitant group (n = 621) received MCV4/Tdap concomitantly with 9vHPV vaccine at day 1; the nonconcomitant group (n = 620) received MCV4/Tdap at month 1. Antibodies to HPV-, MCV4-, and Tdap-relevant antigens were determined. Injection-site and systemic adverse events (AEs) were monitored for 15 days after any vaccination; serious AEs were monitored throughout the study. RESULTS: The geometric mean titers for all HPV types in 9vHPV vaccine 4 weeks after dose 3, proportion of subjects with a fourfold rise or greater in titers for 4 N meningitidis serotypes 4 weeks after injection with MCV4, proportion of subjects with antibody titers to diphtheria and tetanus ≥0.1 IU/mL, and geometric mean titers for pertussis antigens 4 weeks after injection with Tdap were all noninferior in the concomitant group compared with the nonconcomitant group. Injection-site swelling occurred more frequently in the concomitant group. There were no vaccine-related serious AEs. CONCLUSIONS: Concomitant administration of 9vHPV vaccine with MCV4/Tdap was generally well tolerated and did not interfere with the antibody response to any of these vaccines. This strategy would minimize the number of visits required to deliver each vaccine individually.
  • Thumbnail Image
    Item
    Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial
    (BMJ Publishing Group, 2010-07-20) The FUTURE I/II Study Group; Dillner, Joakim; Kjaer, Susanne K.; Wheeler, Cosette M.; Sigurdsson, Kristján; Iversen, Ole-Erik; Hernandez-Avila, Mauricio; Perez, Gonzalo; Brown, Darron R.; Koutsky, Laura A.; Tay, Eng Hseon; García, Patricia; Ault, Kevin A.; Garland, Suzanne M.; Leodolter, Sepp; Olsson, Sven-Eric; Tang, Grace W.K.; Ferris, Daron G.; Paavonen, Jorma; Lehtinen, Matti; Steben, Marc; Bosch, Xavier; Joura, Elmar A.; Majewski, Slawomir; Muñoz, Nubia; Myers, Evan R.; Villa, Luisa L; Taddeo, Frank J.; Roberts, Christine; Tadesse, Amha; Bryan, Janine T.; Maansson, Roger; Lu, Shuang; Vuocolo, Scott; Hesley, Teresa M.; Barr, Eliav; Haupt, Richard; Medicine, School of Medicine
    Objectives To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months’ follow-up. Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy. Intervention Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6. Main outcome measures Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied. Results In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma. Conclusions Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up.