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Sustained Efficacy, Immunogenicity, and Safety Shown for GlaxoSmithKline’s HPV Vaccine
A long-term follow-up study (HPV-023; NCT00518336) shows the sustained efficacy, immunogenicity, and safety of GlaxoSmithKline's human papilloma virus (HPV) vaccine Cervarix. Women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine were followed for more than nine years, and vaccine efficacy (VE) against incident infection was 100%. This is the longest follow-up report for a licensed HPV vaccine. Visit https://www.landesbioscience.com/journals/vaccines/article/29532/ for the full paper. The article was published on June 19, 2014 in Human Vaccines & Immunotherapeutics. Persistent infection with HPV has been clearly established as the necessary cause of the overwhelming majority of cervical cancer cases. At least 40 different HPV types are known to infect the genital mucosa, of which approximately 15 are associated with cervical cancer. Among these types, HPV-16 and HPV-18 are the most common and responsible for approximately 70% of cervical cancers. Both HPV-16 and HPV-18 are included in the two licensed HPV vaccines (GSK's Cervarix and Merck's Gardasil), which are now widely available and used. Evidence of long-term efficacy against vaccine HPV-types is very important, particularly with respect to maintaining public confidence in mass vaccination programs. HPV vaccines initially were recommended for young girls and women 9-25 years of age who have not been exposed to HPV. Because HPV causes not only cervical cancer but also genital warts and anal cancer, HPV vaccines are also recommended for boys in many countries. An initial double-blind, randomized, multi-center vaccination study (HPV-001; NCT00689741) was started in 2001, followed for up to 27 months, and then followed by a long-term study of the entire cohort for up to 77 months (6,4 years) post initial vaccination (HPV-007; NCT00120848).