Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up.
Prophylactic human papillomavirus (HPV) vaccines are now available and vaccination programs are being widely implemented, targeting adolescent girls prior to sexual debut. Since the risk of HPV exposure persists throughout a woman's sexual life, the duration of protection provided by vaccination is critical to the overall vaccine effectiveness. We report the long-term efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine (Cervarix (®) ) up to 8.4 y after the first vaccine dose.       In an initial placebo-controlled study performed in US, Canada and Brazil, women aged 15-25 y with normal cervical cytology, HPV-16/18 seronegative by ELISA, DNA-negative for 14 oncogenic HPV types by PCR, received either the HPV-16/18 vaccine or placebo (n = 1,113). Subjects were followed up to 6.4 y after the first dose (n = 776). We report an additional 2-y follow-up for women enrolled from the Brazilian centers from the initial study (n = 436).   During the current follow-up study (HPV-023, NCT00518336), no new infection or lesions associated with HPV-16/18 occurred in the vaccine group. Vaccine efficacy over the entire follow-up (up to 8.4 y) was 95.1% (84.6, 99.0) for incident infection, 100% (79.8, 100) for 6-mo persistent infection, 100% (56.1, 100) for 12-mo persistent infection and 100% (< 0, 100) for CIN2+ associated with HPV-16/18. All women in the vaccine group remained seropositive to both HPV-16/18, with antibody titers for total and neutralizing antibodies remaining several-folds above natural infection levels. The safety profile was clinically acceptable for both vaccine and control groups. This is, to date, the longest follow-up study for a licensed cervical cancer vaccine.
Hospital Leonor Mendes de Barros-Secretaria da Saúde de São Paulo, Sao Paulo, Brazil. ceciliaroteli@terra.com.br
Cecilia M
CM
Roteli-Martins
Paulo
P
Naud
Paola
P
De Borba
Julio C
JC
Teixeira
Newton S
NS
De Carvalho
Toufik
T
Zahaf
Nervo
N
Sanchez
Brecht
B
Geeraerts
Dominique
D
Descamps
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D001938:Brazil; D002170:Canada; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D030361:Papillomavirus Infections / Q000150:complications* / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D010919:Placebos / Q000008:administration & dosage; D011247:Pregnancy; D013997:Time Factors; D014481:United States; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control* / Q000821:virology*; D055815:Young Adult
D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D010919:Placebos; C510352:human papillomavirus vaccine, L1 type 16, 18