E fficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL)
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Transcript of E fficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL)
Efficacy of quadrivalent human papillomavirus
(types 6, 11, 16 and 18 ) vaccine) (GARDASIL
inJapanese women aged 18–26 years
Hiroyuki Yoshikawa,1 Keiko Ebihara,2 Yoshiyuki Tanaka2,4 and Kiichiro Noda3
Total admission
160
surgical 77(48.1%)
medical 83(51.9%)
1030509 512
Participants underwentgynecologicalexaminations
cervicovaginal sampling for HPV DNA
serum neutralizing antibodies to HPV
Papanicolau testing
Human papillomavirus (HPV)-related genital warts are
considered to be the most common sexually transmitted
Disease.HPV 6 and HPV 11 are found in over 90% of
anogenital warts cases
Treatments for genital wartsointments
(5-FU, bleomycin, imiquimod,)
surgical treatments(laser ablation)
electronic iron and liquid nitrogen
In addition to leading to genital warts, infection with HPV is
known to lead to cervical cancer. HPV has been detected in 99.7% of patients with cervical cancer and HPV infection is considered to be a necessary prerequisite of
the disease
A meta-analysis demonstrated that HPV16 and 18 were the most common types and together were associated with 58.8% of cervical
cancer in Japan. Based on a recent report, approximately 67.1% of cervical cancers in Japan are considered to be
related to HPV types 16 and 18
HPV infection is seen as a very important
risk factor for vulvar, vaginal and anal
cancers.
Characteristics by vaccination group
not pregnant
no previous abnormal Pap smears
reported a lifetime history of four or fewer malesex partners
Participants and Methods
Participants were required to use
effective contraception during the vaccination
phase.
A 0.5 mL vaccine or placebo was given by IM injection at
day 1, month 2 and
month 6 .
Temperatures were also recorded orally every day inthe evening for 4 days after
vaccination and the participant was to note
adverse events by standard diary card for 15 days
after vaccination.
Gynecological examination was done at day
1 and at months 7, 12, 18, 24 and 30.
A ThinPrep Pap test and external genital and cervical swabs for PCR analysis of HPV were obtained from
all participants at day 1 and at
months 7, 12, 18, 24 and 30.Biopsy samples of external genital lesions identified during the study
were taken and serum samples were obtained at day 1 and months 2, 3, 7,
18 and 30
Women underwent colposcopy if they were diagnosed with atypical
squamous cells,low-grade squamous intraepithelial
lesions, high-grade squamous intraepithelial
lesions or atypical
glandular cells.
Results
Combined incidence of persistent infection or
disease with HPV 6, 11, 16 or 18 fell
by 87.6%, with HPV 6 or 11 by 73.1%
and with HPV 16 or 18 by 94.5%
in those assigned vaccine compared with those
assigned placebo
In addition, the vaccine was well tolerated in Japanesewomen aged 18–26 years. Quadrivalent HPV vaccine
couldsignificantly reduce the
acquisition of infection and clinical
disease caused by HPV types 6, 11, 16 and 18.
Discussion
We have shown that qHPV vaccine is efficacious
against HPV types that cause cancer and genital
warts in Japan by observing a combined primary end-point of both persistent
infection and genital
disease.
Vaccine efficacy against this end-point was 87.6% in the
per-protocol efficacy population. Furthermore,
efficacy with regard to HPV types closely related to
cervical cancer (types 16 and 18) was 94.5% in the per-protocol population
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