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Journal club 6. Facilitator: Pawin Puapornpong. A 9-Valent HPV Vaccine against Infection and Intraepithelial Neoplasia in Women. Background. Medthod. Result. Discussion. Conclusion. Background. Background. Medthod. Result. Discussion. Conclusion. Background.
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Journal club 6 Facilitator: Pawin Puapornpong
A 9-Valent HPV Vaccine against Infection and Intraepithelial Neoplasia in Women
Background Medthod Result Discussion Conclusion Background
Background Medthod Result Discussion Conclusion Background • 9vHPV is qvHPV plus five additional oncogenic types. • 9vHPV is offered to increased prevention of cervical cancer from 70% to 90%
Background Medthod Result Discussion Conclusion Hypothesis • 9vHPV has more efficacy to prevent cervical cancer than qvHPV. • 9vHPV and qvHPV would be similarly efficacy in preventing HPV-6,11,16 and 18.
Background Medthod Result Discussion Conclusion Reserch question • P(Patient):16-26yr women • I(Intervention) :9vHPV • C(control and comparison) :qvHPV • O(Outcome): 1Incidence of disease 2 Immunogenicity 3 adverse event
Background Medthod Result Discussion Conclusion Method • Type of randomized,international,double-blind control trial Study • Conducted in multiple medical center ininternational
Background Medthod Result Discussion Conclusion Method, Population:Inclusion criteria • 16-26 yr women • received all three doses of vaccine within 1 year • seronegative on day 1 of the study • Negative results on PCR of HPV type being from day 1 through month 7
Background Medthod Result Discussion Conclusion Method, Population:exclusion criteria • Had vaccination before study • Had cervical disease before study • History of abnormal PAP test • Loss to follow up • More than 4 sexual partner
Background Medthod Result Discussion Conclusion Method 14215 7106 7109 9vHPV qvHPV day1,2 and 6 month
Background Medthod Result Discussion Conclusion Medthod:follow-up • Swabs of labial, vulvar, perineal, perianal, endocervical,and ectocervical tissue to PCR for HPV and Pap test • At day 1 and at months 7, 12, 18, 24, 30, 36, 42, 48,and 54.
Background Medthod Result Discussion Conclusion Medthod • recorded oral temperatures on each of the 5 days after vaccination • Recorded adverse events related to the injection site and systemic adverse events 15 days after vaccination.
Background Medthod Result Discussion Conclusion Statistical analysis • Analyse by percent risk reduction,95%CI
Background Medthod Result Discussion Conclusion Result
Background Medthod Result Discussion Conclusion Result:incidence of disease
Background Medthod Result Discussion Conclusion Result:immunogenicity no statistical significant
Background Medthod Result Discussion Conclusion Result:adverse event
Background Medthod Result Discussion Conclusion Result • Incidence of diseased:9vHPV can protect diseased related to five additional oncogenic type more than qvHPV • Immunogenicity: 9vHPV generated Ab to HPV-6,11, 16, and 18 was noninferior by qHPV vaccine • Adverse events:9vHPV more likely had injection site events than qvHPV
Background Medthod Result Discussion Conclusion Discussion:Strength • Same characteristic population • Follow-up out come by immunological and pathological test • Double blind study
Background Medthod Result Discussion Conclusion Discussion:Limitation • No placebo control group • Follow-up was limited in duration 54 month
Background Medthod Result Discussion Conclusion Conclusion • The 9vHPV vaccine prevented infection and disease related to HPV-31, 33, 45, 52,and 58 more than qvHPV • 9vHPV generated an antibody response to HPV-6,11, 16, and 18 was noninferior by qHPV vaccine