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Presentation transcript:

Facilitator: Pawin Puapornpong Journal club 6 Facilitator: Pawin Puapornpong

A 9-Valent HPV Vaccine against Infection and Intraepithelial Neoplasia in Women

Background Medthod Result Discussion Conclusion Background human papillomavirus (HPV) causes premalignant and malignant lesions of the cervix,vagina, vulva,anus,penis,oropharynx,as well as genital warts HPV vaccine was efficacious against condyloma and cervical, vaginal, vulvar, and anal dysplasia Current qHPV vaccine can protect cervical cancer 70% five

Background 9vHPV is qvHPV plus five additional oncogenic types. 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. Hypothesis have 2 point they are

Reserch question P(Patient):16-26yr women I(Intervention) :9vHPV 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 in international

Method, Population:Inclusion criteria 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

Method, Population:exclusion criteria 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

day1,2 and 6 month Method 14215 7106 7109 9vHPV qvHPV Background Medthod Result Discussion Conclusion Method 14215 7106 7109 9vHPV qvHPV Vaccines were administered as a 0.5-ml intramuscular injection in three doses, on day 1 and at month 2 and month 6. 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. Participants with an abnormal result on a Pap test were referred for colposcopy ang algorhythm mx

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. Vaccination report card

Statistical analysis Analyse by percent risk reduction,95%CI Background Medthod Result Discussion Conclusion Statistical analysis Analyse by percent risk reduction,95%CI

Background Medthod Result Discussion Conclusion Result

Result:incidence of disease Background Medthod Result Discussion Conclusion Result:incidence of disease

Result:immunogenicity 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 most common events (incidence ≥2%) being pain, swelling, erythema, and pruritus

Discussion:Strength Same characteristic population Background Medthod Result Discussion Conclusion Discussion:Strength Same characteristic population Follow-up out come by immunological and pathological test Double blind study

Discussion:Limitation Background Medthod Result Discussion Conclusion Discussion:Limitation No placebo control group Follow-up was limited in duration 54 month So cannot campare with unvaccinated poppulation

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