Gardasil quadrivalent HPV (Types 6,11,16,18) vaccineHPV ဗိုင်းရပ်စ်ပိုးကြောင့်ဖြစ်သော သားအိမ်ခေါင်းကင်ဆာ၊ စအို ကင်ဆာ၊ လည်ချောင်းကင်ဆာ၊လိင်တံကင်ဆာကာကွယ်ဆေး
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အမေရိကန် အစားအသောက်နှင့်ဆေးဝါးကြီးကြပ်ရေး (USFDA) မှ အသိအမှတ်ပြုထားသော HPV(Human papilloma virus) ဗိုင်းရပ်စ်ပိုးကြောင့်ဖြစ်သော သားအိမ်ခေါင်းကင်ဆာ၊ စအို ကင်ဆာ၊ လည်ချောင်းကင်ဆာ၊လိင်တံကင်ဆာတို့အား ကာကွယ်နိုင်သည့် ကာကွယ်ဆေး ဖြစ်ပြီး ကျားမ မရွေး အသက် ၉နှစ်မှ ၄၅ နှစ်အထိထိုးနိုင်ပြီး ကလေးဆို ၂ကြိမ် လူကြီးဆို လျှင် ၃ ကြိမ် အား ၀-၆-၁၂ လအချိန်ဇယားများအတိုင်းထိုးနိုင်ပါသည်။
HPV Vaccine Schedule and Dosing
About 85% of people will get an HPV infection in their lifetime. Recommending HPV vaccination for all 11–12 year-olds can protect them long before they are ever exposed. CDC recommends two doses of HPV vaccine for all adolescents at age 11 or 12 years.
Who Gets 2 Doses?
- A 2-dose schedule is recommended for people who get the first dose before their 15th birthday. In a 2-dose series, the second dose should be given 6–12 months after the first dose (0, 6–12 month schedule).
- The minimum interval is 5 months between the first and second dose. If the second dose is administered after a shorter interval, a third dose should be administered a minimum of 5 months after the first dose and a minimum of 12 weeks after the second dose.
- If the vaccination schedule is interrupted, vaccine doses do not need to be repeated (no maximum interval).
- Immunogenicity studies have shown that 2 doses of HPV vaccine given to 9–14 year-olds at least 6 months apart provided as good or better protection than 3 doses given to older adolescents or young adults.
Who Gets 3 Doses?
- A 3-dose schedule is recommended for people who get the first dose on or after their 15th birthday, and for people with certain immunocompromising conditions.
- In a 3-dose series, the second dose should be given 1–2 months after the first dose, and the third dose should be given 6 months after the first dose (0, 1–2, 6 month schedule).
- The minimum intervals are 4 weeks between the first and second dose, 12 weeks between the second and third doses, and 5 months between the first and third doses. If a vaccine dose is administered after a shorter interval, it should be re-administered after another minimum interval has elapsed since the most recent dose.
- If the vaccination schedule is interrupted, vaccine doses do not need to be repeated (no maximum interval).
Contents
Quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine.
Action
Pharmacotherapeutic Group: GARDASIL is a recombinant quadrivalent vaccine that protects against human papillomavirus (HPV).
Pharmacology: Pharmacodynamics: Mechanism of Action: GARDASIL contains L1 VLPs, which are proteins that resemble wild-type virions. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.
In preclinical studies, induction of anti-papillomavirus antibodies with L1 VLP vaccines resulted in protection against infection. Administration of serum from vaccinated to unvaccinated animals resulted in the transfer of protection against HPV to the unvaccinated animals. These data suggest that the efficacy of L1 VLP vaccines is mediated by the development of humoral immune responses.
Clinical Studies: Prophylactic Efficacy-HPV Types 6, 11, 16, and 18 in 16- Through 26-Year-Old Girls and Women: GARDASIL was highly efficacious in reducing the incidence of cervical, vulvar, and vaginal cancers; CIN (any grade); AIS; non-invasive cervical cancer (CIN 3 and AIS); and external genital lesions, including condyloma acuminata, VIN (any grade) and VaIN (any grade) caused by HPV types 6, 11, 16, and 18. Based on a pre-specified analysis of lesions evident beginning 30 days Postdose 1, there was evidence that the vaccine was already efficacious during the course of the 3-dose vaccination regimen.
The primary analyses of efficacy, with respect to HPV types 6, 11, 16, and 18, were conducted in the per-protocol efficacy (PPE) population, consisting of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naive to the relevant HPV type(s) prior to dose one and through 1 month Postdose 3 (Month 7). Efficacy was measured starting after the Month 7 visit
Pharmacology: Pharmacodynamics: Mechanism of Action: GARDASIL contains L1 VLPs, which are proteins that resemble wild-type virions. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.
In preclinical studies, induction of anti-papillomavirus antibodies with L1 VLP vaccines resulted in protection against infection. Administration of serum from vaccinated to unvaccinated animals resulted in the transfer of protection against HPV to the unvaccinated animals. These data suggest that the efficacy of L1 VLP vaccines is mediated by the development of humoral immune responses.
Clinical Studies: Prophylactic Efficacy-HPV Types 6, 11, 16, and 18 in 16- Through 26-Year-Old Girls and Women: GARDASIL was highly efficacious in reducing the incidence of cervical, vulvar, and vaginal cancers; CIN (any grade); AIS; non-invasive cervical cancer (CIN 3 and AIS); and external genital lesions, including condyloma acuminata, VIN (any grade) and VaIN (any grade) caused by HPV types 6, 11, 16, and 18. Based on a pre-specified analysis of lesions evident beginning 30 days Postdose 1, there was evidence that the vaccine was already efficacious during the course of the 3-dose vaccination regimen.
The primary analyses of efficacy, with respect to HPV types 6, 11, 16, and 18, were conducted in the per-protocol efficacy (PPE) population, consisting of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naive to the relevant HPV type(s) prior to dose one and through 1 month Postdose 3 (Month 7). Efficacy was measured starting after the Month 7 visit
Gardasil quadrivalent HPV (Types 6,11,16,18) vaccineHPV ဗိုင်းရပ်စ်ပိုးကြောင့်ဖြစ်သော သားအိမ်ခေါင်းကင်ဆာ၊ စအို ကင်ဆာ၊ လည်ချောင်းကင်ဆာ၊လိင်တံကင်ဆာကာကွယ်ဆေး
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