根据 0-6 月免疫程序，对 9-10 岁女童同时接种或间隔一个月分别接种四价 HPV 疫苗和甲型肝炎乙型肝炎联合疫苗的免疫原性。
Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9-10 year-old girls according to 0-6 month schedule.
机构信息
a Quebec Public Health Institute; Québec, Canada.
出版信息
Hum Vaccin Immunother. 2014;10(8):2438-45. doi: 10.4161/hv.29617.
BACKGROUND
No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine (qHPV-Gardasil®) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine (Twinrix-Junior®). Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines.
OBJECTIVES
To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered (Group-Co-adm) or given one month apart (Group-Sep) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups.
METHODS
416 9-10 year-old girls were enrolled. Vaccination schedule was 0-6 months. Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose. Anti-HPV were measured 6 months post-first dose in Group-Co-adm and in all subjects 1 and 36 months post-second dose.
RESULTS
Six months post-first dose: 100% of subjects had detectable anti-HAV and 56% and 73% had detectable anti-HBs in Group-Co-Adm and Group-Sep, respectively. In Group-Co-adm 94, 100, 99 and 96% had detectable antibodies to HPV 6, 11, 16 and 18, respectively. One month post-second dose of qHPV and HAV/HBV vaccine, in both study groups 99.5-100% of subjects had an anti-HAV titer ≥ 20IU/L, 97.5-97.6% an anti-HBs level ≥ 10IU/L, and 100% had an anti-HPV titer ≥ 3LU. Thirty-six months post-second dose of qHPV all but four subjects (99%) had antibodies to HPV18 and 100% had antibodies to HPV6, 11 and 16. The great majority (97-100%) had an anti-HPV titer ≥ 3 LU. Post-second dose administration of qHPV and HAV/HBV, no meaningful difference was observed in the immune response in the two study groups to any component of vaccines.
CONCLUSIONS
The results indicate that qHPV and HAV/HBV can be given during the same vaccination session. Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response. Three years post-second dose of qHPV, the great majority of subjects had antibodies to HPV types included in the vaccine. A two-dose schedule for pre-adolescents might be a reasonable alternative to the currently approved three-dose schedules.
背景
尚未有研究报告单剂四价人乳头瘤病毒（HPV）疫苗（加德西®）接种后的免疫原性，也无该疫苗与甲型肝炎/乙型肝炎联合疫苗（双福立适®）同时接种的相关数据。两项上市前研究报告称，当 HPV 疫苗和 HBV 疫苗联合接种时，抗 HPV 抗体滴度相似，但抗 HBs 抗体滴度较低。
目的
评估四价 HPV 疫苗和甲型肝炎/乙型肝炎联合疫苗同时接种（联合组）或间隔一个月接种（间隔组）的免疫原性，并测量两组研究对象在接种四价 HPV 疫苗第二针后 3 年 HPV 抗体的持久性。
方法
416 名 9-10 岁女孩入组。接种方案为 0-6 个月。所有受试者在首针后 6 个月和第二针后 1 个月测量抗-HAV 和抗-HBs。联合组在首针后 6 个月和所有受试者在第二针后 1 个月和 36 个月测量抗-HPV。
结果
首针后 6 个月：联合组和间隔组分别有 100%和 56%、73%的受试者可检测到抗-HAV，94%、100%、99%和 96%的受试者可检测到 HPV 6、11、16 和 18 的抗体。首针后 1 个月接种 qHPV 和 HAV/HBV 疫苗后，两组研究对象均有 99.5-100%的受试者抗-HAV 滴度≥20IU/L，97.5-97.6%的受试者抗-HBs 水平≥10IU/L，100%的受试者抗-HPV 滴度≥3LU。接种 qHPV 疫苗第二针后 36 个月，除 4 名（99%）受试者外，所有受试者均有 HPV18 抗体，100%的受试者有 HPV6、11 和 16 抗体。绝大多数（97-100%）受试者的抗-HPV 滴度≥3LU。接种 qHPV 和 HAV/HBV 第二针后，两组研究对象对疫苗各成分的免疫应答无明显差异。
结论
结果表明，qHPV 和 HAV/HBV 可在同一接种程序中接种。两剂 qHPV 和 HAV/HBV 疫苗可诱导强烈的免疫应答。接种 qHPV 疫苗第二针后 3 年，绝大多数研究对象仍有 HPV 疫苗所含类型的抗体。对于青少年，两剂接种方案可能是替代目前批准的三剂接种方案的合理选择。
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