微生物学免疫学进展
微生物學免疫學進展
미생물학면역학진전
PROGRESS IN MICROBIOLOGY AND IMMUNOLOGY
2015年
5期
1-6
,共6页
闫绍宏%陈平纡%马俊清%武贵森%许建斌%顾苏仪%徐冬冬%邹勇
閆紹宏%陳平紆%馬俊清%武貴森%許建斌%顧囌儀%徐鼕鼕%鄒勇
염소굉%진평우%마준청%무귀삼%허건빈%고소의%서동동%추용
甲型H1 N1流感病毒%疫苗%临床试验,安全性%免疫原性
甲型H1 N1流感病毒%疫苗%臨床試驗,安全性%免疫原性
갑형H1 N1류감병독%역묘%림상시험,안전성%면역원성
Influenza A H1N1 virus%Vaccine%Clinical trail%Safety%Immunogenicity
目的：评价甲型H1N1流感病毒裂解疫苗（简称甲型H1N1流感疫苗）的免疫原性和安全性。方法按照随机、双盲、安慰剂对照的原则，采用0、21天免疫程序，选择3岁及3岁以上健康者1202人。分组为3～11岁、12～17岁、≥60岁组，按照人数基本为1∶1的比例随机分别接种7．5μg和15．0μg 甲型H1N1流感疫苗；18～59岁组按照人数基本为1∶1∶1的比例随机分别接种7．5μg、15．0μg甲型 H1 N1流感疫苗和安慰剂对照。观察各组接种后的不良反应率以及免疫前后血凝抑制（ HI）抗体阳转率、保护率、GMT水平和平均增长倍数。结果受试对象的安全性结果显示7．5μg和15．0μg组不良反应发生率分别为8．74％（48／549）和13．88％（74／533），其中Ⅱ级反应率分别为03．6％（2／549）和1．13％（6／533），未观察到Ⅲ级及以上不良反应和其他异常反应及严重不良事件。2剂接种未见不良反应叠加现象。7．5μg或15．0μg试验疫苗首剂免疫后，血清抗体阳性率分别为85．13％（395／464）和90．77％（413／455），保护率分别为85．56％（397／464）和91．43％（416／455），抗体GMT较免疫前分别增长36．1倍和526．倍。2剂免疫后，血清抗体阳性率分别是97．84％（454／464）和99．12％（451／455），保护率分别是98．06％（455／464）和99．56％（453／455），抗体GMT较免疫前分别增长63．3倍和96．0倍。4个年龄组（3～11岁、12～17岁、18～59岁及≥60岁年龄组）7．5μg和15．0μg组HI抗体阳性率和保护率均大于70％，GMT较免疫前均增长2．5倍以上，结果显示7．5μg和15．0μg甲型H1N1流感疫苗接种1剂后抗体水平已达到研究方案中设定的预期标准，免疫2剂后抗体阳性率和抗体水平明显提高。结论临床试验表明甲型H1 N1流感疫苗具有良好的安全性和免疫原性，且接种1剂15．0μg甲型H 1N1流感疫苗，即可在3岁和3岁以上人群中产生良好的免疫效果。
目的：評價甲型H1N1流感病毒裂解疫苗（簡稱甲型H1N1流感疫苗）的免疫原性和安全性。方法按照隨機、雙盲、安慰劑對照的原則，採用0、21天免疫程序，選擇3歲及3歲以上健康者1202人。分組為3～11歲、12～17歲、≥60歲組，按照人數基本為1∶1的比例隨機分彆接種7．5μg和15．0μg 甲型H1N1流感疫苗；18～59歲組按照人數基本為1∶1∶1的比例隨機分彆接種7．5μg、15．0μg甲型 H1 N1流感疫苗和安慰劑對照。觀察各組接種後的不良反應率以及免疫前後血凝抑製（ HI）抗體暘轉率、保護率、GMT水平和平均增長倍數。結果受試對象的安全性結果顯示7．5μg和15．0μg組不良反應髮生率分彆為8．74％（48／549）和13．88％（74／533），其中Ⅱ級反應率分彆為03．6％（2／549）和1．13％（6／533），未觀察到Ⅲ級及以上不良反應和其他異常反應及嚴重不良事件。2劑接種未見不良反應疊加現象。7．5μg或15．0μg試驗疫苗首劑免疫後，血清抗體暘性率分彆為85．13％（395／464）和90．77％（413／455），保護率分彆為85．56％（397／464）和91．43％（416／455），抗體GMT較免疫前分彆增長36．1倍和526．倍。2劑免疫後，血清抗體暘性率分彆是97．84％（454／464）和99．12％（451／455），保護率分彆是98．06％（455／464）和99．56％（453／455），抗體GMT較免疫前分彆增長63．3倍和96．0倍。4箇年齡組（3～11歲、12～17歲、18～59歲及≥60歲年齡組）7．5μg和15．0μg組HI抗體暘性率和保護率均大于70％，GMT較免疫前均增長2．5倍以上，結果顯示7．5μg和15．0μg甲型H1N1流感疫苗接種1劑後抗體水平已達到研究方案中設定的預期標準，免疫2劑後抗體暘性率和抗體水平明顯提高。結論臨床試驗錶明甲型H1 N1流感疫苗具有良好的安全性和免疫原性，且接種1劑15．0μg甲型H 1N1流感疫苗，即可在3歲和3歲以上人群中產生良好的免疫效果。
목적：평개갑형H1N1류감병독렬해역묘（간칭갑형H1N1류감역묘）적면역원성화안전성。방법안조수궤、쌍맹、안위제대조적원칙，채용0、21천면역정서，선택3세급3세이상건강자1202인。분조위3～11세、12～17세、≥60세조，안조인수기본위1∶1적비례수궤분별접충7．5μg화15．0μg 갑형H1N1류감역묘；18～59세조안조인수기본위1∶1∶1적비례수궤분별접충7．5μg、15．0μg갑형 H1 N1류감역묘화안위제대조。관찰각조접충후적불량반응솔이급면역전후혈응억제（ HI）항체양전솔、보호솔、GMT수평화평균증장배수。결과수시대상적안전성결과현시7．5μg화15．0μg조불량반응발생솔분별위8．74％（48／549）화13．88％（74／533），기중Ⅱ급반응솔분별위03．6％（2／549）화1．13％（6／533），미관찰도Ⅲ급급이상불량반응화기타이상반응급엄중불량사건。2제접충미견불량반응첩가현상。7．5μg혹15．0μg시험역묘수제면역후，혈청항체양성솔분별위85．13％（395／464）화90．77％（413／455），보호솔분별위85．56％（397／464）화91．43％（416／455），항체GMT교면역전분별증장36．1배화526．배。2제면역후，혈청항체양성솔분별시97．84％（454／464）화99．12％（451／455），보호솔분별시98．06％（455／464）화99．56％（453／455），항체GMT교면역전분별증장63．3배화96．0배。4개년령조（3～11세、12～17세、18～59세급≥60세년령조）7．5μg화15．0μg조HI항체양성솔화보호솔균대우70％，GMT교면역전균증장2．5배이상，결과현시7．5μg화15．0μg갑형H1N1류감역묘접충1제후항체수평이체도연구방안중설정적예기표준，면역2제후항체양성솔화항체수평명현제고。결론림상시험표명갑형H1 N1류감역묘구유량호적안전성화면역원성，차접충1제15．0μg갑형H 1N1류감역묘，즉가재3세화3세이상인군중산생량호적면역효과。
Objective To evaluate the safety and immunogenicity of pandemic influenza A (H1N1)vaccines.Methods Based on a random, double blind trial with a placebo as a cotrol, a total of 1 202 healthy individuals with an age ≥three years were divided into groups as 3 to 11 years of age ,12 to 17 years of age , and ≥60 years of age group, separately. 7.5 μg or 15.0 μg of influenza A (H1N1)vaccines were injected into subjects in above three groups separately and ran-domly, with a basic propotion (1 ∶1) for two parts of subjects.7.5μg or 15.0μg of influenza A (H1N1)vaccine or steri-lized water for injection as a placebo were injected into subjects in group for 18 to 59 years of age, separately and randomly, with a basic propotion (1 ∶1 ∶1) for three parts of subjects.The observation was carried out in total adverse reaction, and two doses, HI antibody positive conversion rate, protection rate( HI antibody≧1 ∶40), geometric mean titer (GMT) and its increased average times before and after immunization in each group.Results The safety result showed that adverse re-action rate was 8.74%(48/549)and 13.88%(74/533)in the group of 7.5μg and 15.0μg,respectively.Ⅱlevel adverse reaction rate was 0.36%( 2/549 ) and 1.13% ( 6/533 ) respectively, in both parts, and ≥level Ⅲ adverse reaction, other abnormal reaction and serious adverse event did not occur in this trial.There was no overlaping of adverse reaction observed in immunization by the two doses.After immunization by the first dose of 7.5μg and 15μg, HI antibody positive rates were 85.13%(395/464)and 90.77%(413/455), and pro-tection rates were 85.56%(397/464)and 91.43%(416/455),HI antibody titer increased 36.1 times and 52.6 times,re-spectively.After immunization by the two doses, HI antibody positive rates were 97.84%(454/464)and 99.12%(451/455), and protection rates were 98.06%(455/464)and 99.56%(453/455), HI antibody titer increased 63.3 times and 96.0 times.respectively.Both HI antibody positive rate and protection rate were more than 70%, GMT increased by more 3.5 times than before immunization, in 7.5 μg and 15.0 μg parts in all four groups.The results showed that HI antibody reached to the expected level in the designed plan by a single immunization of one of both doses( either 7.5 μg or 15.0μg).Conclusion The clinical trail showed that a single 15.0μg dose of influenza A H1N1 vaccine was able to generate a good immuno response and had a good safety in subjects≥three years of age.
