Immunogenicity and safety of DTaP/Hib combined vaccination at different inoculation sites among infants
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摘要:
目的 评价无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP/Hib)不同部位接种后的安全性和免疫原性。 方法 2015年9月 — 2016年3月在福建省南平市选择3月龄婴儿入组164名,于3、4、5月龄共接种3剂次针次DTaP/Hib疫苗。接种疫苗后对所有受试者进行不良反应的随访观察,并采集受试者免疫前和基础免疫后28 d的血清样本,进行免疫原性观察。 结果 不同接种部位接种DTaP/Hib疫苗后受试者不良反应发生率均较低,且无显著性差异。除白喉抗体的几何平均增长倍数(GMI)大腿组高于臀部组外,其余抗体的阳性率、阳转率、几何平均浓度(GMC)、GMI组间比较,差异均无统计学意义。 结论 上臂三角肌、大腿前外侧和臀部均可以作为接种部位,接种部位不同不影响DTaP/Hib疫苗的安全性和免疫原性。 Abstract:Objective To evaluate the immunogenicity and safety of a diphtheria-tetanus-acellular pertussis and Haemophilus influenzae type b (DTaP/Hib) combined vaccination at different inoculation sites. Methods From September 2015 to March 2016 in Nanping city of Fujian province, China, a total of 164 infants aged 3 months were enrolled and assigned into three groups randomly for inoculations with 3 doses of the DTaP/Hib combined vaccine at 3-, 4-, and 5-month of age at three injection sites including deltoid muscle of upper arm, anterolateral thigh muscle and gluteal muscle. Follow-up observations on adverse effects after each dose of the vaccinations were conducted among all the infants and blood samples were collected before the first dose and 28 days after basic immunization for the detection on immunogenicity. Results The incidence of adverse reactions was low after inoculations of DTaP/Hib combined vaccine at the three different injection sites, and there was no significant difference in the incidence among the infants of the three groups; there were also no significant disparities in positive rate, seroconversion rate, geometric mean concentration and geometric mean increase (GMI) for antibodies among the three groups, except for an observed higher GMI of diphtheria antibody in the infants with the injections into anterolateral thigh muscle than that in the infants with the injections into gluteal muscle. Conclusion Deltoid muscle of upper arm, anterolateral thigh muscle and gluteal muscle all could be used as injection sites for the inoculation of DTaP/Hib combined vaccine and the injection sites do not affect the immunogenicity and safety of the vaccine. -
表 1 各组征集性不良反应分析
指标 严重程度 上臂组(n = 55) 大腿组(n = 54) 臀部组(n = 54) 统计量 P 值 率(%) 95 % CI 率(%) 95 % CI 率(%) 95 % CI 征集性 合计 1.82 0.05~9.72 0.00 0.00~6.60 1.85 0.05~9.89 Fisher′s 1.0000 1级 0.00 0.00~6.49 0.00 0.00~6.60 0.00 0.00~6.60 2级 0.00 0.00~6.49 0.00 0.00~6.60 1.85 0.05~9.89 Fisher′s 0.6626 3级 1.82 0.05~9.72 0.00 0.00~6.60 0.00 0.00~6.60 Fisher′s 1.0000 全身 合计 1.82 0.05~9.72 0.00 0.00~6.60 1.85 0.05~9.89 Fisher′s 1.0000 局部 合计 0.00 0.00~6.49 0.00 0.00~6.60 0.00 0.00~6.60 表 2 各抗体阳性率和阳转率分析
抗体 指标 上臂组(n = 55) 大腿组(n = 54) 臀部组(n = 54) 统计量 P 值 率(%) 95 % CI 率(%) 95 % CI 率(%) 95 % CI PT 免前阳性率 0.00 0.00~6.49 0.00 0.00~6.60 0.00 0.00~6.60 免后阳性率 98.18 90.28~99.95 100.00 93.40~100.00 98.15 90.11~99.95 Fisher′s 1.0000 阳转率 98.18 90.28~99.95 100.00 93.40~100.00 98.15 90.11~99.95 Fisher′s 1.0000 FHA 免前阳性率 0.00 0.00~6.49 0.00 0.00~6.60 0.00 0.00~6.60 免后阳性率 100.00 93.51~100.00 94.44 84.61~98.84 92.59 82.11~97.94 Fisher′s 0.1003 阳转率 100.00 93.51~100.00 94.44 84.61~98.84 92.59 82.11~97.94 Fisher′s 0.1003 DT 免前阳性率 5.45 1.14~15.12 3.70 0.45~12.75 12.96 5.37~24.90 Fisher′s 0.2113 免后阳性率 100.00 93.51~100.00 100.00 93.40~100.00 98.15 90.11~99.95 Fisher′s 0.6626 阳转率 100.00 93.51~100.00 100.00 93.40~100.00 98.15 90.11~99.95 Fisher′s 0.6626 TT 免前阳性率 5.45 1.14~15.12 12.96 5.37~24.90 5.56 1.16~15.39 Fisher′s 0.2819 免后阳性率 100.00 93.51~100.00 100.00 93.40~100.00 98.15 90.11~99.95 Fisher′s 0.6626 阳转率 100.00 93.51~100.00 100.00 93.40~100.00 98.15 90.11~99.95 Fisher′s 0.6626 Hib 免前阳性率 12.73 5.27~24.48 22.22 12.04~35.60 7.41 2.06~17.89 Chisq = 5.0207 0.0812 免后阳性率 100.00 93.51~100.00 98.15 90.11~99.95 100.00 93.40~100.00 Fisher′s 0.6626 阳转率 96.36 87.47~99.56 88.89 77.37~95.81 100.00 93.40~100.00 Fisher′s 0.0207 上臂组vs大腿组 Fisher′s 0.1614 上臂组vs臀部组 Fisher′s 0.4954 大腿组vs臀部组 Fisher′s 0.0270 表 3 各抗体GMC和GMI水平分析
抗体 指标 上臂组(n = 55) 大腿组(n = 54) 臀部组(n = 54) F 值 P 值 平均值 95 % CI 平均值 95 % CI 平均值 95 % CI PT 免前GMT 6.86 6.19~7.61 5.46 4.89~6.10 6.25 5.67~6.90 4.9313 0.0084 SNK分组结果 A B B*A 4.9313 0.0084 免后GMT 101.17 90.88~112.62 96.92 89.44~105.02 94.80 80.11~112.20 0.2870 0.7509 GMI 14.74 12.94~16.79 17.76 15.75~20.02 15.16 12.54~18.34 1.8069 0.1675 FHA 免前GMT 3.48 3.00~4.02 3.02 2.61~3.51 3.30 2.90~3.75 1.0057 0.3681 免后GMT 42.42 38.84~46.34 44.17 39.61~49.26 38.44 34.41~42.93 1.9301 0.1485 GMI 12.20 10.15~14.68 14.61 12.26~17.42 11.65 9.58~14.16 1.6675 0.1920 DT 免前GMT 0.05 0.04~0.06 0.04 0.04~0.05 0.06 0.05~0.06 5.7560 0.0039 SNK分组结果 A B A 5.7560 0.0039 免后GMT 1.75 1.57~1.96 1.90 1.68~2.16 1.72 1.35~2.18 0.4204 0.6575 GMI 35.14 29.27~42.18 46.84 38.99~56.28 30.95 24.05~39.83 4.1508 0.0175 SNK分组结果 B*A A B 4.1508 0.0175 TT 免前GMT 0.04 0.04~0.05 0.06 0.05~0.06 0.05 0.04~0.06 4.1729 0.0171 SNK分组结果 B A B*A 4.1729 0.0171 免后GMT 4.91 4.69~5.15 5.22 5.01~5.45 4.72 3.77~5.92 0.5636 0.5703 GMI 117.41 100.01~137.84 93.10 79.94~108.43 95.74 73.43~124.83 1.6382 0.1976 Hib 免前GMT 0.11 0.08~0.15 0.17 0.11~0.26 0.09 0.07~0.12 2.8671 0.0598 免后GMT 7.06 6.03~8.28 9.13 6.79~12.27 9.22 7.42~11.46 1.7422 0.1784 GMI 63.99 47.02~87.09 55.04 34.65~87.44 100.07 75.49~132.64 2.9951 0.0528 注:A高于B,有统计学差异;B*A为介于A组和B组之间,与A组和B组无统计学差异。 -
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