国产流感裂解疫苗的免疫效果及安全性观察

我国是流感的高发区,每年均有不同程度流行,严重威胁人民健康.接种流感疫苗是预防流感的最佳方法.安全性、免疫原性较好的疫苗将成为未来流感疫苗的发展方向.为了解国产流感病毒裂解疫苗在人群中接种的安全性和免疫效果,并与同类进口流感疫苗做对比,于2006年11月至2007年4月在陕西省屑县进行临床研究,结果报告如下.     

流行性感冒裂解疫苗安尔来福TM的安全性和免疫原性研究

目的为了评价3价流行性感冒(流感)裂解疫苗安尔来福TM的安全性和免疫原性.方法于2003年6～11月在广西壮族自治区南宁市和柳城县进行以进口同类疫苗为对照的临床研究.受试者为＞6个月～＞60岁健康人群1 332人,接种疫苗后对受试者进行不良反应观察,应用微量血凝抑制(HI)试验对受试者血清进行抗体分型检测.结果试验疫苗组与对照疫苗组各有1例出现接种部位红肿,均在72h内消失;试验组与对照组发热反应率分别为3.21%(35/1 092)、6.25%(15/240),差异有显著的统计学意义.未见其它不良反应发生.试验组和对照组各有734人和163人检测了HI抗体,结果各型HI抗体总阳转率分别为50.0%～84.2%和57.7%～84.0%,抗体几何平均滴度分别增长4.2～11.4倍和5.7～11.6倍,差异均无显著的统计学意义.结论试验疫苗的免疫效果达到欧盟标准,表明流感裂解疫苗安尔来福TM的安全性、免疫原性良好,适于推广使用.     

老年人接种三价流感病毒裂解疫苗的免疫原性评价

目的 分析宁波市江北区老年人群流感病毒免疫水平及接种三价流感病毒裂解疫苗(TIV)后的免疫原性,为促进老年人群流感疫苗接种提供依据.方法 于2020年9-11月在宁波市江北区招募≥60岁老年人为调查对象,根据接种意向分别纳入接种组和对照组.采用微量血凝抑制试验测定受试前和受试后30 d A(H1N1)、A(H3N2)和...     

国产流感裂解疫苗接种人体后安全性和免疫原性评价

目的:评价变更后流感毒株生产的国产流感裂解疫苗安全性和免疫原性。方法:对宁波市宁海县559例分组接种流感裂解疫苗者进行临床指标(局部反应、全身反应)的监测,并抽取其中213例,用流感病毒HI抗体测定法对接种者免疫前后的抗体滴度进行测定,比较免疫前后抗体阳转率及几何平均滴度(GMT)。结果:观察对象接种疫苗后发热反应发生率为1.22%,全身其他反应发生率为1.22%,局部反应发生率为1.07%,且以轻度反应为主。H1N1型、H3N2型、B型免后抗体阳转率分别为84.04%、85.45%、83.57%;不同年龄组免后抗体滴度的增长倍数,H1N1型在5.50～16.00倍之间,H3N2型在13.16～39.33倍之间,B型在7.28～24.85倍之间,各年龄组各抗体型别免疫前后GMT差别均有统计学意义。结论:国产流感裂解疫苗具有良好的安全性和免疫原性。     

人群接种流感裂解疫苗的安全性评价

目的：对人群接种流感裂解疫苗的安全性进行评价。方法：对国产和进口的流感裂解疫苗进行接种副反应调查。结果：对90120名接种对象的副反应调查表明，流感裂解疫苗疫苗的接种副反应发生率为69．9／10万，2种进口疫苗和1种国产疫苗的副反应发生率分别为46．5／10万、52．8／10万和212．9／10万，进口疫苗之间副反应发生率无显著性差异，而国产和进口疫苗的副反应发生率有显著性差异。排前3位的副反应症状为发热、局部红肿和皮疹，发生率分别为27．7／10万、17．7／10万和7．8／10万。所有报告病例均为非严重性，全部病例均在短时间内恢复正常，无严重接种副反应发生。结论：本调查结果表明流感裂解疫苗的副反应发生率低且反应轻微，安全性较高，可用于人群的大规模预防接种及疫情应急接种。     

几种重要传染病疫苗的研究现状

疫苗接种是预防和控制传染病发生和流行的重要手段，对传染病疫苗的研究开发是实现传染病防治的重要保障。本文对鼠疫、疟疾、登革热、霍乱、伤寒、流感等几种重要传染病的疫苗研究进展情况进行保护性、安全性、免疫原性和接种途径等方面的综述。     

流行性感冒灭活亚单位疫苗和裂解疫苗的安全性和免疫原性的比较研究

目的：比较流感亚单位疫苗与裂解疫苗的安全性和免疫原性。方法：流感亚单位疫苗和裂解疫苗按随机双盲法分别接种249名和250名6～12岁健康儿童。于接种当日和接种后3天内观察局部反应和全身反应。用血凝抑制试验检测接种儿童免疫前后的血凝抑制抗体(HI)滴度，计算抗体4倍增长阳转率，免疫后的保护水平抗体(≥1：40)的免疫成功率，以及抗体几何平均滴度((GMT)值和增长倍数。比较流感亚单位疫苗和裂解疫苗的临床观察结果。结果：两种疫苗接种后均未见局部反应，发热反应率和中高度发热反应率亚单位疫苗低于裂解疫苗，两组的差异有显著的统计学意义。未见其他全身反应。对疫苗3个毒株的血清学检测结果显示：亚单位疫苗的阳转率为74．5％～95．1％，保护水平抗体的免疫成功率为94．2％～99．6％，抗体GMT增长倍数为5．4～21．2。裂解疫苗的阳转率为79．8％～97．8％，保护水平抗体的免疫成功率为96．4％～100．0％，抗体GMT、增长倍数为6．4～21．0。两种疫苗的免疫学效果相似，所见差异无显著的统计学意义。结论：流感亚单位疫苗和裂解疫苗接种6～12岁儿童后反应轻微，安全性良好，亚单位疫苗发热反应率低于裂解疫苗。两种疫苗的免疫原性良好，具有同样显著的免疫效果，可以推广使用。     

集居人群流感疫苗不同接种覆盖率的保护效果评价

目的研究集体居住生活人群季节性流感疫苗的保护效果。方法按流感疫苗接种覆盖率将7家企业集体居住人群划分为A、B和C组,比较3组的流感发病率及组内接种与未接种人群的发病率,并计算各组疫苗保护率。结果 A、B和C组企业职工流感疫苗接种覆盖率分别为30.60%、64.69%和80.64%,疫苗接种后1年内甲型流感发病率分别为57.28‰、25.37‰和8.60‰,均低于接种前2年发病率;3组免后1年内发病率进行两两比较,差异均有统计学意义(P0.01),甲型流感年发病率随接种覆盖率增高而降低(P0.05)。A、B、C组职工免后1年内的疫苗保护率及95%可信区间分别为61.93%(46.63%~72.85%)、86.51%(78.57%~91.50%)和86.22%(79.18%~90.88%);B组和C组的疫苗保护率均高于A组。结论接种季节性流感疫苗对预防流感效果明显;在集体居住生活人群中,提高疫苗接种覆盖率可提高疫苗保护率。     

流行性感冒疫苗的安全性和免疫原性观察

为了解流行性感冒（流感）疫苗，尤其是儿童剂型流感疫苗的安全性和免疫原性，于1999年末在天津市对防感灵的儿童剂型和成人剂型进行了接种后安全性和免疫原性观察，共观察25～55岁成人53名和6月龄～3岁儿童69名。结果表明副反应发生率分别为3.8％和8.7％；抗体阳转率分别为92.2％、85.8％。证实防感灵疫苗儿童剂型和成人剂型均具有良好的免疫原性和安全性。     

国产流行性感冒疫苗安全性和免疫原性在接种前后的比较

为了观察流感裂解疫苗的安全性和免疫效果,为人群接种流行性感冒（流感）疫苗提供科学依据,我们对上海生物制品研究所的流感裂解疫苗进行了临床观察和评价.     

国产血源性乙肝疫苗减量接种的远期效果评价

采用随机、双盲和有安慰剂对照的现场实验,对国产血源性乙肝疫苗减量接种的远期效果进行了观察。结果表明乙肝疫苗减量与常规剂量接种虽可产生基本相同的免疫学效果,但从保护效价和有效比率来看,减量接种的远期流行病学效果则不如常规剂量接种显著;乙肝疫苗的保护效果主要取决于接种后抗HBsGMT的高低和接种剂量,似受抗HBs应答率影响较小。     

Effect of timing of hepatitis B vaccine doses on response to vaccine in Yucpa Indians

In a large hepatitis B prevention programme, hepatitis B vaccine was given in standard doses to greater than 1000 susceptible Yucpa Indians between 1983 and 1985. Thirteen months after the programme began, 373 vaccine recipients were tested using commercial radioimmunoassay to titre antibody response to the vaccine. Because of logistic difficulties, only 32% had received vaccine by the recommended schedule (second and third doses at one and six months after the first, respectively). The second and third doses were received early by 4 and 31%, respectively, and 27 and 16% received these doses later than intended. Overall response to vaccine was excellent: 98% of vaccinees developed anti-HBs greater than 10 mIU (geometric mean titre 688 mIU). Multivariate analysis showed that the response to vaccination was inversely related to the age of the vaccinee and directly related to the timing of the third vaccine dose. In particular, those receiving the third vaccine dose late (greater than 7 months after the first dose) developed antibody titres two-fold higher than those receiving the third dose on schedule (p less than 0.01). The response to vaccination was not significantly related to the timing of the second dose. A satisfactory response was obtained with various schedules of dose timing, including early second and third doses, late second and third doses and late second but normal third doses. These findings suggest that the response to hepatitis B vaccine is not highly dependent on timing of vaccine doses and that modest alterations in timing of doses, such as those necessary to integrate hepatitis B vaccine with other childhood vaccines, do not affect the excellent response to this vaccine.     

新疆维吾尔自治区2016－2017年免疫规划疫苗损耗调查

目的 了解新疆维吾尔自治区预防接种单位免疫规划（EPI）疫苗的损耗现状，为进一步精细化管理和使用EPI疫苗提供依据。方法 采取分层整群抽样方法抽取135个接种单位，调查2016-2017年6种EPI疫苗接种和使用数据，包括常规免疫和脊髓灰质炎疫苗群体性补充免疫活动中疫苗领发和使用数量、疫苗报废记录，以及接种单位的地区类型、服务模式、接种周期、日均接种量等。采用描述流行病学方法计算和分析疫苗的损耗系数。结果 单人份的无细胞百白破联合疫苗（DTaP）和三价脊髓灰质炎减毒活疫苗（tOPV）损耗系数最低，分别为1.00和1.02；多人份的二价脊髓灰质炎减毒活疫苗（bOPV）、A群脑膜炎球菌多糖疫苗（MPV-A）、白喉破伤风联合疫苗（DT）、卡介苗（BCG）损耗系数分别为1.58、1.67、1.68、3.02。城市、农村、牧区接种单位EPI疫苗损耗系数范围分别为1.00~2.84、1.00~3.71、1.00~2.27；乡级集中、村级集中、分散接种模式的损耗系数分别为1.00~3.00、1.00~4.41、1.00~1.94。接种周期越长或日均接种量越小，损耗系数越大。结论 新疆维吾尔自治区预防接种单位多人份EPI疫苗损耗较高，并受地区和接种服务形式的影响。需根据地区类型、接种单位服务形式等加强精细化的疫苗管理，减少疫苗损耗和浪费。     

Serologic response to oral polio vaccine and enhanced-potency inactivated polio vaccines

In a randomized, controlled trial carried out from November 1980 to July 1983 involving 1,114 infants in Baltimore City and in Baltimore and Prince George's counties, Maryland, the serologic response to three doses of two enhanced-potency inactivated polio vaccines was compared with the response to three doses of oral polio vaccine. The mean ages at vaccination were 2.2, 4.7, and 19.9 months, respectively, for the three doses. Seroconversion after the first dose varied from 35% to 84%, and it was higher after oral polio vaccine than after either of the enhanced-potency inactivated polio vaccines for polioviruses types 2 and 3. Approximately two and one-half and 16 months after the second dose, almost all inactivated polio vaccine recipients had antibodies against all three virus types (98-100%). Fewer oral polio vaccine recipients had detectable antibodies to type 1 (89-92%) and to type 3 (96%). After three doses of vaccine, all children had antibodies against types 2 and 3. Approximately 1% of the inactivated polio vaccine recipients and 3% of the oral polio vaccine recipients lacked antibody to type 1. One or two doses of oral polio vaccine stimulated higher reciprocal geometric mean antibody titers against type 2 poliovirus than did the inactivated polio vaccine. For the other two types, the results were mixed. The third dose of inactivated polio vaccine produced significant increases in the reciprocal geometric mean titers against each of the three poliovirus types and resulted in significantly higher reciprocal geometric mean titers after three doses of vaccine for recipients of inactivated polio vaccine than for recipients of oral polio vaccine.     

Dose-specific efficacy of Haemophilus influenzae type b conjugate vaccines: a systematic review and meta-analysis of controlled clinical trials

Global coverage of infant Haemophilus influenzae type b (Hib) vaccination has increased considerably during the past decade, partly due to GAVI Alliance donations of the vaccine to low-income countries. In settings where large numbers of children receive only one or two vaccine doses rather than the recommended three doses, dose-specific efficacy estimates are needed to predict impact. The objective of this meta-analysis is to determine Hib vaccine efficacy against different clinical outcomes after receiving one, two or three doses of vaccine. Studies were eligible for inclusion if a prospective, controlled design had been used to evaluate commercially available Hib conjugate vaccines. Eight studies were included. Pooled vaccine efficacies against invasive Hib disease after one, two or three doses of vaccine were 59%, 92% and 93%, respectively. The meta-analysis provides robust estimates for use in decision-analytical models designed to predict the impact of Hib vaccine.     

中国2013年第二类疫苗接种情况监测分析

目的分析中国（未包括香港、澳门特别行政区和台湾地区,下同）2013年第二类疫苗接种情况。方法从中国免疫规划监测信息管理系统中提取2013年1-12月全国各乡[镇、街道、苏木、新疆生产建设兵团（新疆兵团）团场,下同]级单位每月报告的第二类疫苗接种报表,采用描述流行病学方法进行分析。结果2013年,除西藏自治区外的31个省（自治区、直辖市、新疆兵团,下同）报告了第二类疫苗接种情况。县（区、市、旗、新疆兵团师,下同）级单位报告完整率为85.90%,乡级单位报告完整率为83.12%。全国2013年报告接种第二类疫苗共32种,93 493 683剂,全国平均接种剂次为690.48剂/万人。人均接种量最多的为上海市（2670.21剂/万人）,人均接种量最少的为青海省（110.4剂/万人）。接种量最多的前三种疫苗分别是人用狂犬病疫苗、b型流行性感冒（流感）嗜血杆菌多糖结合疫苗（Haemophilus Influenzae Type b Polysaccharide Conjugate Vaccine,Hib）、流感疫苗。3个省使用第二类疫苗种类≥30种。分析儿童常用5种第二类疫苗接种特点,其中Hib的接种量最多（1400万剂）;水痘减毒活疫苗的估算接种率最高（57.96%）;灭活脊髓灰质炎疫苗的接种量相对较低。结论通过第二类疫苗接种情况报告系统可有效收集、分析全国第二类疫苗接种情况,但需进一步完善中国第二类疫苗的监测报告。     

The protective effect of the large-scale use of PHKC rabies vaccine in humans in China

Reported are the results obtained with different immunization schedules of adjuvant or freeze-dried concentrated (FDC) primary hamster kidney cell (PHKC) rabies vaccine on volunteers. The FDC vaccine (potency, 4.5 IU), which was inoculated in six doses, on days 0, 3, 7, 14, 30 and 90, and the adjuvant vaccine (potency 2.5 IU), which was inoculated in five doses, on days 0 and 7 (double dose), 14, 30 and 90, induced earlier, higher, and more persistent neutralizing antibody titres than the adjuvant vaccine which was inoculated in five doses on days 0, 3, 7, 14 and 30. The persistence of the neutralizing antibody titres induced by three intradermal doses of vaccine administered on days 0 (4 sites), 7 (2 sites), and 28 (1 site) was lower than that induced by six intramuscular doses administered on days 0, 3, 7, 14, 30, and 90. A cell-mediated immunity (CMI) was also induced in vaccinees who received the adjuvant vaccine. The protective effect of the adjuvant vaccine was better than that of the previously used Semple vaccine and has had a positive effect on the epidemiology of human rabies in China.     

Strength and durability of antibody responses to BNT162b2 and CoronaVac

We studied 2780 adults in Hong Kong who received CoronaVac inactivated virus vaccine (Sinovac) and BNT162b2 mRNA vaccine (“Comirnaty”, BioNTech/Fosun Pharma). We compared rates of antibody waning over time using an enzyme-linked immunosorbent assay for spike receptor binding domain and a surrogate virus neutralization test. We found stronger and more durable antibody responses to two doses of the mRNA vaccine, and slightly stronger initial antibody responses to each vaccine in younger adults and women. The weaker and less durable responses following CoronaVac support earlier provision of third doses to persons who previously received two doses of this vaccine.     

COVID-19 vaccine express strategy in Malawi: An effort to reach the un-reach

ObjectivesTo establish the impact of “Covid-19 Vaccination express” (CVE) on vaccine uptake in Malawi.DesignRetrospective cross-sectional study to compare the daily vaccine administration rate in CVE and routine covid vaccination (RCV). RCV data was collected from March 2021 to October 2021. The data regarding CVE was collected from 5 November 2021 to 31 December 2021. Data was collected regarding (1) the total number and type of vaccine doses administered and (2) Demographic details like age, gender, occupation, presence of comorbidities, the first dose, or the second dose of the people who received a vaccine.ResultsFrom March-December 2021, a total of 1,866,623 COVID-19 vaccine doses were administered, out of which 1,290,145 doses were administered at a mean daily vaccination rate of 1854 (95 % CI: 1292–2415) doses as a part of RCV, and 576,478 doses were administered at a mean daily vaccination rate of 3312 (95 % CI: 2377–4248) doses as a part of CVE.Comparing the mean daily doses (Astra Zeneca, AZ doses 1 & 2) administered in the CVE and RCV showed that the mean daily doses of AZ vaccine administered were significantly higher in the CVE (p < 0.05).ConclusionCVE successfully increased the uptake of the Covid-19 vaccine.     

中国2010-2012年水痘减毒活疫苗上市后安全性监测分析

目的分析中国2010-2012年水痘减毒活疫苗（Varicella Attenuated Live Vaccine,VarV）上市（未包括香港、澳门特别行政区和台湾地区,下同）后,疑似预防接种异常反应（Adverse Events Following Immunization,AEFI）的发生特征,评价VarV预防接种的安全性。方法通过中国AEFI信息管理系统,收集截至2013年4月18日报告的2010~2012年VarV发生的AEFI个案数据,采用描述流行病学方法进行分析。结果中国AEFI信息管理系统共收到2010~2012年接种VarV发生的AEFI个案4329例,根据中国免疫规划信息管理系统中VarV接种剂次估算,报告发生率为19.16/10万剂。其中严重AEFI 101例,估算报告发生率为0.45/10万剂。不良反应4138例,估算报告发生率为18.31/10万剂;其中一般反应15.16/10万剂,异常反应3.15/10万剂。所有AEFI中,男、女性别比为1.37∶1;主要集中在≤3岁儿童和首剂接种后。在不良反应中,一般反应的主要症状为发热、局部红肿和局部硬结,异常反应的诊断主要为过敏性皮疹。不良反应集中在接种后≤1d。所有严重异常反应均治愈和好转。结论 VarV的不良反应报告发生率在预期范围内,与其他国家类似,但仍需关注预防接种后急性过敏性反应的发生情况。