破伤风-白喉疫苗免疫后成人配方的破伤风-白喉-无细胞百日咳疫苗接种的间隔时间

目前成人配方的破伤风-白喉-无细胞百日咳疫苗(Tdap)已推荐用于预防青少年及成年人百日咳。但如果在接种含有破伤风和白喉类毒素(TD)的疫苗(包括用于婴幼儿的TD或用于大龄儿童和成人的Td)后短期内又接种Tdap就极有可能出现严重的接种部位反应,包括Arthus反应(局部过敏坏死)。为     

百白破三联疫苗无菌性化脓2例报告

吸附百白破三联疫苗(DPT)由百日咳疫苗原液，精制白喉和破伤风类毒素用氢氧化铝吸附制成，每毫升含百日喉菌8个效力单位，精制白喉类毒素20絮状单位，精制破伤风类毒素5絮状单位，其中百日咳疫苗有佐剂作用，可以增强白喉、破伤风类毒素的免疫效果。接种对象为3个月-6周岁儿童作全     

破伤风类毒素-减量白喉类毒素-无细胞百日咳疫苗的应用建议

2019年10月,青少年和成年人免疫实践咨询委员会更新了关于接种破伤风类毒素-减量白喉类毒素-无细胞百日咳（Tdap）疫苗后加强免疫的建议,将此前要求的,使用破伤风类毒素-白喉类毒素（Td）疫苗进行首次接种后每10年加强免疫、伤口处理时预防破伤风、≥7岁且接种史未知/不完整人群的补种,改为可使用Tdap或Td疫苗。此次建议的修改可提高临床即时决策的灵活性。     

婴儿期接种过C群脑膜炎球菌-CRM197结合疫苗的学龄前儿童对白喉的免疫应答和接种反应

C群脑膜炎球菌 ( Men C)结合疫苗于1 999年 1 1月纳入英国常规免疫接种程序 ,大部分 Men C结合疫苗采用与白喉类毒素有密切免疫学相关性的突变体 CRM1 97作为载体蛋白。作者对有或无婴儿期 Men C-CRM1 97结合疫苗接种史儿童 4岁时的白喉抗体水平及相同结合疫苗加强免疫后对白喉的免疫应答进行比较 ,并观察婴儿期接种过多针 Men C结合疫苗的 4岁儿童对 Men C或白喉类毒素疫苗的接种反应。　　 95名婴儿期接种过 0、1、3或 4针 MenC- CRM1 97结合疫苗的儿童分成 4组。第 1组于 2、3、4、1 2月龄接种过 4针 Men C疫苗 ;第 2组于 2、3…     

早产儿对DTaP-乙型肝炎四联疫苗的抗体应答[英]

为了解早产儿接种百日咳无细胞菌苗DTP和乙型肝炎(DTaP-HB)四联疫苗后能否产生较好的抗体应答,作者选择了34名早产儿[孕龄(GA)25～35周]和28名足月儿(GA 38～42周),分别在 3、5、11月龄时接种由SmithKline Beecham公司制造的DTaP-HB四联疫苗.每剂四联疫苗含百日咳类毒素(PT)25μg、丝状血凝素(FHA)25μg、69kDa蛋白8μg、白喉类毒素(DT)25Lf、破伤风类毒素(TT)10Lf和乙型肝炎表面抗原(HBsAg)10μg.免疫后8天内逐日记录临床症状,于第2针和第3针后5～6周采血,观察血清学应答.     

DTPa-HBV和Hib混合疫苗在婴儿中的免疫原性及反应原性[英]

作者采用随机双盲法评价了三批四价白喉-破伤风-无细胞百日咳-乙型肝炎疫苗(DTPa-HBV)与三批b型流感杆菌(Hib)结合苗苗混合后按2、4、6月龄程序接种健康婴儿的免疫原性和反应原性.将269名8～11周龄婴儿随机分为3组,肌肉注射DTPa-HBV/Hib疫苗,后者为每剂0.5ml DTPa-HBV内含25μg百日咳类毒素(PT)、25μg丝状血凝素(FHA)、8μg69kDa外膜蛋白(PRN)、≥30IU白喉类毒素     

含CpG基序的合成ODN的佐剂作用将b型流感杆菌结合疫苗转变为有效的抗多糖和抗载体多价疫苗

已经证实含有未甲基化 Cp G二核苷酸的细菌性 DNA——合成的寡脱氧核苷酸( ODN)能够激活 B细胞、NK细胞以及抗原提呈细胞。当将这种免疫刺激序列 ( ISS)与蛋白质或者肽一起接种实验动物时 ,ISS可作为蛋白佐剂引起 I型免疫应答。作者对 ISS依赖性抗 b型流感杆菌 ( Hib)疫苗载体蛋白抗体的增高是否与保护功能相关进行了讨论。　　将 2 .5μg多糖 ( CHO) -破伤风类毒素( TT)或 CHO-白喉类毒素 ( DT,CRM)单独皮内注射 ,或者与 50μg ISS或不含 ISS的ODN( M- ODN)一起接种雌性 Balb/c或CD1小鼠。 CHO- TT接种 2剂 ,而 CH…     

家属惊厥史与百日咳菌苗的应用

1985年,Stetler等根据美国疾病控制中心(CDC)接种疫苗后不良反应监测系统(MSAEFI)1979～1982年的资料,指出以往有过惊厥史的婴幼儿接种DTP后发生神经系统反应的危险性增加7.2倍,因此,美国免疫实施咨询委员会(ACIP)等建议有惊厥史的儿童可以推迟到确定无进行性神经系统疾病时接种百日咳菌苗.如果发现有进行性神经系统疾病,应禁忌接种百日咳菌苗,但应按现在程序给予全程的白喉和破伤风类毒素混合     

按两种初免程序接种的DTaP-HB疫苗的安全性和免疫原性

作者挑选565名健康婴儿按两种不同初免程序接种百日咳无细胞菌苗DTP-乙型肝炎(DTaP-HB)疫苗,每0.5ml疫苗含25μg百日咳毒素(PT)、25μg丝状血凝素(FHA)、8μg 69kDa蛋白(PRN)、≥30IU白喉类毒素(D)、≥40IU破伤风类毒素(T)、10μg重组乙型肝炎表面抗原(HB)、0.7mg铝盐和2.5mg2-苯氨基乙醇.A组208名6～14周龄婴儿按2、4、6月龄免疫程序接种,B组357名10～16周龄婴儿接3、5、11月龄免疫程序接种.A组婴儿在7月龄、B组婴儿在6和12月龄时采血,用放射免疫法(RIA)测抗-HBs滴度,规定以10IU/ml为界限值;用ELISA测抗-PT、抗-FHA和抗-PRN IgG抗体滴度,规定以5EIU/ml为界限值;用中和试验测抗-D、抗-T滴度,规定以0.01IU/ml为界限值.     

百白破疫苗引起高热反应

患儿男,5月龄。按国家儿童计划免疫程序,于2003年6月13日8:15在医务室进行第3次百白破疫苗接种。接种后,随即到门诊小儿科进行了健康体检,并进行手指血常规化验。中午12:00左右,家长发现患儿全身寒战,儿科医生及时到患儿家中查体。此时患儿体温高达T39.6℃,全身湿热,倦怠、流泪,寒战已消退。给予注射用阿司匹林赖氨酸(来比林),按10～25mg·kg-1,退热,以后每间隔5～6h给予对乙酰氨基酚(百服宁)滴剂0.8ml,2d后痊愈。本次使用的疫苗为吸附百日咳、白喉、破伤风联合疫苗,其组成是由百日咳疫苗原液,精制白喉类毒素及精制破伤风类毒素用氢氧化铝…     

Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States

An investigational combined Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY-TT) has been developed to protect infants from invasive disease caused by Hib and these meningococcal serogroups without adding injections to the immunization schedule. Incorporation of this novel vaccine into the US vaccination schedule will require demonstration of a lack of immunologic interference with other routine pediatric vaccines. This study assessed the immune response to 7-valent pneumococcal conjugate vaccine (PCV7) and combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine (DTaP-HepB-IPV) when separately co-administered with HibMenCY-TT as compared to a US-licensed H. influenzae type b tetanus toxoid conjugate vaccine (Hib-TT) at 2, 4, 6 (N=606) and 12-15 months of age (N=366). HibMenCY-TT was non-inferior to Hib-TT in terms of antibody responses to all Streptococcus pneumoniae serotypes contained in PCV7 and the diphtheria, tetanus, pertussis, hepatitis B and poliovirus antigens contained in DTaP-HepB-IPV one month after the third vaccine dose, and the anti-tetanus geometric mean antibody concentration (GMC) was significantly higher in the HibMenCY-TT group than in the Hib-TT group. In an exploratory analysis, no significant differences in the proportion of subjects with anti-pneumococcal antibody concentrations ≥0.2 μg/ml or anti-pneumococcal GMC were seen between the two groups after the fourth vaccine dose. A schedule of HibMenCY-TT given concomitantly with PCV7 and DTaP-HepB-IPV would be expected to protect infants against all of the targeted diseases.     

DTaP-IPV/Hib vaccine (Pentacel)

The combination vaccine diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccine (DTaP-IPV/Hib), which has been exclusively used in Canada for more than 10 years, is the first DTaP-based vaccine approved in the US that includes both poliovirus and Haemophilus influenzae type b (Hib) antigens. In clinical trials, the combined DTaP-IPV/Hib vaccine induced high immunogenecity against all of the vaccine antigens, including Hib. Administration of the DTaP-IPV/Hib vaccine as a four-dose series in infants provided high levels of seroprotection against diphtheria and tetanus toxoids, poliovirus types 1, 2, and 3, and Hib polyribosyl-ribitol-phosphate capsular polysaccharide conjugated to tetanus toxoid (PRP-T). Immune responses produced after doses 3 and 4 of DTaP-IPV/Hib vaccine were noninferior to those seen with separately administered DTaP, inactivated poliovirus, and Hib vaccines, apart from those against PRP-T in one study. Seroconversion rates for the five pertussis components in DTaP-IPV/Hib vaccine were noninferior to those seen in infants receiving the separately administered vaccines. A serology bridging study showed the noninferiority of four doses of DTaP-IPV/Hib vaccine to three doses of a DTaP vaccine in terms of seroconversion rates for filamentous hemagglutinin and fimbriae 2 and 3, but not pertactin. There were no clinically relevant changes in the immunogenicity of DTaP-IPV/Hib when coadministered with pneumococcal-7-valent-CRM197 vaccine or measles, mumps, and rubella vaccine and varicella zoster vaccine at 15 months. The tolerability profile of DTaP-IPV/Hib vaccine was generally similar to that of separately administered DTaP, IPV, and Hib vaccines.     

Evaluation of two carrier protein-angiotensin I conjugate vaccines to assess their future potential to control high blood pressure (hypertension) in man

AIMS: We aim to modulate the renin-angiotensin system (RAS) by active immunization against angiotensin I hormone (AI), potentially providing a novel conjugate vaccine treatment for hypertension in man. METHODS: Immunization studies in rat and human subjects compare the effectiveness of tetanus toxoid (TT) and keyhole limpet haemocyanin (KLH) vaccines for immunotherapy following conjugation with an AI peptide analogue (AI). Cardiovascular responses were assessed in immunized rats and human subjects (two-dose trial only), following increasing i.v. infusions of either AI or angiotensin II hormone (AII). RESULTS: The AI-TT and AI-KLH conjugate vaccines induced an equivalent immune response, and inhibition of the pressor effects to exogenous AI in rats. Single-dose clinical trials with both conjugate vaccines only resulted in an immune response to the KLH carrier protein. A two-dose clinical trial of AI-KLH conjugate vaccine resulted in a significant immune response to AI. A shift in diastolic blood pressure (DBP) dose-response was demonstrated following challenge with AI and AII for the study volunteer showing the largest anti-AI IgG induction. CONCLUSION: KLH was shown to be a suitable alternative to TT as a carrier protein for AI, thus supporting continued evaluation of our AI-KLH conjugate vaccine for treatment of hypertension in man.     

DTaP(5)-IPV-Hib vaccine (Pediacel®)

Pediacel? is a fully liquid formulation of a diphtheria, tetanus, five-component acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b combination vaccine, which does not require reconstitution. Both vial and prefilled syringe presentations of Pediacel? are available for use in the EU. In active-controlled clinical trials, primary and/or booster vaccination with Pediacel? was highly immunogenic, eliciting strong and sustained serologic responses against all its component toxoids/antigens when administered according to a variety of different schedules. In particular, pivotal studies showed that Pediacel? was generally similar and/or noninferior to reconstituted pentavalent and hexavalent diphtheria, tetanus, and acellular pertussis-based combination vaccines in terms of the seroprotection rates elicited against the diphtheria, tetanus, poliovirus, and Haemophilus influenzae type b components that these products have in common, as well as in terms of the seroresponse/booster response rates elicited against the acellular pertussis components that these products have in common. Differences in immune responses between Pediacel? and these vaccines were considered unlikely to be clinically significant. There was no clear evidence of clinically relevant changes in the immunogenicity of Pediacel? (or the coadministered vaccine) when given concomitantly with meningococcal group C conjugate, pneumococcal conjugate, or hepatitis B vaccines in clinical studies. Pediacel? was generally well tolerated and demonstrated low reactogenicity in clinical trials. It had an adverse event profile generally similar to that of other combination vaccines based on diphtheria, tetanus and acellular pertussis vaccine, including Infanrix?-IPV+Hib and Infanrix? hexa.     

Reduced-antigen combined diphtheria-tetanus-acellular pertussis vaccine (Boostrix)

The reduced-antigen combined diphtheria-tetanus-acellular pertussis vaccine (dTpa) is intended for use as a booster dose in individuals aged > or =4 years. A single dose of dTpa elicited generally similar levels of antibodies against pertussis antigens (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]) as a similar monovalent pertussis booster vaccine (ap) in adolescents or adults, irrespective of their prevaccination serological status or vaccination history. Levels of antibodies directed against diphtheria toxoid were similar in recipients of dTpa or a licensed reduced-antigen combined diphtheria-tetanus booster vaccine (Td). However, levels of antitetanus antibodies were significantly higher in recipients of Td vaccines compared with those receiving dTpa. Similar serological response rates were observed for anti-PT, -FHA and -PRN between those receiving dTpa or ap and a similar high percentage of recipients of dTpa and the Td vaccines had seroprotective levels of antibodies against diphtheria and tetanus toxoid. The most frequently reported local adverse reactions following immunisation with dTpa included pain, redness and swelling; general symptoms included fatigue, headache and fever.     

Private-sector vaccine purchase costs and insurer payments: a disincentive for using combination vaccines?

Combination vaccines have been endorsed as a means to decrease the number of injections needed to complete the childhood immunization schedule, yet anecdotal reports suggest that private providers lose money on combination vaccines. The objective of this study was to determine whether practices purchasing combination vaccines had significantly different vaccine costs and reimbursement compared to practices that were not purchasing combination vaccines. Using cross-sectional purchase and insurer payment data collected from a targeted sample of private practices in five US states, we calculated the average total vaccine cost and reimbursement across the childhood immunization schedule. The average vaccine purchase cost across the childhood schedule was significantly higher for practices using a combined vaccine with diphtheria, tetanus, acellular pertussis vaccine, inactivated polio vaccine, and Hepatitis B vaccine (DTaP-IPV-HepB) than for practices using either separate vaccine products or a combined vaccine with Haemophilus influenzae, type b vaccine and Hepatitis B vaccine (Hib-HepB). The average insurer payment for vaccine administration across the childhood schedule was significantly lower for practices using DTaP-IPV-HepB combination vaccine than for practices using separate vaccine products. This study appears to validate anecdotal reports that vaccine purchase costs and insurer payment for combination vaccines can have a negative financial impact for practices that purchase childhood vaccines.     

Safety and immunogenicity of two formulations of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae conjugate-hepatitis B vaccine in 15 to 18-month-old children

Combination vaccines decrease the number of injections and improve parental satisfaction and vaccination schedule compliance. In a phase 1, randomized, partially-blinded, single-dose booster study, we evaluated two formulations of an investigational liquid hexavalent vaccine containing diphtheria, tetanus, acellular pertussis (5-component), inactivated poliovirus, Haemophilus influenzae b conjugate and hepatitis B surface antigen (DTaP-IPV-Hib-HBV) in 60 healthy toddlers, 15 to 18 months of age, who had been primed with three doses of a licensed pentavalent diphtheria, tetanus, acellular pertussis (5-component), inactivated poliovirus, Haemophilus influenzae b conjugate (DTaP-IPV//PRP-T) vaccine. The DTaP-IPV//PRP-T vaccine was used as a control in 30 subjects. The investigational formulations, which contained the same DTaP-IPV components, differed only in Hib (content and conjugate) and HBV (content) (PRP-T/HBV10 = 12 mug Hib tetanus toxoid conjugate with 10 microg HBsAg; PRP-OMPC/HBV15 = 6 microg Hib Neisseria meningitidis outer membrane protein complex with 15 microg HBsAg). Injection-site pain, redness and swelling were reported by 46.7%, 46.7%, and 20.0% of the licensed vaccine recipients, 43.3%, 43.3%, and 26.7% of PRP-T/HBV10 recipients and 70.0%, 46.7%, and 46.7% of PRP-OMPC/HBV15 recipients, respectively. Fever > or = 37.8 degrees C and irritability were reported by 0% and 16.7% of licensed vaccine recipients, 10.3% and 23.3% of PRP-T/HBV10 recipients and 30.0% and 16.7% of PRP-OMPC/HBV15 recipients, respectively. There were no apparent differences between the groups in the proportion of participants achieving predefined, threshold or seroprotective immune responses. Geometric mean antibody levels for all antigens were similar except for anti-PRP levels, which were 19.0 microg/mL in recipients of the licensed vaccine, 40.8 microg/mL in PRP-T/HBV10 recipients and 9.4 microg/mL in PRP-OMPC/HBV15 recipients. We conclude that the hexavalent formulations appear generally well tolerated and immunogenic as a booster dose in these toddlers.     

Spotlight on Tdap₅ vaccine (Covaxis®) as a single-booster immunization for the prevention of tetanus, diphtheria, and pertussis: in children (aged ≥4 years), adolescents, and adults

Covaxis? (also licensed as Triaxis? or Adacel? in individual countries) is a Tdap? (i.e. combined tetanus toxoid, reduced diphtheria toxoid, five component acellular pertussis [namely detoxified pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3]) vaccine for the prevention of diphtheria, tetanus, and pertussis. It is approved for use in Europe as a single intramuscular booster dose in children (aged ≥4 years), adolescents, and adults, and in the US it is approved for use in individuals aged 11-64 years. In large, randomized, controlled clinical trials conducted in the UK and North America, a single intramuscular booster dose of Covaxis? induced robust immune responses for all of its component antigens when given to children (aged ≥4 years), adolescents, and adults. In addition, Covaxis? vaccine was safe and generally well tolerated in terms of solicited and unsolicited local injection-site and systemic adverse events, most of which were of mild intensity and resolved without sequelae. Furthermore, the immunogenicity of each individual component and the reactogenicity of Covaxis? vaccine in children, adolescents, and adults was generally similar to that of comparator vaccines. Despite being a vaccine-preventable disease and having >90% primary vaccination coverage worldwide, pertussis remains uncontrolled, particularly amongst adolescents and adults. Given the changing epidemiology of pertussis and the requirement to reduce infection in adolescents and adults (including healthcare workers) and thereby prevent transmission of the disease from these individuals to very young infants, the new 'cocoon strategy' recommended in current vaccination guidelines has become a key strategy in the management of morbidity and mortality associated with pertussis. This strategy focuses on the immunization of healthcare workers, and the parents and family members of infants who are too young to have undergone primary immunization, so as to prevent the transmission of pertussis to these young at-risk infants. The implementation of the 'cocoon strategy' may finally give countries the ability to control pertussis infections in these at-risk infants and ultimately provide the desired herd immunity against pertussis. In line with this strategy, a booster dose of Covaxis? vaccine provides a valuable option to reduce pertussis morbidity and mortality, and to maintain seroprotection against diphtheria and tetanus in children (aged ≥4 years), adolescents, and adults.     

Comparisons of immunization records between a community pharmacy,a regional registry,and a health system

Objectives

To compare the completeness of immunization records for 6 vaccines between a community pharmacy database, a regional immunization information system (IIS), and a health system’s electronic health record (EHR).

An experimental divalent vaccine based on biodegradable microspheres induces protective immunity against tetanus and diphtheria

In an endeavor towards development of multivalent vaccines based on biodegradable microspheres, we tested the immunologic performance of several divalent microsphere formulations against tetanus and diphtheria. Microspheres were made by separate microencapsulation of tetanus and diphtheria toxoid in poly(lactide-co-glycolide) by either spray-drying or coacervation. Guinea pigs were subcutaneously immunized by a single injection of the divalent vaccines or, for control, an equivalent dose of a licensed vaccine containing both antigens adsorbed on aluminium hydroxide. All microsphere formulations were strongly immunogenic, irrespective of particle size and hydrophobicity. End point titers of ELISA antibodies, mainly of the IgG1 subtype, were comparable to those obtained after immunization with the licensed vaccine. The microspheres provided increasing levels of antibodies, during the 16 weeks of testing, and the antibodies were weakly polarized towards tetanus. The induced antibodies were also toxin neutralizing, as determined for both diphtheria (1-4 IU/mL) and tetanus (5-9 IU/mL) 8 weeks after immunization. These neutralization levels were several orders of magnitude above the level considered minimum for protection (0.01 IU/mL). When the animals were challenged with tetanus or diphtheria toxins 6 weeks after immunization, microsphere vaccines produced protective immunity that was comparable to or better than that induced by the licensed divalent vaccine. In conclusion, this study showed that a single administration of biodegradable microsphere vaccines provided protective immunity against diphtheria and tetanus, and that this immunization approach might be feasible for multivalent vaccines.