中国婴幼儿接种吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗的安全性和免疫原性研究

目的 比较吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗(DTaP-IPV//PRP～T联合疫苗)与吸附无细胞百白破联合疫苗(DTaP)、b型流感嗜血杆菌结合疫苗(Hib结合疫苗)、注射用灭活脊髓灰质炎疫苗(IPV)的免疫原性和安全性.方法 受试者随机分为三组.试验组(A组和B组)分别于2、3、4月龄...     

Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea

This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim™) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately. Immunogenicity was high in both groups; seroprotection and seroconversion rates of the combined vaccine (Group A) were non-inferior to the control vaccines (Group B). All subjects were seroprotected against poliovirus types 1, 2 and 3 (≥8 1/dil) and anti-diphtheria (≥0.01 IU/mL); 99.0% were seroprotected against tetanus (≥0.1 IU/mL). At least 93.6% had anti-diphtheria antibody titers ≥0.1 IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (≥4-fold increase in antibody titer) rates were 96.6% and 94.4% for Group A, 92.2% and 78.4% for Group B. Most solicited reactions occurred within 4 days of vaccination, resolved within 3 days and were mild. Severe solicited reactions occurred after ≤0.5% of doses in Group A and ≤0.9% in Group B. No withdrawals occurred because of adverse events. The DTaP-IPV combined vaccine given at 2, 4, and 6 months of age was well tolerated; immunogenicity was similar to the control vaccines.     

以吸附无细胞百日咳-白喉-破伤风疫苗为基础的联合疫苗研究进展

吸附无细胞百日咳疫苗、白喉和破伤风类毒素联合疫苗（Adsorbed Acellular Pertussis Vaccine,Diphtheria Toxoid＆Tetanus Toxoid Combined Vaccine,DTaP）已有30多年的使用历史。将DTaP与乙型肝炎疫苗（Hepatitis B Vaccine,HepB）、脊髓灰质炎灭活疫苗（Inactivated Poliovirus Vaccine,IPV）和b型流行性感冒嗜血杆菌结合疫苗（Haemophilus Influenzae Type b Conjugate Vaccine,Hib）等制备成为联合疫苗使用,可以减少接种剂次,提高受种者的依从性,从而提高疫苗接种率。但是,联合疫苗不是几种疫苗简单地混合,在将DTaP与其他疫苗联合的过程中面临许多技术挑战,如DTaP与Hib联合存在Hib免疫原性降低的问题,DTaP与HepB联合存在免疫程序不统一和HepB免疫持久性的问题,DTaP与IPV联合时,其中的防腐剂柳硫汞会降低IPV的免疫原性的问题等。现就DTaP与这些疫苗联合时所面临的技术挑战、目前的研究进展和未来发展方向作一综述。     

Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine and guidance for use as a booster dose

On June 24, 2008, the Food and Drug Administration licensed a combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine, DTaP-IPV (Kinrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Kinrix is licensed for use as the fifth dose of the DTaP vaccine series and the fourth dose of the IPV series in children aged 4-6 years whose previous DTaP vaccine doses were DTaP (Infanrix, GlaxoSmithKline) and/or DTaP-Hepatitis B-IPV (Pediarix, GlaxoSmithKline) for the first 3 doses and DTaP (Infanrix) for the fourth dose. DTaP-IPV administered to children aged 4-6 years would reduce by one the number of injections needed to complete DTaP and IPV immunization. This report summarizes the indications for Kinrix and provides guidance from the Advisory Committee on Immunization Practices (ACIP) for its use.     

Vaccination coverage among children entering school--United States, 2005-06 school year

One of the national health objectives for 2010 is to achieve and sustain > or =95% vaccination coverage among children in kindergarten through first grade for the following vaccines: hepatitis B vaccine; diphtheria and tetanus toxoids and pertussis vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine, or diphtheria and tetanus toxoids vaccine (DTP/DTaP/DT); poliovirus (polio) vaccine; measles, mumps, and rubella vaccines; and varicella vaccine. To determine vaccination coverage among children entering kindergarten, data were analyzed from reports submitted to CDC by states and the District of Columbia (DC) for the 2005-06 school year. This report summarizes the results of that analysis, which indicated that coverage for each vaccine was reported to have exceeded 95% in more than half of the states.     

Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years

Combination vaccines represent one solution to the problem of increased numbers of injections during single clinic visits. A combined DTaP-IPV (Infanrix-IPV) vaccine has been developed for use as a pre-school booster. Four hundred healthy children aged 4-6 years previously primed with 4 doses of DTaP vaccine (Infanrix), 3 doses of poliovirus vaccine and 1 dose of MMR vaccine were randomized to receive single doses of either the combined DTaP-IPV vaccine or separate DTaP and IPV vaccines in a Phase II trial (DTaP-IPV-047). All children also received a second dose of MMR vaccine. Immunogenicity was assessed in serum samples taken before and 1 month after booster administration. Safety was actively assessed for 42 days post-vaccination. Non-inferiority of the DTaP-IPV vaccine to separate DTaP and IPV vaccines was demonstrated for all DTaP antigen booster response rates and poliovirus geometric mean titers of antibody ratios. Post-vaccination, > or =99.4% of children in both groups had seroprotective levels of anti-diphtheria and anti-tetanus antibodies (> or =0.1IU/mL) and seroprotective anti-poliovirus antibody titers (> or =1:8). All children in both groups were seropositive for measles, mumps and rubella antibodies, with similar post-vaccination geometric mean concentrations/titers. No significant differences were observed in the incidence of solicited local or general symptoms, unsolicited symptoms and serious adverse events between the two groups. This combined DTaP-IPV appeared safe and immunogenic when given as a booster dose at 4-6 years of age. The DTaP-IPV vaccine had no negative effect on the response to co-administered MMR vaccine, making it well-suited for use as a pre-school booster.     

Immunogenicity study of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine used to reconstitute a freeze-dried Haemophilus influenzae type b vaccine (DTaP-IPV//PRP-T) administered simultaneously with a hepatitis B vaccine at two, three and four months of life

This study was designed to assess the immunogenicity of a vaccine combining diphtheria and tetanus toxoids, acellular pertussis vaccine, and inactivated poliovirus vaccine reconstituting Haemophilus influenzae type b polysaccharide conjugated to tetanus protein (DTaP-IPV//PRP-T; Pasteur Mérieux Connaught, Lyon, France) administered simultaneously in association with hepatitis B vaccine (RECOMBIVAX (?trade mark omitted?) Merck, Sharp & Dohme, West Point, PA, USA) for the primary immunization of infants. The vaccines were administered at two, three and four months of age. One hundred and sixty-two healthy infants, aged 8-10 weeks, were enrolled in the study. Blood samples were taken before the first dose and 4 weeks after the third dose. The infants were observed for 15 minutes after vaccination for any immediate reaction. Adverse events requiring a medical consultation were recorded by the parents in a diary over the 7 days following vaccination. Four weeks after the third immunization, the percentages of infants fulfilling seroconversion criteria were 98.9% for pertussis toxin, 95.9% for filamentous haemagglutinin, 100.0% for tetanus, 100.0% for diphtheria, 99.3% for poliovirus type 1, 100.0% for both poliovirus types 2 and 3, 98.0% for Haemophilus influenzae type b, and 100% for hepatitis B surface antigen. No vaccine-related serious adverse event was reported. The simultaneous administration of DTaP-IPV//PRP-T and hepatitis B vaccines at two, three and four months of age yielded clinically satisfactory immune responses to all antigens compared with historical controls and gave a good safety profile.     

Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China

The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim^®) compared to individual vaccines in infants in the People's Republic of China. Infants (N = 792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib^®) and IPV (Imovax^® Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.     

The immunogenicity of oral poliomyelitis vaccine in a primary vaccination series at 2, 4 and 6 months given concurrently with Hib,hepatitis B and diphtheria,tetanus and whole-cell pertussis vaccines administered as three separate injections or as a combination pentavalent vaccine

The increasing number of infant immunisations has spurred development of novel combination vaccines. This investigation assesses the immunogenicity of oral poliomyelitis vaccine (OPV) under current and possible new conditions, to help ensure vaccination regimes continue to provide optimal protection against polio in the final stages of polio eradication. Neutralising antibody titres were measured in approximately 200 infants immunised with OPV at 2, 4 and 6 months in tandem with either a combined pentavalent liquid Haemophilus influenza B (Hib), hepatitis B, diphtheria, tetanus and whole-cell pertussis vaccine or three separate but concurrently administered licensed vaccines (diphtheria, tetanus and whole-cell pertussis (DTP), lyophilised Hib, and hepatitis B). Following three doses of OPV, at least 98% of infants demonstrated neutralising antibodies at 1:8 to each poliovirus type under both vaccination regimes, and geometric mean titres (GMTs) well above the suggested protective titre were also observed for all poliovirus types. OPV appears to be effective not only in producing protective antibody titres in an extremely high proportion of infants when given in combination with currently licensed vaccines, but also when administered together with the combination pentavalent vaccine under study. This is encouraging for the continued role of OPV in infant immunisation.     

Associated or combined vaccination of Brazilian infants with a conjugate Haemophilus influenzae type b (Hib) vaccine, a diphtheria-tetanus-whole-cell pertussis vaccine and IPV or OPV elicits protective levels of antibodies against Hib

This study investigated the immunogenicity and safety of including a Haemophilus influenzae type b vaccine (polyribosylribitol phosphate conjugated to tetanus toxoid, PRP-T) in three different vaccination schemes: (1) PRP-T reconstituted with a combined diphtheria-tetanus-pertussis-inactivated poliovirus vaccine (DTP-IPV//PRP-T); (2) PRP-T reconstituted with DTP and administered concomitantly with an oral poliovirus vaccine (DTP//PRP-T+OPV); and (3) PRP-T administered concomitantly with DTP at a different injection site and OPV (DTP+PRP-T+OPV). Vaccines were given at 2, 4, and 6 months of age. A total of 252 infants were enrolled, and randomly assigned to one of the three vaccination groups (84 infants in each group); 241 infants were followed until the end of the study. Antibody production against PRP, diphtheria, tetanus and pertussis antigens was satisfactory for each vaccination scheme used. A good response to Hib vaccine was elicited in each group, and 3 months after the third vaccine dose, at least 97% of children in each group had levels of PRP antibody considered to be seroprotective (>0.15 microg/ml), and over 90% of children in each group had levels over 1. 0 microg/ml. The solicited local and systemic adverse events following vaccination were mild in all groups and resolved within 4 days without medical intervention. With the exception of fever, which was more common after the second dose in children who received DTP-IPV//PRP-T, local and systemic reactions did not differ between the vaccination groups. Due to the practical advantages of combined vaccines, their use in routine immunization programs in developing countries is highly desirable. Our results show that Hib conjugate vaccine can be included in routine immunization programs that include either OPV or IPV with satisfactory immunogenicity and safety profiles. This flexible approach should facilitate the inclusion of the Hib conjugate vaccine in routine immunization programs on a world-wide scale.     

Immunization coverage among predominantly Hispanic children, aged 2-3 years, in central Los Angeles

PURPOSE: To assess the immunization status of young children in a predominantly Hispanic region in and around downtown Los Angeles, and factors associated with complete immunization by age 24 months. METHODS: The information was gathered in a two-stage cluster survey with probability proportionate to estimated size (PPS) sampling of 30 clusters at the first stage, and simple random sampling of a constant number of children at the second stage. Vaccination coverage was determined by a review of the home immunization (HI) card, or of clinic records. RESULTS: Of the 270 sampled children, 91.5% were Hispanic and 6.7% were Black. Home telephone numbers were not available in 24.8% of the homes, and 34.1% reported having no health insurance. Vaccination coverage was over 90% for the first three doses of Diphtheria, tetanus toxoids and pertussis/ diphtheria, tetanus toxoids and acellular pertussis vaccine (DTP/DTaP)/Diphtheria and tetanus toxoids vaccine (DT), first two doses of poliovirus (Polio) vaccine, first dose of measles, mumps and rubella (MMR) vaccine, and first two doses of hepatitis B (Hep B) vaccine. Yet, by age 24 months, only 72.2% of the children had received the combined series of 4:3:1 (i.e., four DTP/DTaP/DT, three Polio, one MMR). This was further reduced to 64.4% for the combined series of 4:3:1:3:3 (i.e., four DTP/DTaP/ DT, three Polio, one MMR, three Haemophilus influenzae type b (Hib), three Hep B). Factors associated with completed on-time vaccination were having an HI card available during the interview and being enrolled in Supplemental Nutrition Program for Women, Infants and Children (WIC). CONCLUSIONS: While vaccination levels for individual antigens were found to be high, more emphasis needs to be placed on getting preschool children vaccinated on-time according to the Recommended Childhood Immunization Schedule.     

Impact of multiple injections on immunization rates among vulnerable children

BACKGROUND: In 1997, the Advisory Committee on Immunization Practices (ACIP) recommended a switch from oral polio vaccine (OPV) to inactivated polio vaccine (IPV) for the first two infant doses. The ACIP also recommended use of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) for infants. These recommendations resulted in two additional injections at the 2- and 4-month immunization visits. This study evaluates the implementation of new IPV and DTaP immunization recommendations and their impact on immunization coverage levels. METHODS: Immunization coverage was assessed in public clinics in three urban areas before and after the recommendations. One pre- and three post-recommendation cohorts were followed to 12 months of age. RESULTS: Almost all (> or = 88%) infants in the pre-recommendation cohort received OPV, DTP, and only one or two injections. Almost all (> or = 78%) infants in the post-recommendation cohorts received IPV, DTaP, and three or four injections. The percentage of infants in the post-recommendation cohorts up-to-date for immunizations at 12 months of age was slightly higher than those in the pre-recommendation cohort. CONCLUSIONS: Providers rapidly switched from OPV and DTP to IPV and DTaP. Coverage at 12 months of age was higher among IPV/DTaP recipients than among OPV/DTP recipients. Provider and parent acceptance of four injections at a visit was high. The recent pneumococcal conjugate vaccine recommendations potentially add a fifth injection at 2 and 4 months of age. Acceptance or rejection of five injections by providers and parents needs early assessment.     

An open-label, randomized, multi-center study of the immunogenicity and safety of DTaP-IPV (Kinrix™) co-administered with MMR vaccine with or without varicella vaccine in healthy pre-school age children

Background

In the US, it is recommended that 4-6 year old children receive diphtheria-tetanus-acellular pertussis (DTaP), inactivated poliovirus (IPV), measles-mumps-rubella (MMR), varicella (V), and influenza vaccines. Data relating to the concomitant administration of combination DTaP-IPV vaccine (Kinrix™; GlaxoSmithKline Biologicals) and influenza or V vaccines are currently limited. This study was undertaken to evaluate the immunogenicity and reactogenicity of Kinrix™ when co-administered with MMR (M-M-RII^®, Merck & Co.) and Varivax™ (Merck & Co.) in 4-6 year old children.

Methods

Phase IIIb, open-label, non-inferiority study (NCT00871117). We randomized (1:1) healthy 4-6 year olds to receive Kinrix™ + MMR + V on day 0 (Group 1), or Kinrix™ + MMR on day 0, followed by V at month 1 (Group 2). We measured DTaP-IPV immunogenicity before and 1 month post-vaccination (prior to V vaccination in Group 2). We collected local and general solicited symptoms within 4 days after vaccination and serious adverse events (SAEs) through 6 months post-vaccination.

Results

We enrolled 478 subjects. One month post-vaccination, >95% of subjects in both groups had booster responses to diphtheria, tetanus and pertussis antigens and all subjects had seroprotective anti-poliovirus antibody titers. Immune responses in Group 1 were non-inferior to Group 2 for responses to DTaP-IPV antigens according to pre-specified criteria. Reporting of solicited local events at the DTaP-IPV site appeared to be similar between the two vaccine groups, as was reporting of solicited general adverse events within 4 days of vaccination; no vaccine related SAEs were reported.

Conclusion

Concomitant administration of varicella vaccine with Kinrix™ and MMR did not impact the immunogenicity of diphtheria, tetanus, pertussis or poliovirus antigens. Both vaccine regimens were well tolerated. These results support the co-administration of DTaP-IPV, MMR, and V vaccines in 4-6-year-old children, providing protection against multiple diseases in a timely and efficient manner.     

An adolescent-adult formulation tetanus and diptheria toxoids adsorbed combined with acellular pertussis vaccine has comparable immunogenicity but less reactogenicity in children 4-6 years of age than a pediatric formulation acellular pertussis vaccine and diphtheria and tetanus toxoids adsorbed combined with inactivated poliomyelitis vaccine

In Canada, the fifth dose of the routine childhood immunization schedule against diphtheria, tetanus, pertussis and polio is given at 4-6 years of age. Up to 30% of children may have significant local reactions (redness, swelling) and this may be related to pertussis and diphtheria antigen content. We sought to determine if a combination product with lower content of pertussis and diphtheria toxoids (dTap) would result in fewer local reactions and not have inferior immunogenicity to a combination vaccine with higher pertussis and diphtheria content (diphtheria-tetanus-acellular pertussis-inactivated polio virus, DTaP-IPV). Healthy children aged 4-6 years with complete primary immunization series and a fourth dose of diphtheria and tetanus toxoids component pertussis inactivated polio and Haemophilus influenzae type B conjugate vaccine were randomized to one dose of dTap, followed in 4-6 weeks by one dose of IPV or control DTaP-IPV. Immediate reactions within 30 min, solicited injection site and systemic reactions within 14 days, and unsolicited adverse events (AE) within 6 weeks post-vaccination were monitored. Serum was collected prior to immunization, and 4-6 weeks after vaccine for diphtheria, tetanus and pertussis antibodies (Ab). Sample size was designed to detect > or =10% difference in injection site erythema, pain or swelling between groups 593 children at eight Canadian sites completed the study; no participant withdrew because of an AE. All safety endpoints on days 0-14 were less frequent in children randomized to the dTap than DTaP-IPV group: erythema (34.6% versus 51.7%), swelling (24.2% versus 33.8%) and pain (39.6% versus 67.2%). Fever was also less common (8.72% versus 16.9%). All children in both study groups had seroprotective Ab levels to diphtheria and tetanus at 4-6 weeks (> or =0.10 IU/mL). The majority of children in each vaccine arm had a four-fold increase in pertussis antibodies. Fever and injection site reactions are less common in 4-6 year-old-children who receive a dTap vaccine compared to DTaP-IPV, without inferior immunogenicity.     

Vaccination coverage among children in kindergarten--United States, 2006-07 school year

Healthy People 2010 objectives include increasing vaccination coverage among children in kindergarten and first grade (objective 14-23). For these children, the target is >/=95% vaccination coverage for the following: hepatitis B vaccine; diphtheria and tetanus toxoids and pertussis vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine, or diphtheria and tetanus toxoids vaccine (DTP/DTaP/DT); poliovirus vaccine; measles, mumps, and rubella (MMR) vaccine; and varicella vaccine. To assess progress toward national goals and determine vaccination coverage among children in kindergarten, data were analyzed from reports submitted to CDC by 49 states and the District of Columbia (DC) for the 2006-07 school year. This report summarizes findings from that analysis, which indicated that approximately 75% of states have reached the 2010 objective of at least 95% coverage for all of the vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) for children in kindergarten. These results underscore the effectiveness of school-entry requirements in increasing vaccination coverage but highlight a need for more standardized vaccination reporting among states.     

Antibody persistence at 18-20 months of age and safety and immunogenicity of a booster dose of a combined DTaP-IPV//PRP∼T vaccine compared to separate vaccines (DTaP, PRP∼T and IPV) following primary vaccination of healthy infants in the People's Republic of China

This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP-IPV//PRP∼T (Pentaxim^®, Sanofi Pasteur's AcXim family) combined vaccine and of standalone vaccines one year after primary vaccination in the People's Republic of China. Participants (N = 719) previously primed with DTaP-IPV//PRP∼T at 2, 3, 4 months (Group A, N = 255), 3, 4, 5 months (Group B, N = 233), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib^®) and IPV (Imovax^® Polio) at 3, 4, 5 months (Group C, N = 231) received boosters of the same vaccines at 18-20 months of age. Seroprotection (SP) and seroconversion (SC) were determined before and 1 month after the booster. Safety was monitored from parental reports. In all groups 87.6-100% of participants had pre-booster protective anti-PRP, -diphtheria, -tetanus and -poliovirus antibody titers; post-booster, all SP rates were 100% and SC was ≥80.4% for anti-pertussis titers ≥ 4-fold increase. Reactogenicity was low for each group. These data support the use of the DTaP-IPV//PRP∼T vaccine in the People's Republic of China compared to separate DTaP, IPV, and PRP∼T administration in terms of both safety and immunogenicity.     

Effect of injection site on reactogenicity and immunogenicity of acellular and whole-cell pertussis component diphtheria-tetanus-pertussis vaccines in infants

The effect of injection site on reactogenicity and specific immunogenicity was assessed in participants in a pertussis vaccine efficacy trial. The percent of DTwP and DTaP recipients with any reaction was slightly lower in subjects injected in the buttock compared with those injected in the thigh. This finding was most common in DTwP recipients. Geometric mean antibody values to pertactin, filamentous hemagglutinin and fimbriae (Bordetella pertussis antigens) were lower in DTaP vaccinees when buttock was utilized as the injection site. Our findings present evidence against the use of the buttock as the site of immunization for DTaP vaccines since the benefit with regards to reactogenicity is minimal and the immunologic response to an important antigen of B. pertussis, pertactin, is decreased.     

两种百白破联合疫苗接种后安全性比较

为了比较全细胞百白破联合疫苗 (DTwP)与无细胞百白破联合疫苗 (DTaP)在婴幼儿群体中接种后的安全性 ,对 3～ 6个月的婴儿及 18～ 2 4个月的幼儿进行了两种疫苗接种后安全性的临床观察。结果显示 :基础免疫接种DTwP后全身反应发生率为 18 0 9% ,局部反应发生率为 18 4 8% ;接种DTaP后全身、局部反应发生率均为1 97%。加强免疫接种DTwP后全身反应发生率为 34 87% ,局部反应发生率为 2 9 89% ;接种DPaT后全身反应发生率为 4 93% ,局部反应发生率为 5 80 %。表明DTaP有更好的安全性     

Can monovalent hepatitis A and B vaccines be replaced by a combined hepatitis A/B vaccine during the primary immunization course?

A combined hepatitis A/B vaccine (Twinrix Adult) has been licensed in Germany since 1997. We investigated possible differences in immunogenicity and safety when changing over from vaccinations with monovalent vaccines made by different manufacturers to vaccinations with the combined hepatitis A/B vaccine in an open, randomized, multicenter trial. We therefore compared four different schemes changing over from concomitant vaccinations with monovalent vaccines against hepatitis A and B (Havrix 1440+Engerix-B or Vaqta+Gen H-B-Vax) to combined vaccination against hepatitis A+B with three injections of the combined hepatitis A/B vaccine (0, 1, and 6 month schedule). Local and general symptoms were mostly mild in all five groups. With complete three-dose course using the combined vaccine or an early changeover from monovalent vaccines to the combined vaccine, higher overall anti-HBs seroprotection rates and geometric mean concentrations (GMCs) against hepatitis B could be achieved as early as after 2 months as compared to those groups switching later to the combined vaccine. This study demonstrated for the first time that switching from monovalent hepatitis A and B vaccinations to the combined hepatitis A and B vaccination has no negative influence on the tolerability and improves the immunogenicity.     

Dynamic profiles of neutralizing antibody responses elicited in rhesus monkeys immunized with a combined tetravalent DTaP-Sabin IPV candidate vaccine

The World Health Organization has recommended that a Sabin inactivated polio vaccine (IPV) should gradually and synchronously replace oral polio vaccines for routine immunizations because its benefits in eliminating vaccine-associated paralytic poliomyelitis have been reported in different phases of clinical trials. It is also considered important to explore new tetravalent diphtheria, tetanus, and acellular pertussis-Sabin IPV (DTaP-sIPV) candidate vaccines for possible use in developing countries. In this study, the immunogenicity of a combined tetravalent DTaP-sIPV candidate vaccine was investigated in primates by evaluating the neutralizing antibody responses it induced. The dynamic profiles of the antibody responses to each of the separate antigenic components and serotypes of Sabin IPV were determined and their corresponding geometric mean titers were similar to those generated by the tetravalent diphtheria, tetanus, and acellular pertussis-conventional IPV (DTaP–cIPV), the tetravalent diphtheria, tetanus, and acellular pertussis (DTaP), and Sabin IPV vaccines in the control groups. This implies that protective immunogenic effects are conferred by this combined tetravalent formulation.