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@#Combined vaccine is a single vaccine preparation made by mixing two or more different organism or purified antigens by physical methods.The use of combined vaccine can reduce the number of immunization shots and improve the compliance of children and acceptance of parents;reduce the costs of transportation,storage and management;avoid missing vaccination and improve vaccination rate.At present,a variety of combined vaccines have been licensed abroad,which have good safety and immunogenicity;some combined vaccines have been put on the market in China,and many combined vaccines are in clinical trials.In recent years,with the successful development of component pertussis vaccine and inactivated poliovirus vaccines of Sabin strain Ⅰ,Ⅱ and Ⅲ in China,the combined vaccines based on diphtheria-tetanus-acellular pertussis vaccine(DTaP) have been greatly developed.In this paper,the research progress on combined vaccines based on DTaP,which have been licensed and in clinical trials at home and abroad,was reviewed,in order to provide ideas for the development of related combined vaccines in China.
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Combined immunization consists of combined vaccines (including polyvalent vaccines) and simultaneous administration of vaccines, aiming to reduce unnecessary inoculating times for children, and to broaden immunization coverage and a significant larger group of population would be benefit from the Expanded Program on Immunization. In this review, we have summarized a list of research papers focused on combined immunization. By scrutinizing the safety and effectiveness outcomes of combined immunization, we provide some suggestions about upgrading the current immunization program as well as research and development of new combined vaccines.
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Combined immunization consists of combined vaccines (including polyvalent vaccines) and simultaneous administration of vaccines, aiming to reduce unnecessary inoculating times for children, and to broaden immunization coverage and a significant larger group of population would be benefit from the Expanded Program on Immunization. In this review, we have summarized a list of research papers focused on combined immunization. By scrutinizing the safety and effectiveness outcomes of combined immunization, we provide some suggestions about upgrading the current immunization program as well as research and development of new combined vaccines.
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Objective To observe the concentration of the anti-HBs of children boosted with hepatitis A and B combined vaccine for 3 dosages, and to provide the basis for the implementation of hepatitis B booster immunization. Methods In September 2009 in Yuhuan by employing the cluster sampling method, 123 children, ranging from 6 to 9 years old, who had completed the basic immunization by 0-1-6 procedure without hepatitis B vaccine boosted and without anti-HBs were selected. In the year of 2011 (after 1 year of inoculation) and 2015 (5 years after inoculation), the venous blood samples were collected to determine the concentration of anti-HBs. Results Boosted with hepatitis A and B combined vaccine for 3 times, the anti-HBs of 102 subjects was tested in the next year, of which the anti-HBs of 82 subjects was detected again in the later 5 years. The results suggested that the positive rates of antibody enhanced were 92.16% after 1 year and 78.05% after 5 years, respectively. The average concentration of anti-HBs of these 82 subjects was 2.95 mIU/mL before inoculation, 141.76 mIU/mL one year later and 72.13 mIU/mL 5 years later and there was statistically significant difference among them (P <0.05) . The difference was not statistically significant between subjects with different years of birth (P>0.05) . Moreover, the interaction was existed between the year of blood detection and year of birth (P <0.05) . Conclusion To children aged 6-9 years old whose anti-HBs were negative after the primary immunization of hepatitis B, booster immunization with 3 dosages of hepatitis A and B combined vaccine shows good immune effect against hepatitis B virus.
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Objective To evaluate the effectiveness and safety of DTaP-IPV/Hib combined vaccine in comparison with commercially available DTaP (diphtheria, tetanus and pertussis), Haemophilus influenzae type b (Hib), tetanus conjugate and IPV monovalent vaccine. Methods Randomized controlled trials (RCTs) on DTaP-IPV/Hib were retrieved by searching interna-tional and national databases. The pooled mean difference and relative risk and 95% CI were assessed by meta analysis with RevMan 5.0 software. Results Totally 6 studies were included for the final analysis. The seroprotection/seroconversion level of the Anti-PT (RR=0.26, 95%CI: 0.14, 0.48) in combination vaccine was higher. The antibody titer levels of Anti-PT (WMD=21.11, 95%CI:9.36, 32.86), Anti-polio type1 (WMD=59.15, 95%CI:2.81, 115.48), Anti-polio type 3 (WMD=169.82, 95%CI:75.33, 264.30) were higher respectively. But the antibody titer level of Anti-PRP (WMD=-3.58, 95%CI:-5.52,-1.64) in the com-bination vaccine group was lower. Redness (RR=0.82, 95%CI:0.72, 0.93) and Tenderness (RR=0.45, 95%CI:0.30, 0.65) were lower in the combination vaccine. Swelling (RR=2.03, 95%CI:1.02, 4.01) was more common in the patients given the combina-tion vaccine. Conclusions This study supports the conclusion that the DTaP-IPV/Hib combination vaccine is equivalent to the separate injections based on similar antibody responses to the vaccine antigens, effectiveness and safety after primary doses.
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Objective To evaluate the immune effects of bivalent inactivated rotavirus vaccine (IRV) and investigate the viability of development of bivalent IRV.Methods Firstly,bivalent IRV was prepared by mixing G1 IRV and G3 IRV with equal amount,G1 IRV and G3 IRV as monovalent control,PBS as negative control.Secondly,those vaccines were vaccinated to the mice by intramuscular injection.Then,to evaluate the immune effects of bivalent IRV,the levels of serum or fecal rotavirus specific IgG and IgA were assessed by ELISA,the levels of serum neutralized antibody were measured by microneutralization assay,the number of IFN-γ or IL-4 secreting cells were analyzed by ELISPOT assay.Results Compared to negative control group,bivalent IRV induced the higher levels of serum and fecal G1 and G3 rotavirus specific antibody.It was found that there were no significant differences for the levels of serum IgG and IgA,fecal IgG and IgA,serum neutralized antibody between induced by bivalent IRV and induced by G1 type monovalent vaccines ; but there were significantly increase for the levels of serum IgG (t =2.691,P＜0.05) and serum neutralized antibody (t =2.561,P＜0.05) between induced by bivalent IRV and induced by G3 monovalent vaccines,there were no significant differences for other antibodies between induced by bivalent IRV and induced by G3 monovalent vaccines.At the same time,compared to negative control group,bivalent IRV induced significantly increase in the number of IFN-γ or IL-4 secreting cells in spleen lymphocytes.It was found that there were no significant differences for the number of IFN-γ or IL-4 secreting cells stimulated by G1 rotavirus between bivalent IRV and G1 monovalent vaccines; but there were significantly increase for the number of IL-4 secreting cells (t =2.327,P＜0.05) stimulated by G3 rotavirus between bivalent IRV and G3 monovalent vaccines,there were no significant differences for the number of IFN-γ secreting cells stimulated by G3 rotavirus between bivalent IRV and G3 type monovalent vaccines.Conclusion The bivalent IRV can induce effective immune response,in which there were no inhibitory interference between the components of bivalent IRV,which provided the experimental basis for the development of bivalent IRV.
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Objective The aim of this study was to demonstrate the immunogenicity and safety of diphtheria, tetanus, pertussis (acellular, component) , poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV//PRP-T) combined vaccine compared with commercially available DTaP (diphtheria, tetanus and pertussis), Haemophilus influenzae type b (Hib), tetanus conjugate and IPV monovalent vaccine. Methods Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIMTM) vaccinated at 2,3,4 months of age or 3,4, 5 months of age respectively; Group C was commercially available DTaP. Hib tetanus conjugate (Act-HIBTM) and IPV (IMOVAX PolioTM) vaccines vaccinated at 3,4, 5 months of age. All groups received booster dose at 18 to 20 months of age, with antibody titers tested. Non-inferiority analysis was demonstrated in terms of seroprotection / seroconversion rates between Group A, Group B respectively and Group C. Safety information was collected after each vaccination to assess the safety of investigational vaccines. Results The non-inferiority of DTaP-IPV//PRP-T combined vaccine vaccinated at 2,3,4 or 3,4, 5 months of age versus DTaP, Hib tetanus conjugate and IPV vaccine was demonstrated for all vaccine antigens in both primary and booster phases in terms of seroprotection/seroconversion rates. DTaP-IPV//PRP-T combined vaccine was well tolerated. The rate of solicited/unsoliciated severe adverse reactions was very low and similar to the control vaccines. Conclusion DTaP-IPV//PRP-T combined vaccine was highly immunogenic with good safety profile in Chinese infants, which was comparable to the commercially available control vaccines.
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Objective To research CpG and Al(OH)3 adjuvants enhancing immunogenicity of hepatitis C virus(HCV) recombinant ptotein combined vaccine(TIE).Methods BALB/c mice were immunized with candidate vaccine TFE using CpG,Al(OH)3,Al(OH) 3 + CpG,or freund's adjuvant(FA) as the adjuvant.Five mice were sacrificed after 10 d of the last immunization.Specific antibodies in sera were tested by enzyme-linked immunosorbent assay(ELISA).Splenic cells were isolated and levels of IFN-γ,IL-4 and cytotoxic T lymphocyte(CTL) cytotoxicity assay were messuredin vitro.The remaining mice were subcutaneouly injected with 1 × 106 SP2/0-NS3 cells on the back to investigate the protective effects.The differences of means between groups were compared by LSD-t test.Results The specific CTL activity of TFE + A1(OH) 3 + CpG group was higher than TFE + FA group and TFE + CpG group(P ＜ 0.05).The level of IFN-γsecreting cells in TFE + Al(OH)3 + CpG group was higher than that in TFE + M(OH)3 group or TFE + CpG group(P ＜ 0.05).Conclusion Combining Al(OH) 3 and CpG could enhance specific cellular immunogenicity of candidate HCV vaccine TFE.TFE + M(OH) 3 + CpG could effetively prevent the attack of tumor cell SP2/0-NS3 expressing nonstructural protein NS3 of HCV.
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Objective: To obtain immunogenicity and safety data for a pentavalent combination vaccine (diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Hib polysaccharide-conjugate). Design: Multicenter, open, Phase III clinical study. A DTaP-IPV//PRP~T vaccine (PentaximTM) was given at 6,10,14 weeks of age; and Hepatitis B vaccine at 0,6,14 or at 6,10,14 weeks of age. Immunogenicity assessed 1 month post-3rd dose; safety assessed for 30 minutes by the investigator, then by parents and investigators to 8 days and 30 days post-vaccination. Setting: Tertiary-care hospitals. Participants/patients: 226 healthy Indian infants (6 weeks of age). Main outcome measures: Immunogenicity and safety. Results: Immunogenicity was high for each vaccine antigen, and similar to a historical control study (France) following a 2,3,4 month of age administration schedule. Post-3rd dose, 98.6% of subjects had anti-PRP ³0.15 mg/mL and 90.0% had titers ³1.0 mg/mL; the anti-PRP GMT was 4.1 µg/mL. Seroprotection rates for diphtheria and tetanus (³0.01 IU/mL) were 99.1% and 100%; and 100%,99.1% and 100%, for polio types 1,2 and 3 (³8 [1/dil]) respectively. Anti-polio GMTs were 440.5,458.9, and 1510.7 (1/dil) for types 1,2 and 3 respectively. The vaccine response rates to pertussis antigens (4-fold increase in antibody concentration) were 93.7% for PT and 85.7% for FHA; the 2-fold increase was 97.1% and 92.4%. Vaccine reactogenicity was low with adverse reaction incidence not increasing with subsequent doses. Conclusion: The DTaP-IPV//PRP~T vaccine, given concomitantly with monovalent hepatitis B vaccine, was highly immunogenic at 6, 10 and 14 weeks of age in infants in India. The vaccine was well tolerated.
Subject(s)
Antibodies, Bacterial/blood , Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Female , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Haemophilus influenzae type b/immunology , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , India , Infant , Male , Poliovirus Vaccine, Inactivated/administration & dosage , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology , Prospective Studies , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology , Vaccines, Conjugate/administration & dosage , Vaccines, Conjugate/adverse effects , Vaccines, Conjugate/immunologyABSTRACT
Objective:To compare immune effects of hepatitis B-BCG combined vaccine and hepatitis B vaccine.Methods:The vaccines were administered to the guinea pig at 0, 1, 2 months. The tests were divided into three parts. The immune effects were compared in three kinds of the combined vaccine and hepatitis B vaccine(Part One), in three lots of the combined vaccine and hepatitis B vaccine(Part Two), in the group of combined vaccine and the group of hepatitis B vaccine and BCG(Part Three). After 1 month of each vaccine dose, serum specimens were measured for anti-HBs by ELISA.Results:The several studies have documented the serum anti-HBs concentritious in the group of combined vaccine in first dose were lower than those of the group of control, and the data showed no significantly difference. However, anti-HBs levels of the combined vaccine group in second vaccine dose and third vaccine dose were higher than those of the control group, and this difference was no longer statistically significant in group of combined vaccine and control, and among groups of combined vaccine.Conclusion:The immune efficacy of HBsAg in group of combined vaccine is similar to the group of hepatitis B vaccine in three doses immunization schedules.