中国疫苗和免疫最新文献

Objective: To evaluate the Immunogenicity of Group A and Group C Meningococcal conjugate Vaccine with coupling Group B Meningococcal Outer Membrane Protein (Men B-OMP).

Methods: 458 healthy children aged 3-5 months, 6-23 months, 2-6 years and 7-24 years were given the Groups A and C conjugate Vaccine with MenB-OMP or other vaccine as control group to measure the pre-and post-vaccination Men A and C and B by Serum Bactericidal Assay (SBA) in the double-blind randomized controlled trial.

Results: 97.65%-100% were 4 times or greater increase in SBA titer for the healthy children given the Groups A and C conjugate Vaccine with MenB-OMP, The geometric mean titer of SBA were 1:194-1:420, which significantly higber than controls.

Conclusion: The Group A and C conjugate Vaccine with MenB-OMP was safe and well immunogenic.

Objective: To Know the antibody level of comparison in maternal-infant pairs and the change of rubella in infants, and to provide scientific basis for controlling congenital rubella syndrome.

Methods: Newborn, 3, 6, 8, 9-month infant who never had rubella and their mothers were residents in Ningbo of Zhejiang, Harbin of Heilongjiang and Jinan of Shandong were collected as objects. Their serum samples were tested by the method of ELISA.

Results: The positive rate of Rubella antibody in newborns, 3, 6, 8, 9, were 74.4, 14.9, 3.3, 4.6, 15.0 percent respectively, and GMC were 34.06, 5.42, 1.48, 1.10, 1.83IU/ml respectively. The positive rate and GMC of Rubella antibody in mothers were 71.1 percent and 30.96IU/ml. The correlation coefficient between mother and infant was 0.658.

Conclusion: Maternal-transferred rubella antibody decreased as the growth of infants. The positive rate of measles antibody was very low in 6 and 8-month, which almost had no protection.

Objective: To review the safety of the inactivated split influenza vaccine, Anflu in a large scale population.

Methods: Selecting 14 districts national wide to inject the inactivated split influenza vaccines according schedules among infants, children, youths, adults and elder respectively. All volunteers were observed for AEFI after 7 days vaccinated.

Results: A total of 2794 volunteers aged 6 months to 90 years were enrolled in trials. The overall rate of adverse events was 6.6%.most adverse was mild reaction. Severe, infrequent or new adverse events were not reported. The rate of local reactions was 2.1%. The rate of local pain was 1.7%. The rate of systematic adverse events was 5.0%, fever took up 3.8%.

Conclusion: The inactivated split influenza vaccine, Anflu was safe.

Objective: To evaluate the safety and immunogenicity of Rabipur produced in India.

Methods: A random and single-blind study was conducted to compare the safety, effect and sero conversion rates. Rabipur produced in Germany used as control group.

Results: The results showed that they were no severe systemic and local reaction occurred in trial group (Rabipur produced in India). The difference between trial group and control group was not significant. 14 day and 45 days after the first dose, the seroconversion rates of the two groups were 100%. 14 day and 45 days after the first dose, GMC of the two groups increased obviously and highly beyond 0.5TU/ml.

Conclusion: Rabipur produced in India has excellent safety and immunogenicity. Trial Registration National Food Drugs Surveillance Administrative Bureau, "Medicine Clinical Experiment Written directive from a superior" 2005L04184.

Objective: To test the serum antibodies from healthy population by Serum Bactericidal Assay (SBA), in order to evaluate the level of protective antibodies against serogroup C Neisseria meningitidis in Liaoning province.

Methods: 240 serum samples were selected from eight age-group randomly. Serogroup C vaccine candidate strain (C11) and the prevail serogroup C strain (053442) were used for SBA.

Results: 48.33% of 240 serum samples were positive (titer > or = 1:2) to C11 vaccine strain. Protective rate of SBA was 35.83% (titer > or = 1:8), in which, > or = 6 years old were 13.33%, 7-19 years old was 61.67%, 20-39 years old were 46.67% and > or = 40 years old were 63.33%. Rate of SBA to 053442 was lower than that to C11 in the group over 15 years old by statistic analysis.

Conclusion: Population under 6 years old showed lower SBA capacities. With the implemention of Expanded Program on Immunization, children under 3 years old should be considered how to give them meningococcal vaccine in order to improve the titer of antibodies against Neisseria meningitidis serogroup C.

Objective: To evaluate the safety and immunogenicity of a new measles vaccine prepared by master seed lot original vaccine of Shanghai-191 strain.

Methods: According to selection and exclusion criteria, 8-10-month healthy children, who have no history of measles, measles vaccine inoculation and vaccination contraindication were selected. The children selected were vaccinated 0.5 ml measles attenuate live vaccine prepared by master seed lot vaccine of the Shanghai-191 strain. They were observed the local and systemic response in 30 min and 6h, 24h, 48h, 72h, 7d, 14d, 21d, 28d after inoculation, and immune serum were collected before immunization and after 28 days. Measles virus antibody positive rate and geometric mean titer (GMT) were detected by hemagglutination inhibition.

Results: There were not serious adverse reactions. Measles virus antibodies in serum positive rate was 100% after 28 days of immunization, and measles virus antibody GMT was 1:50.66.

Conclusion: New measles vaccine prepared by master seed lot original vaccine of the Shanghai-191 strain at 8-10-month children was safe and immunogenicity.

Objective: To evaluate the effect of measles control at different stages in Binzhou of Shandong.

Methods: The data of measles incidence, measles vaccine (MV) coverage, the population immune levels of measles IgG antibody from 1956 to 2008, and the cost-benefit of measles control were analyzed.

Results: The measles incidences were declined continually with implementing the strategies of measles control. Measles vaccine coverages have been keeping at the level of 87.12%-93.45% and the population immune levels of measles IgG antibody have been remaining at high level after implemention EPI. According to the progress of MV immunization strategy, the process of measles control could be divided into stage A (1956-1966, no specific immunization conducted), stage B (1967-1978, MV began to popularized), stage C (1979-1997, the EPI was implemented) and stage D (1998-2008, accelerated measles control and elimination). To compared between stage B and stage A, stage C and stage B, stage D and stage C, the average annual cases were decreased 9989, 18 500, and 378 respectirely, and the average annual dead cases were reduced 267, 49 and 50 respectively. The cost-benefit ratio was 1:22.97 for total 41 years on the process of the measles control and elimination from 1967 to 2008.

Conclusion: The effect was obtained on the process of measles control in Binzhou city. More efforts should be made to reach the target of measles elimination.

Objective: To establish HBV marker panels.

Methods: 155 blood plasma specimens were selected and each was detected twice for 5 HBV markers with MEIA kits made by Abbott. Any plasma that had 2 positive or negative results were enrolled in the HBV marker panels and others were excluded.

Results: 153 plasma were enrolled in the HBsAg panel and 154 were enrolled in anti-HBs, anti-HBc and anti-HBe panels respectively. Panel of HBeAg was not established because that there were only 4 positives.

Conclusion: HBV marker panels can be established by screening enough blood plasma specimens with high accurate kits for more than one time. The panels should be used in a limited extension to avoid unnecessary mistakes.

Objective: To Screen an EIA kit that fits best for using in serological detection of anti-HBc in the national investigation of hepatitis B virus infection.

Methods: Top 5 kinds of kits on the best seller list of China-made anti-HBc EIA kit were selected and each detect the anti-HBc panel (95 positive and 57 negative) 5 times. The co/s ratio of each test was recorded and transformed by Ig(co/s+1). Reliability indices ICC and CV, and validity indices AUC, pAUC and Se(FPR=e) were calculated and compared between each kit.

Results: The indices of ICC and CV of the 5 kinds of kits arranged in the same order of A, B, D, C and E, from the best to the worst. And the differences between them were significantly important (Bootstrap method, P < 0.05), except for between kits B and D in CV index; The AUCs ranged from 0.991 to 0.997; For index pAUCs, differences were significant between kits B, D, C ,which had the biggest values, kits A and E which had the lowest ones. For index Se(FPR=e), significant differences were only seen between kits B and A, and B and E (Bootstrap method, P < 0.05).

Conclusion: The diagnostic ability of all the 5 kinds of kits arrange in an order of B, C, D, A and E, from the best to the worst.

Objective: To explore the feasibility and effectiveness of the comprehensive strategies to strengthen the routine immunization program, and to provide the evidence for adjusting the strategies for implementing the project in coming years.

Methods: Five townships were selected from each county according to the location of east, west, south, north and middle. Four villages were selected from each township, and seven children were selected from each village randomly. There were 2215 children were investigated totally.

Results: Compared with results of the baseline survey, the rate of holding immunization card increased from 89.4% to 96.3%. The coverage of 5 kinds of EPI vaccines increased between 10%-35%. The difference of coverage before and after implementing the project was significant P < 0.001. The frequency of cold chain running increased than before implementing the project. The targeted school number of immunization card school entry, the number of children checked, the number of redistributed immunization card, and the number of children catched-up vaccine increased obviously.

Conclusion: The comprehensive strategies of the strengthening routine immunization program have a great effect.