Safety and Immunogenicity of Domestic Split-virion Influenza Vaccine
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Objective To evaluate the safety and immunogenicity of the domestic split-virion influenza vaccine.Methods An open designed clinical trial was performed in 322 subjects in Jianhu of Yancheng city,Jiangsu Province to investigate its safety, seroconversion rate,geometric mean titer (GMT) and seroprotection rate.Results After immunization,the systemic and local reaction rates were 4.52% and 0.6%.319 subjects were assessed in immunogenicity after vaccination.The anti-HI seroconversion rates of H1N1, H3N2 and B hypotype were 94.98%,87.1% and 88.1%,respectively.The anti-HI GMT showed 33.5-time.7.8-time.and 26.2-time.increase,respectively.The anti-HI seroprotection rates were 100% ,99.7% and 98.4% respectively.Conclusion The domestic split-virion influenza vaccine has excellent safety and immunogenicity,and it is suitable for wide use.Keywords:
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Objective To study safety and immunogenicity of the influenza vaccine for children (Pastedur Merieux Biological Products Co.,Ltd).Methods Sixty-nine children aged below three years were selected randomly living in suburb of Tianjin city and vaccinating the influenza vaccine.Results The local-reaction rate was 2.9% and the systemic-reaction rate was 7.2%. The antibody positive rate of the influenza type H1N1,type H3N2 and type B was 83.7% , 77.6% and 85.7% respectively after vaccination.The rate of antibody titer for three type ≥1∶40,were 95.9%,95.9%, 38.8% respectively.Conclusion The vaccine was safe and the immunity of the influenza vaccine was good except type B.
Antibody titer
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To evaluate the safety and immunogenicity of seasonal inactivated influenza vaccine (split virion) and to analyze its cross-reactive antibody responses to H7N9 avian influenza virus.An open-labeled clinical trial was carried out in infants aged 6-35 months, adults aged 18-60 years and the elderly aged >60 years. After vaccinations (one dose for adults and the elderly and two doses for infants), adverse events were observed. Serum samples were obtained before vaccination and 21 days after vaccination from adults and elderly subjects. Three types of antibody against seasonal influenza virus and antibody against H7N9 avian influenza virus were tested using microhemagglutination inhibition (HI) assay. Immunogenicity of the vaccine was evaluated based on the immunogenicity criteria for adults and the elderly, set by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency.A total of 202 subjects (65 infants, 69 adults and 68 elderly) were enrolled and injected for at least one dose. The overall rate of adverse events was 12.4% (25/202) and most of them were under systemic reaction. No serious adverse event was reported. Pre- and post-vaccination serum samples were collected from 124 subjects (64 adults, 60 elderly). After 21 days of vaccination, the sero-conversion rate, sero-protection rate, and geometric mean titer (GMT) ratio (post-/pre-vaccination) of antibody against seasonal influenza virus were 78.1%-90.6%, 92.2%-100.0% and 7.9-41.0 among adults while 66.7%-83.3%, 86.7%-100.0% and 5.7-20.4 among the elderly, respectively. However, after vaccination, both sero-conversion rate and sero-protection rate of antibody against H7N9 avian influenza virus among adults and the elderly became zero, with GMT ratio between 1.2 and 1.4.This trial vaccine appeared to have good safety and immunogenicity but inducing no cross-reactive antibody response to H7N9 avian influenza virus.
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Objective To assess the influence of pre-vaccination antibody titer on immunogenicity of the influenza A H1N1 vaccine,to provide reference of vaccine immunogenicity strategies.Methods The data in clinic trial of the influenza A H1N1 vaccine were analyzed.To find the influence of pre-vaccination antibody titer of vaccine immunogenicity.Results 5901 participants were enrolled in the trials and received 15μg split-virus vaccine without aluminium adjuvant.At base line,the hemagglutination inhibition antibody titer was lower than other reports at the baseline data.The seroconversion rate reduced in the participants who had high antibody titre on the day 0.The study showed that all vaccine were immunogenic.The antibody titer at pre-vaccination has no relationship to seroprotection rate after first dose vaccination.Conclusion Further researches were needed to find the influence of pre-vaccination antibody titer on the seroconversion rate.There was no need to consider the antibody titer on day 0 before the vaccination.During the influenza A H1N1 pandemic,whole population were suggested to receive the vaccine to increase the seroprotection rate.
Seroconversion
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Objective To evaluate the safety and immunogenicity of domestic split influenza virus vaccine which advanced in 2007 by Shanghai Institute of Biological Products. Methods A random study was carried out in Sheyang County,Jiangsu Province and 500 subjects were selected. Results After immunization,the systemic and local reaction rates of domestic split influenza vaccine were 1.5% and 4.67%,respectively. The seroconversion rates of antibodies HI titers of H1N1,H3N2,and B were 99.13%,99.13%,and 100%,respectively. Antibodies HI titers rose four-fold,which were more than 78% in all groups except the group aged between 13 and 17 years of H3N2 (52.83%). The HI geometric mean titers (GMT) were all increased 3.9 folds in all groups. Conclusions Clinical trial indicates that the safety of split influenza virus vaccine has reached a satisfactory level.
Seroconversion
Antibody titer
Systemic reaction
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Post-marketing evaluation on the safety and immunogenicity of domestic split influenza virus vaccine
Objective To evaluate the safety and immunogenicity of post-marketing domestic split influenza virus vaccine. Methods A multicenter, randomized, controlled clinical trial was conducted in Changge, Yuzhou and Dengfeng, Henan province during August~ October, 2011. 6 171 healthy persons were divided into vaccine group and control group randomly. Each one was inoculated one dose of vaccine in vaccination group. The control group did not receive any treatment. The adverse reaction rates between vaccination group and control group were compared. In vaccination group,599 cases were randomly selected as evaluation objects for immune effects. The blood samples were collected before immunization and 28 days after immunization. The antibodies were measuredby hemagglutination inhibition(HI)test. Results The systemic and local reaction rates in vaccination group were 7.14 %(220/3083)and 1.36 %( 42/3083). Systemic reaction rate in control group was 1.17 %(36/3088). There was no local reaction in control group. The systemic and local reaction rates in vaccination group were significantly higher than those in control group(χ2=138.285, P0.001 χ2=42.356, P0.001). The antibody positive rates of H1N1, H3N2 and B in vaccine group were 79.30 %, 82.80 and 67.60 %, respectively. The antibody protective rates of H1N1, H3N2 and B were 89.30 %, 98.30 % and 93.00 %, respectively. The geometric mean titers were 1∶416, 1∶796 and 1∶180, respectively. Conclusions The domestic influenza split vaccine has good safety and immunogenicity, and might be suitable for mass vaccination.
Hemagglutination assay
Trivalent influenza vaccine
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Objective To evaluate the safety and immunogenicity of domestic split influenza virus vaccine.Methods A random and double-blind study was carried out in Lishui,Jiangsu Province to compare the safety,seroconversion rates,and geometric mean titer(GMT) increase of the domestic split influenza vaccine with that of the same kind of vaccine imported from Aventis and Pasteur used as control.Results After immunization,the systemic and local reaction rates of domestic split influenza vaccine were 2.92% and 3.41%,respectively,which was no statistically significant with control vaccine.Except a lower immunogenicity of H_3N_2 strain was observed in domestic split influenza vaccine than in control vaccine,no significant difference was found in the result of immunogenicity assay between the two vaccines.There were no less than 94.9% of susceptive subjects seroprotected,more than 45.9% of no-susceptive subjects whose antibodies HI titers has four-foldrise and the HI geometric mean titers(GMT)were all increased 5.1-18.7 folds.Conclusion These clearly demonstrate that the domestic split influenza vaccine has same result in safety and immunogenicity compared with the imported vaccine.
Seroconversion
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Seroconversion
Hemagglutination assay
Inactivated vaccine
Pandemic
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Objective To evaluate the immunization effects and safety of influenza A(H1N1) vaccine in health population.Methods A total of 350 subjects were chosen by cluster and random sampling and equally divided into seven age groups.Antibody titers were measured by hemagglutination inhibition assay in 30 days after vaccination.And the safety and efficacy of the vaccine were evaluated by descriptive epidemiolegical methods.The incidence,visiting rate and seroconversion rate of influenza A(H1N1) were compared to those of seasonality influenza by SPSS16.0 software.Results The incidence rate of influenza A(H1N1) and seasonality influenza of the vaccination groups were lower than the control group and the difference had the statistical significance(P0.05).Of 43440 cases 1891 cases were reported for vaccine adverse reaction and the total adverse reaction rate was 4.35%.The positive rate of HI antibody vaccination group was significantly higher than the control group(χ2=4.27,P0.05).Conclusions The influenza A(H1N1) vaccine that made in China had good safety and immunogenicity and was suitablo for universal vaccination in the healthy population.
Seroconversion
Hemagglutination assay
Trivalent influenza vaccine
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The producers of influenza vaccines are not capable today to meet the global demand for an influenza vaccine in case of pandemic, so the World Health Organization recommends to develop the own influenza vaccine production in each country. A domestic preservative- and adjuvant-free trivalent split vaccine against seasonal influenza was developed at the Research Institute for Biological Safety Problems. The paper presents the results of assessing safety and immunogenicity of the influenza split vaccine after single immunization of healthy volunteers aged 18-50 years in the course of Phase I Clinical Trials. This study was randomized, blind, and placebo-controlled. The volunteers were intramuscularly vaccinated with a dose of split vaccine or placebo. The study has shown that all local and systemic reactions had low degree of manifestation and short-term character, so there was no need in medication. Serious side effects were not observed. On day 21 post vaccination the portion of vaccinated persons with fourfold seroconversions to influenza А/H1N1pdm09 virus was 100.0%, to influenza А/H3N2 virus-95.5%, to influenza B virus-81.8%, and in placebo group this index was 0%. Seroprotection rates against influenza А/H1N1pdm09, А/H3N2 and B viruses were 95.5, 86.3, and 72.7%, respectively. Geometric mean titers (GMT) of antibodies by day 21 post vaccination reached 175.7 for influenza А/H1N1pdm09 virus, 64.2 for influenza А/H3N2 virus, and 37.6 for influenza B virus; in placebo group GMT growth was not observed. So, the seasonal influenza split vaccine is well tolerated and fits all immunogenicity criteria for human influenza vaccines.
Seasonal influenza
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Objective To evaluate the safety and immunogenicity of Changshengkeji frozen-dried live attenuated varicella vaccine.Methods A randomized,double-blind study was carried out in 720 children aged 1-12 years in Lianshui,Jiangsu Province to compare the safety,seroconversion rates and geometric mean titer(GMT)increase of the testing vaccine vs domestic vaccine as control.Results After immunization,the systemic and local reaction rates of the testing vaccine were 8.33% and 2.08% respectively.The GMT of antibody of children was 1∶52.23,and the seroconversion rates or success rate was 97.12%.No significant statistical difference was found in the results between the two vaccines.ConclusionThe safety and immunogenicity of Changshengkeji frozen-dried live attenuated varicella vaccine is as good as the same kind domestic vaccine.
Seroconversion
Chickenpox Vaccine
Attenuated vaccine
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