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Objective:To evaluate the post-marketing safety and immunogenicity of a 23-valent pneumococcal polysaccharide vaccine (PPV23).Methods:From September 2020 to June 2021, a clinical trial of single-dose PPV23 was conducted in people ≥3 years old in Centers for Disease Control and Prevention of Guizhou, Hunan and Fujian provinces. Blood samples were collects from the subjects before and 30 d after vaccination. ELISA was used to quantitatively detect IgG antibodies against capsular polysaccharides of 23 Streptococcus pneumoniae serotypes in serum samples. The adverse events (AEs) were monitored within 7 d after vaccination. Results:A total of 409 subjects were enrolled and included in safety analysis. Except for one with antibody level inversion, the other 408 participants were included in immunogenicity analysis. The levels of antibodies against the 23 Streptococcus pneumoniae serotypes were all increased after vaccination by an average of 4.24 folds. The two-fold growth rates of the antibodies ranged from 51.72% to 96.81% with a total two-fold growth rate of 78.59%. The overall rate of AEs was 27.14% (111/409). Local AEs were mainly pain, induration, redness and swollen. No serious adverse events related to vaccination occurred. Conclusions:This study preliminarily demonstrated the good immunogenicity and safety of PPV23 vaccine.
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Objective To analyze functional antibody and protection effect against pneumonia after inoculation with 23-valent pneumococcal polysaccharide vaccine(PPV23)in healthy elderly. Methods In 2015, 48 healthy elderly people aged ≥60 years were randomly selected in Hongkou District of Shanghai, and their blood samples were collected before, and 1 month and 6 months after the inoculation of PPV23.Functional antibodies against 13 serotypes(1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F、23F)of streptococcus pneumonia were determined by muti-specificity opsonophagocyitosis killing assay(MOPA).The incidence of community-acquired pneumonia(CAP)after PPV23 inoculation was also investigated. Results The GMT of OPA antibodies against 13 serotypes were higher 1 and 6 months after inoculation than that before inoculation.One month after the inoculation, OPA antibodies against 13 serotypes ≥2 times growth rate and ≥4 times growth rate were 64.58%-87.00% and 43.75%-75.00%, respectively.Six months after inoculation with PPV23, OPA antibodies against 13 serotypes ≥2 times growth rate and ≥4 times growth rate were 45.71%-82.86%, 40.00%-80.00%, respectively.There was no significant difference in the growth rate of OPA antibody between 6 months and 1 month after vaccination for most serotypes.Results of self-descriptive survey before and after the inoculation showed that the protection against CAP in healthy elderly people in the first and second years after PPV23 inoculation was 100.00% and 50.00%, respectively. Conclusion PPV23 has better immunogenicity and immune persistence after inoculation in healthy elderly people, and has better protective effect against CAP.
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Objective To evaluate the safety of influenza vaccine and 23-valent pneumococcal polysaccharide vaccine (PPV23) immunized alone or in combination in elderly people and to raise the awareness of vaccine safety among the elderly. Methods From October 2014 to September 2015,454 eld-erly people who were over 60 years old and immunized with influenza vaccine and PPV23 alone or in combi-nation were recruited in this study and divided into five groups. Local and systemic reactions occurred within one month after vaccination were recorded. Results (1) Incidences of adverse reactions among all subjects and people vaccinated with influenza vaccine alone,domestic PPV23 alone,imported PPV23 alone,domes-tic PPV23 combined with influenza vaccine and imported PPV23 combined with influenza vaccine were 10.13%,5.35%,11.63 %,9.52%,17.24% and 12.63%,respectively. Local reaction,injection site pain and mild reaction were the common reactions to vaccination. All reactions occurred within seven days and most of them occurred within 30 minutes to one day after vaccination(82.61%). All subjects recovered within seven days and most of them recovered within one day (84.78%). (2) Compared with the people immunized with domestic or imported PPV23 or influenza vaccine alone,those immunized in combination had higher incidences of reactions to vaccination. Among the three single vaccination groups, domestic PPV23 group had the highest incidence of reactions,followed by imported PPV23 and influenza vaccine groups,but no significant difference was found among them(P>0.05). The incidence of responses to influenza vaccine combined with domestic PPV23 was higher than that to influenza vaccine combined with imported PPV23, but no significant difference was found between them (P>0.05). (3) In each group,women,people aged≥70 years or with chronic diseases had a higher incidence of responses to vaccination than men,people aged 60 to 69 years or without chronic diseases,respectively (P>0.05). Conclusion Immunization with influ-enza vaccine and PPV23 alone or in combination is safe and tolerable in elderly people regardless of gender, age,or whether they are suffering from chronic diseases or not. Both domestic and imported PPV23 have the feature of good safety.
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Objective To explore the effect of influenza and 23 valent pneumococcal polysaccharide pneumococcal vaccinations on symptom-improvement among elderly with chronic obstructive pulmonary diseases (COPD).Methods Data was gathered from 4 communities in 3 National Demonstration Areas set for comprehensive prevention and control of chronic non-communicable diseases in Chongqing city and Ningbo city respectively,from November 2013 to October 2014.The communities were selected by cluster sampling and divided into 4 groups:(1) injected influenza vaccines;(2) injected with pneumococcal vaccines;(3) received both of the two vaccines;(4) the control group that without any intervention measures.All the subjects aged from 60 to 75 were selected to fill in demographic information questionnaire and receive (COPD assessment test,CAT) scores twice,before intervention and 1 year after the vaccination.SAS 9.4 software was used to analyze the change of symptoms and CAT scores before and after the intervention program and comparing the improvement on symptoms among the elderly people under study.Results A total of 1 244 subjects with nearly same baseline conditions after the propensity score matching,were involved in this study.CAT scores appeared as Median=21 (IQR:17-26) at baseline.The CAT scores appeared as Median=18 (IQR:14-24),decreasing in all the 3 vaccinated groups,one year after the intervention program (influenza vaccines,matching t test,t=-6.531,P=0.403;pneumococcal vaccines,Wilcoxon test,H=-9 623,P＜0.001;combined vaccine vaccines,matching t test,t=-10.803,P＜0.001).However,in the control group,no obvious change was observed (Wilcoxon H=1 167,P=0.403).Proportions of impacts at high or very high levels all decreased in the 3 intervention groups,while little change was observed in the control group.Outcomes from the Factorial analysis suggested that influenza vaccination could improve the general conditions and symptoms including cough,chest tightness,dyspnea,physical activities,and stamina.Pneumococcal vaccination appeared more effective on all of symptoms and indicators.Conclusion Pneumococcal and influenza vaccination seemed helpful for elderly people suffering COPD to improve the general health condition.
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Objective To explore the effect of influenza and 23 valent pneumococcal polysaccharide pneumococcal vaccinations on symptom-improvement among elderly with chronic obstructive pulmonary diseases (COPD).Methods Data was gathered from 4 communities in 3 National Demonstration Areas set for comprehensive prevention and control of chronic non-communicable diseases in Chongqing city and Ningbo city respectively,from November 2013 to October 2014.The communities were selected by cluster sampling and divided into 4 groups:(1) injected influenza vaccines;(2) injected with pneumococcal vaccines;(3) received both of the two vaccines;(4) the control group that without any intervention measures.All the subjects aged from 60 to 75 were selected to fill in demographic information questionnaire and receive (COPD assessment test,CAT) scores twice,before intervention and 1 year after the vaccination.SAS 9.4 software was used to analyze the change of symptoms and CAT scores before and after the intervention program and comparing the improvement on symptoms among the elderly people under study.Results A total of 1 244 subjects with nearly same baseline conditions after the propensity score matching,were involved in this study.CAT scores appeared as Median=21 (IQR:17-26) at baseline.The CAT scores appeared as Median=18 (IQR:14-24),decreasing in all the 3 vaccinated groups,one year after the intervention program (influenza vaccines,matching t test,t=-6.531,P=0.403;pneumococcal vaccines,Wilcoxon test,H=-9 623,P＜0.001;combined vaccine vaccines,matching t test,t=-10.803,P＜0.001).However,in the control group,no obvious change was observed (Wilcoxon H=1 167,P=0.403).Proportions of impacts at high or very high levels all decreased in the 3 intervention groups,while little change was observed in the control group.Outcomes from the Factorial analysis suggested that influenza vaccination could improve the general conditions and symptoms including cough,chest tightness,dyspnea,physical activities,and stamina.Pneumococcal vaccination appeared more effective on all of symptoms and indicators.Conclusion Pneumococcal and influenza vaccination seemed helpful for elderly people suffering COPD to improve the general health condition.
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Objective To analyze the immunization coverage of 23-valent pneumococcal polysac-charide vaccine(PPV23)in a large population in Guangzhou and to evaluate its safety by analyzing the ad-verse events following immunization(AEFI)reported to the passive surveillance system. Methods Immu-nization data of PPV23 in Guangzhou from 2010 to 2015 were collected from Information Management System of Biological Products and the Information System of Immune Programming of Guangzhou. AEFI reported to the AEFI Information System during 2010 to 2015 was collected for safety evaluation. The collected data were analyzed by using descriptive methodology. Results A total of 621 059 doses of PPV23 were pre-scribed in Guangzhou from 2010 to 2015. Most of the recipients were children younger than 10 years old,ac-counting for 79. 44% . Only 9. 38% of the subjects received PPV23 were older than 60 years. A total of 243 AEFI cases were reported at a rate of 39. 13 cases per 100 000 doses,among which 199 cases(32. 04 / 105 ) showed minor vaccine reactions,25 cases(4. 03 / 105 )occurred adverse events,16 cases(2. 58 / 105 )de-veloped coupled diseases and 3 cases(0. 48 / 105 )were classified as psychogenic reactions. No rare adverse reactions were observed. Conclusion The majority of people immunized with PPV23s in Guangzhou were children,while the immunization coverage among the elderly was relatively low. PPV23 was safe for vaccina-tion as the reported AEFI cases were similar to that of other vaccines.
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OBJECTIVE:To provide theoretical support for the scientific and reasonable policy-making of 23-valent pneumococ-cal polysaccharide vaccine(PPV-23)in elderly. METHODS:Retrieved from CJFD,Wanfang Database,Elsevier and PubMed,lit-erature about the pharmacoeconomics evaluation of PPV-23 in elder were selected and statistically analyzed in respects of cost stud-ies,effect indexes and research perspectives. RESULTS:Totally 13 literatures were included,involving 900 472 patients,who were older than 60 years old. Study locations were mainly Colombia,the United States,Italy,Belgium and China. Study results showed,each additional quality-adjusted life-year(QALY)cost was between $ 9 239-$ 33 000 in respect of cost;cost-effectiveness ratio was between $ 9 239-$ 45 161/QALY in respect of effect indexes. Most researches showed PPV-23 in elderly older than 65 years old had certain cast-effectiveness. Only a research in Netherlands held the idea that PPV-23 in elderly was not considered cost-effectiveness.CONCLUSIONS:Putting PPV-23 inelderly has certain cost-effecctiveness and most countries has put it into nation-al immunization program. The present researches can't ensure the economy of putting ppv-23 in elderly in china,so it needs more researches with high quality to ensure it.
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A 58-year-old female was admitted due to severe sepsis and multi-organ failure with a fulminant purpuric rash. Meropenem, vancomycin and levofloxacin were administered, although no focus of infection was detected. However, computed tomography revealed a profoundly hypoplastic spleen, and a blood smear detected Howell-Jolly bodies. Blood cultures grew <i>Streptococcus pneumoniae</i> (serotype 22F) three hours after admission. The patient was finally diagnosed as overwhelming pneumococcal sepsis with hyposplenism precipitated by splenic hypoplasia. Clinicians should pay attention to the splenic size and Howell-Jolly bodies in cases of sepsis of unknown origin.