Vaccine Potency

疫苗效力
  • 文章类型: Journal Article
    Recently a new variant of SARS-CoV-2 was reported from South Africa. World Health Organization (WHO) named this mutant as a variant of concern - Omicron (B.1.1.529) on 26th November 2021. This variant exhibited more than thirty amino acid mutations in the spike protein. This mutation rate is exceeding the other variants by approximately 5-11 times in the receptor-binding motif of the spike protein. Omicron (B.1.1.529) variant might have enhanced transmissibility and immune evasion. This new variant can reinfect individuals previously infected with other SARS-CoV-2 variants. Scientists expressed their concern about the efficacy of already existing COVID-19 vaccines against Omicron (B.1.1.529) infections. Some of the crucial mutations that are detected in the receptor-binding domain of the Omicron variant have been shared by previously evolved SARS-CoV-2 variants. Based on the Omicron mutation profile in the receptor-binding domain and motif, it might have collectively enhanced or intermediary infectivity relative to its previous variants. Due to extensive mutations in the spike protein, the Omicron variant might evade the immunity in the vaccinated individuals.
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  • 文章类型: Journal Article
    Influenza is associated with significant morbidity and mortality, especially in older and immunocompromised patients. Few data are available on the clinical benefit of high dose trivalent influenza vaccine (TIV). We aimed to assess the clinical efficacy and safety of high dose TIV.
    We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), evaluating high dose versus standard dose TIV for prevention of seasonal influenza in adult population. Primary outcome was laboratory-confirmed influenza. Subgroups analyses included older adults and immunocompromised patients.
    We included 16 trials, 47,857 patients; 10 included older adults and three immunocompromised patients. Laboratory confirmed influenza was significantly reduced with high dose TIV (relative risk 0.76, 95% confidence interval 0.64 to 0.9). This outcome stemmed mainly from one trial in older adults. Specifically, A(H3N2) laboratory confirmed influenza, but not A(H1N1) or B lineages, was reduced. No difference in mortality or hospitalizations was demonstrated. Immunological response was significantly higher with high dose vaccine. Serious adverse events were significantly less common in the high dose group.
    High dose TIV lowers the rates of laboratory confirmed influenza, mainly A (H3N2), in older adults vs. standard dose. Further studies should address immunocompromised patients and report clinical outcomes.
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  • 文章类型: Journal Article
    In the current context of the pandemic triggered by SARS-COV-2, the immunization of the population through vaccination is recognized as a public health priority. In the case of SARS‑COV‑2, the genetic sequencing was done quickly, in one month. Since then, worldwide research has focused on obtaining a vaccine. This has a major economic impact because new technological platforms and advanced genetic engineering procedures are required to obtain a COVID‑19 vaccine. The most difficult scientific challenge for this future vaccine obtained in the laboratory is the proof of clinical safety and efficacy. The biggest challenge of manufacturing is the construction and validation of production platforms capable of making the vaccine on a large scale.
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  • 文章类型: Journal Article
    在全球范围内将13价肺炎球菌结合疫苗(PCV13)常规引入儿科免疫计划后,血清型3肺炎球菌疾病在人群水平上并未显着下降。这一流行病学发现引起了关于PCV13对抗血清型3疾病的有效性的争论。评估PCV13对血清型3的有效性在成人中尤其重要,其中血清型3构成了剩余肺炎球菌疾病的重要数量。
    我们对已发表的文献进行了系统评价,以评估PCV13对成人血清型3社区获得性肺炎(CAP)的直接有效性。然后,我们使用个体水平的汇总分析来估计总体疫苗有效性(VE),原始数据。
    两项已发表的研究符合纳入标准。其中一项是在荷兰进行的随机对照试验,于2014年发表。另一个是最近在路易斯维尔进行的病例对照研究,肯塔基州使用测试阴性设计(TND)。我们还确定了在阿根廷进行的第三项TND研究,该研究最近作为会议摘要提出,但尚未发表。所有三项研究均在≥65岁的成年人中进行。来自所有三项研究的个体水平数据的汇总分析中,PCV13针对血清型3住院CAP的VE为52.5%(95CI:6.2-75.9%)。如果排除未发表的估计值,则结果相似(血清型3VE=53.6%[95CI:6.7-76.9%])。没有观察到异质性。
    现有证据,尽管仅限于三项研究,提示PCV13在≥65岁的成人中提供对3型血清型住院CAP的直接保护.
    Serotype 3 pneumococcal disease has not substantially declined at the population level after the routine introduction of 13-valent pneumococcal conjugate vaccine (PCV13) into pediatric immunization programs across the globe. This epidemiological finding has generated debate regarding the effectiveness of PCV13 against serotype 3 disease. Evaluating PCV13 effectiveness against serotype 3 is especially critical in adults, where serotype 3 makes up an important amount of remaining pneumococcal disease.
    We performed a systematic review of the published literature to assess the direct effectiveness of PCV13 against serotype 3 community-acquired pneumonia (CAP) among adults. We then estimated overall vaccine effectiveness (VE) using a pooled analysis of the individual-level, raw data.
    Two published studies met inclusion criteria. One was a randomized controlled trial conducted in the Netherlands and published in 2014. The other was a recently-published case-control study conducted in Louisville, Kentucky that used a test-negative design (TND). We also identified a third TND study conducted in Argentina that was recently presented as a conference abstract but is not yet published. All three studies were conducted in adults aged ≥65 years. PCV13 VE against serotype 3 hospitalized CAP was 52.5% (95%CI: 6.2-75.9%) from the pooled analysis of individual-level data from all three studies. Results were similar if the unpublished estimate was excluded (serotype 3 VE = 53.6% [95%CI: 6.7-76.9%]). No heterogeneity was observed.
    Currently-available evidence, although limited to three studies, suggests that PCV13 provides direct protection against serotype 3 hospitalized CAP in adults aged ≥65 years.
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  • 文章类型: Comparative Study
    Background: No head-to-head studies are currently available comparing pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with 13-valent pneumococcal conjugate vaccine (PCV-13). This study explored the feasibility of using network meta-analysis (NMA) to conduct an indirect comparison of the relative efficacy or effectiveness of the two vaccines.Methods: A systematic literature search was conducted for published randomized controlled trials (RCTs) and non-RCT studies reporting data on vaccine efficacy or effectiveness against invasive pneumococcal disease in children aged <5 years receiving 7-valent pneumococcal conjugate vaccine (PCV-7), PHiD-CV or PCV-13. Study quality was evaluated using published scales. NMA feasibility was assessed by considering whether a connected network could be constructed by examining published studies for differences in study or patient characteristics that could act as potential treatment effect modifiers or confounding variables.Results: A total of 26 publications were included; 2 RCTs (4 publications), 7 indirect cohort studies, and 14 case-control studies (15 publications). Study quality was generally good. The RCTs could not be connected in a network as there was no common comparator. The studies differed considerably in design, dose number, administration schedules, and subgroups analyzed. Reporting of exposure status and subject characteristics was inconsistent.Conclusion: NMA to compare the relative efficacy or effectiveness of PHiD-CV and PCV-13 is not feasible on the current evidence base, due to the absence of a connected network across the two RCTs and major heterogeneity between studies. NMA may be possible in future if sufficient RCTs become available to construct a connected network.
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  • 文章类型: Journal Article
    The effectiveness of vaccines is known to be altered by a range of psychological factors. We conducted a systematic review to evaluate the effects of psychological interventions on the ability of vaccines to protect against disease, as measured by antibody responses.
    Electronic databases (EMBASE, Medline, PsychINFO, CINAHL) were searched from their inception to 6th February 2018.
    The search yielded 9 eligible trials conducted with 1603 participants and four broad categories of intervention: meditation/mindfulness (n = 3), massage (n = 3), expressive writing (n = 2) and cognitive behavioural stress management (n = 1). Some evidence of benefit on the antibody response to vaccination was observed in 6/9 of all trials and in 4/7 of randomised controlled trials. However, effects on antibody levels were often mixed, with only 3 of 6 trials showing benefit demonstrating an improvement in all antibody outcomes and at all time points assessed. Trials demonstrating benefit also provided direct or indirect evidence of adequate adherence with the intervention; and in 50% of these trials, there was also evidence that the intervention was effective in changing the mediating psychological constructs targeted by the intervention.
    This literature is characterised by considerable heterogeneity in terms of intervention type, vaccine type, age of participants and the temporal relationship between vaccination and intervention. We conclude that there is early evidence to suggest that psychological interventions may enhance the antibody response to vaccination. However, the effects are inconsistent, with the greatest likelihood of benefit seen in trials evidencing adequate adherence with the intervention. Future work would benefit from rigorous intervention development that focuses on achieving adequate adherence and large well-controlled randomised trials with a focus on an agreed set of outcomes.
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  • 文章类型: Journal Article
    Although a vaccine-preventable disease, influenza causes approximately 3-5 million cases of severe illness and about 290,000-650,000 deaths worldwide, which occur primarily among people 65 years and older. Nonetheless, prevention of influenza and its complications rely mainly on vaccination. We aimed to systematically evaluate influenza vaccine effectiveness at reducing healthcare utilization in older adults, defined as the reduction of outpatient visits, ILI and influenza hospitalizations, utilization of antibiotics and cardiovascular events by vaccination status during the influenza season.
    We searched MEDLINE, EMBASE, CINAHL, Cochrane Library and considered any seasonal influenza vaccine, excluding the pandemic (2009-10 season) vaccine. Reviewers independently assessed data extraction and quality assessment.
    Of the 8308 citations retrieved, 22 studies were included in the systematic review. Overall, two studies (9%) were deemed at moderate risk of bias, thirteen (59%) at serious risk of bias and seven (32%) at critical risk of bias. For outpatient visits, we found modest evidence of protection by the influenza vaccine. For all-cause hospitalization outcomes, we found a wide range of results, mostly deemed at serious risk of bias. The included studies suggested that the vaccine may protect older adults against influenza hospitalizations and cardiovascular events. No article meeting our inclusion criteria explored the use of antibiotics and ILI hospitalizations. The high heterogeneity between studies hindered the aggregation of data into a meta-analysis.
    The variability between studies prevented us from drawing a clear conclusion on the effectiveness of the influenza vaccine on healthcare utilization in older adults. Overall, the data suggests that the vaccine may result in a reduction of healthcare utilization in the older population. Further studies of higher quality are necessary.
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  • 文章类型: Journal Article
    使用循证方法为艾滋病毒感染和艾滋病毒暴露者提供疫苗可预防疾病的疫苗接种建议,但证据有限。我们对随机对照试验(RCT)进行了系统评价和荟萃分析,队列和病例对照研究,以疫苗在HIV感染和HIV暴露儿童中的疗效和有效性作为结局。WebofScience,科克伦图书馆,搜索PubMed和Scopus数据库中的文章。9价肺炎球菌结合疫苗(PCV9)对总疫苗血清型侵袭性肺炎球菌疾病的效力在HIV感染儿童中为32%,在HIV未感染儿童中为78%。卡介苗在预防感染艾滋病毒的儿童结核病方面的疫苗效力为零,而未接触艾滋病毒的儿童的保护率为59%。同样,未感染HIV的儿童比感染HIV的儿童对侵袭性流感嗜血杆菌b型疾病有更好的保护作用。轮状病毒疫苗的有效性研究表明,与未暴露的儿童相比,暴露于HIV的未感染儿童对轮状病毒胃肠炎具有相似的保护作用。严重免疫抑制的儿童对侵袭性肺炎球菌疾病的保护作用较差。与未接触的儿童相比,感染艾滋病毒的儿童对疫苗可预防疾病的疫苗保护程度较低。与免疫抑制的儿童相比,具有免疫能力的HIV感染儿童更有可能对疫苗可预防的疾病提供更好的疫苗保护。观察性研究的总体质量非常低,对效果估计的信心很小。RCT结果的总体证据质量主要较高。这项研究揭示了在HIV感染和暴露儿童中缺乏疗效和有效性研究。
    Evidence-based approaches were used in making recommendations for vaccination against vaccine-preventable diseases for HIV-infected and HIV-exposed individuals but with limited substantiation. We conducted a systematic review and meta-analysis with randomized-controlled trials (RCTs), cohort and case-control studies that have efficacy and effectiveness of vaccines in HIV-infected and HIV-exposed children as outcomes. Web of Science, Cochrane Library, PubMed and Scopus databases were searched for articles. Efficacy of 9-valent pneumococcal conjugate vaccine (PCV9) against total vaccine serotype invasive pneumococcal disease was 32% in HIV-infected children and 78% among HIV-uninfected children. Vaccine effectiveness of Bacillus Calmette-Guérin vaccine in preventing tuberculosis in HIV-infected children was zero compared to 59% protection in HIV-unexposed children. Likewise, HIV-uninfected children have better protection against invasive Haemophilus influenzae type b disease than the HIV-infected children. Effectiveness studies of rotavirus vaccines show that HIV-exposed uninfected children have similar protection against rotavirus gastroenteritis compared to the non-exposed children. Children who are severely immunosuppressed are poorly protected against invasive pneumococcal diseases. HIV-infected children tend to have lesser vaccine protection against vaccine-preventable diseases when compared to unexposed children. HIV-infected children who are immunocompetent are more likely to have better vaccine protection against vaccine-preventable diseases than those who are immunosuppressed. The overall quality of the observational studies was very low with very little confidence in the effect estimate. The overall quality of evidence for the RCT outcomes was mainly high. This study reveals a dearth of efficacy and effectiveness studies among HIV-infected and exposed children.
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  • 文章类型: Journal Article
    除了改善供水和卫生,2剂口服霍乱灭活疫苗(OCV)是预防和控制霍乱的重要工具.我们旨在记录单一OCV剂量对霍乱的免疫原性和保护作用(功效和有效性)。荟萃分析表明,估计有73%和77%的个体血清转化为Ogawa和Inaba血清型,分别,在OCV第一次给药后。根据现有研究,单剂量疫苗保护的估计值在2个月时为87%,在2年时为33%。目前的免疫和临床数据表明,通过单剂量的OCV杀死可能足以降低爆发或其他高风险环境中的短期风险。当疫苗供应有限时,这可能特别有用。然而,直到更多数据表明情况并非如此,一旦情况允许,应给予第二剂,以确保强有力的保护。
    In addition to improved water supply and sanitation, the 2-dose killed oral cholera vaccine (OCV) is an important tool for the prevention and control of cholera. We aimed to document the immunogenicity and protection (efficacy and effectiveness) conferred by a single OCV dose against cholera. The metaanalysis showed that an estimated 73% and 77% of individuals seroconverted to the Ogawa and Inaba serotypes, respectively, after an OCV first dose. The estimates of single-dose vaccine protection from available studies are 87% at 2 months decreasing to 33% at 2 years. Current immunologic and clinical data suggest that protection conferred by a single dose of killed OCV may be sufficient to reduce short-term risk in outbreaks or other high-risk settings, which may be especially useful when vaccine supply is limited. However, until more data suggest otherwise, a second dose should be given as soon as circumstances allow to ensure robust protection.
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  • 文章类型: Journal Article
    Simpler schedules for human papillomavirus (HPV) vaccine delivery could improve vaccine coverage and the effectiveness of cervical cancer prevention. The objective of this study was to systematically review evidence about the effects of two-dose compared with three-dose schedules for human papillomavirus (HPV) vaccine and to describe the uptake of two-dose HPV vaccination schedules globally. We searched PubMed, the Cochrane Central Registry of Controlled Trials, trials registers, and manufacturers\' databases from their earliest date to February 2016. We selected randomised controlled trials and controlled clinical trials that directly compared HPV vaccine schedules with two or three doses. We extracted data on immunological and clinical outcomes and used meta-analysis where appropriate. We also described the use of two-dose HPV vaccine schedules globally. We screened 1464 items and included seven eligible noninferiority trials in 11 countries. In randomised comparisons amongst adolescent girls (three trials), geometric mean concentrations (GMC) of antibodies against HPV16 and HPV18 were non-inferior or inconclusive, up to 24months after a two-dose compared with a three-dose schedule. One trial with a clinical outcome found no persistent HPV infections occurred after either two or three doses. In non-randomised comparisons, GMC were non-inferior or superior in adolescent girls receiving the two-dose schedule compared with women receiving the three-dose schedule for at least 21months after vaccination. By February 2017, 23 low and middle income and 25 high income countries had adopted a two-dose HPV vaccination schedule. A two-dose HPV vaccine schedule provides satisfactory immunological outcomes in adolescent girls, but uptake globally is limited, particularly in countries with the highest burden of cervical cancer.
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