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Zhonghua Yu Fang Yi Xue Za Zhi [Chinese... Jul 2020In 1999, since the Rotashield, the first generation of oral Rotavirus vaccine has been confirmed that there is a link to intussusception, mainly occurs in 7 days after...
In 1999, since the Rotashield, the first generation of oral Rotavirus vaccine has been confirmed that there is a link to intussusception, mainly occurs in 7 days after first dose. With the second generation of RV vaccine has been listed globally and intussusception monitoring has continued. This study reviewed the current phase Ⅲ clinical and post-marketing studies of rotavirus vaccines on the market and found that the two most widely used rotavirus vaccines, RV1 and RV5, were found the risk of intussusception increased within 7 days of ORV. The Lanzhou lamb rotavirus vaccine (LLR), which manufactured by Lanzhou Institute of Biological Products Co, also lacks Epidemiological surveies. With the introduction of RV5 in 2018, the role of rotavirus vaccine in the prevention and efforts of severe rotavirus diarrhea is increasing. It is urgent to establish an intussusception active monitoring system to monitor the incidence of intussusception after rotavirus vaccine and provide more evidence for the post-marketing evaluation of the rotavirus vaccine.
Topics: Humans; Infant; Intussusception; Rotavirus; Rotavirus Infections; Rotavirus Vaccines; Vaccines, Attenuated
PubMed: 32842305
DOI: 10.3760/cma.j.cn112150-20191115-00860 -
The Cochrane Database of Systematic... Jun 2018Influenza vaccinations are currently recommended in the care of people with COPD, but these recommendations are based largely on evidence from observational studies,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Influenza vaccinations are currently recommended in the care of people with COPD, but these recommendations are based largely on evidence from observational studies, with very few randomised controlled trials (RCTs) reported. Influenza infection causes excess morbidity and mortality in people with COPD, but there is also the potential for influenza vaccination to cause adverse effects, or not to be cost effective.
OBJECTIVES
To determine whether influenza vaccination in people with COPD reduces respiratory illness, reduces mortality, is associated with excess adverse events, and is cost effective.
SEARCH METHODS
We searched the Cochrane Airways Trials Register, two clinical trials registries, and reference lists of articles. A number of drug companies we contacted also provided references. The latest search was carried out in December 2017.
SELECTION CRITERIA
RCTs that compared live or inactivated virus vaccines with placebo, either alone or with another vaccine, in people with COPD.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data. All entries were double-checked. We contacted study authors and drug companies for missing information. We used standard methods expected by Cochrane.
MAIN RESULTS
We included 11 RCTs with 6750 participants, but only six of these included people with COPD (2469 participants). The others were conducted on elderly and high-risk individuals, some of whom had chronic lung disease. Interventions compared with placebo were inactivated virus injections and live attenuated intranasal virus vaccines. Some studies compared intra-muscular inactivated vaccine and intranasal live attenuated vaccine with intra-muscular inactivated vaccine and intranasal placebo. Studies were conducted in the UK, USA and Thailand.Inactivated vaccine reduced the total number of exacerbations per vaccinated participant compared with those who received placebo (mean difference (MD) -0.37, 95% confidence interval (CI) -0.64 to -0.11; P = 0.006; two RCTs, 180 participants; low quality evidence). This was due to the reduction in 'late' exacerbations, occurring after three or four weeks (MD -0.39, 95% CI -0.61 to -0.18; P = 0.0004; two RCTs, 180 participants; low quality evidence). Both in people with COPD, and in older people (only a minority of whom had COPD), there were significantly more local adverse reactions in people who had received the vaccine, but the effects were generally mild and transient.There was no evidence of an effect of intranasal live attenuated virus when this was added to inactivated intramuscular vaccination.Two studies evaluating mortality for influenza vaccine versus placebo were too small to have detected any effect on mortality. However, a large study (N=2215) noted that there was no difference in mortality when adding live attenuated virus to inactivated virus vaccination, AUTHORS' CONCLUSIONS: It appeared, from the limited number of RCTs we were able to include, all of which were more than a decade old, that inactivated vaccine reduced exacerbations in people with COPD. The size of effect was similar to that seen in large observational studies, and was due to a reduction in exacerbations occurring three or more weeks after vaccination, and due to influenza. There was a mild increase in transient local adverse effects with vaccination, but no evidence of an increase in early exacerbations. Addition of live attenuated virus to the inactivated vaccine was not shown to confer additional benefit.
Topics: Aged; Disease Progression; Humans; Influenza Vaccines; Influenza, Human; Lung Diseases, Obstructive; Randomized Controlled Trials as Topic; Vaccines, Attenuated; Vaccines, Inactivated
PubMed: 29943802
DOI: 10.1002/14651858.CD002733.pub3 -
The Cochrane Database of Systematic... Mar 2014Viral respiratory tract infections in people with cystic fibrosis have a deteriorating effect on their lung function and disease progression. Annual influenza... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Viral respiratory tract infections in people with cystic fibrosis have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for people with cystic fibrosis.
OBJECTIVES
To assess the effectiveness of influenza vaccination for people with cystic fibrosis.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and handsearching of relevant journals and abstract books of conference proceedings. We also contacted the companies which market the influenza vaccines used in the trials to obtain further information about randomised controlled trials.Date of the most recent search of the Cochrane Cystic Fibrosis and Genetic Disorders Group's Cystic Fibrosis Trials Register: 08 July 2013.
SELECTION CRITERIA
All randomised and quasi-randomised trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed study quality and extracted data. Additional information was obtained by contacting the investigators when it was indicated.
MAIN RESULTS
Four studies enrolling a total of 179 participants with cystic fibrosis (143 (80%) were children aged 1 to 16 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a subunit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and the other two studies compared a split virus to a subunit vaccine and a virosome to a subunit vaccine (all intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48 out of 201 participants (24%) for the intranasal live vaccine to 13 out of 30 participants (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No study reported other clinically important benefits.
AUTHORS' CONCLUSIONS
There is currently no evidence from randomised studies that influenza vaccine given to people with cystic fibrosis is of benefit to them. There remains a need for a well-constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.
Topics: Adolescent; Child; Child, Preschool; Cystic Fibrosis; Humans; Infant; Influenza Vaccines; Influenza, Human; Randomized Controlled Trials as Topic; Vaccines, Attenuated; Vaccines, Inactivated
PubMed: 24604671
DOI: 10.1002/14651858.CD001753.pub3 -
Human Vaccines & Immunotherapeutics Feb 2017Asplenic or hyposplenic (AH) individuals are particularly vulnerable to invasive infections caused by encapsulated bacteria. Such infections have often a sudden onset... (Review)
Review
Asplenic or hyposplenic (AH) individuals are particularly vulnerable to invasive infections caused by encapsulated bacteria. Such infections have often a sudden onset and a fulminant course. Infectious diseases (IDs) incidence in AH subjects can be reduced by preventive measures such as vaccination. The aim of our work is to provide updated recommendations on prevention of infectious diseases in AH adult patients, and to supply a useful and practical tool to healthcare workers for the management of these subjects, in hospital setting and in outpatients consultation. A systematic literature review on evidence based measures for the prevention of IDs in adult AH patients was performed in 2015. Updated recommendations on available vaccines were consequently provided. Vaccinations against S. pneumoniae, N. meningitidis, H. influenzae type b and influenza virus are strongly recommended and should be administered at least 2 weeks before surgery in elective cases or at least 2 weeks after the surgical intervention in emergency cases. In subjects without evidence of immunity, 2 doses of live attenuated vaccines against measles-mumps-rubella and varicella should be administered 4-8 weeks apart from each other; a booster dose of tetanus, diphtheria and pertussis vaccine should be administered also to subjects fully vaccinated, and a 3-dose primary vaccination series is recommended in AH subjects with unknown or incomplete vaccination series (as in healthy people). Evidence based prevention data support the above recommendations to reduce the risk of infection in AH individuals.
Topics: Adult; Disease Transmission, Infectious; Humans; Immunologic Deficiency Syndromes; Orthomyxoviridae; Splenic Diseases; Vaccination; Vaccines
PubMed: 27929751
DOI: 10.1080/21645515.2017.1264797 -
Vaccine Nov 2007We undertook a systematic review and meta-analysis of randomised controlled trials comparing a typhoid fever vaccine with any alternative typhoid fever vaccine or... (Meta-Analysis)
Meta-Analysis Review
We undertook a systematic review and meta-analysis of randomised controlled trials comparing a typhoid fever vaccine with any alternative typhoid fever vaccine or inactive agent. Trials evaluating killed whole-cell vaccines were excluded. The cumulative efficacy at 3 years for the Ty21a and the polysaccharide Vi vaccine were similar: 51% (95%CI 36%, 62%), and 55% (95%CI 30%, 70%), respectively. The cumulative efficacy of the Vi-rEPA vaccine at 3.8 years was higher, 89% (95%CI 76%, 97%), but this vaccine has not yet been licensed for use and was evaluated in only one trial. Adverse events were mild in nature and for most, not significantly more frequent in any of the vaccine groups when compared with placebo. Both the currently licensed Ty21a and Vi vaccine, are safe and efficacious for preventing typhoid fever. Neither vaccine is currently registered for administration to children below 2 years of age. Given the recent finding that typhoid fever also affects infants, development of a conjugate vaccine is warranted.
Topics: Child; Child, Preschool; Humans; Randomized Controlled Trials as Topic; Salmonella typhi; Typhoid Fever; Typhoid-Paratyphoid Vaccines; Vaccines, Attenuated
PubMed: 17928109
DOI: 10.1016/j.vaccine.2007.08.027 -
Epidemiology and Infection Feb 2013Shigella is an important bacterial cause of infectious diarrhoea globally. The Shigella human challenge model has been used since 1946 for a variety of objectives... (Review)
Review
Shigella is an important bacterial cause of infectious diarrhoea globally. The Shigella human challenge model has been used since 1946 for a variety of objectives including understanding disease pathogenesis, human immune responses and allowing for an early assessment of vaccine efficacy. A systematic review of the literature regarding experimental shigellosis in human subjects was conducted. Summative estimates were calculated by strain and dose. While a total of 19 studies evaluating nine strains at doses ranging from 10 to 1 × 1010 colony-forming units were identified, most studies utilized the S. sonnei strain 53G and the S. flexneri strain 2457T. Inoculum solution and pre-inoculation buffering has varied over time although diarrhoea attack rates do not appear to increase above 75-80%, and dysentery rates remain fairly constant, highlighting the need for additional dose-ranging studies. Expansion of the model to include additional strains from different serotypes will elucidate serotype and strain-specific outcome variability.
Topics: Diarrhea; Dysentery, Bacillary; Epidemiologic Research Design; Human Experimentation; Humans; Incidence; Shigella; Shigella Vaccines; Shigella dysenteriae; Shigella flexneri; Shigella sonnei
PubMed: 22906296
DOI: 10.1017/S0950268812001677 -
The Cochrane Database of Systematic... Jul 2007Vaccination is recognized as the only practical measure for preventing Japanese encephalitis. Production shortage, costs, and issues of licensure impair vaccination... (Review)
Review
BACKGROUND
Vaccination is recognized as the only practical measure for preventing Japanese encephalitis. Production shortage, costs, and issues of licensure impair vaccination programmes in many affected countries. Concerns over vaccine effectiveness and safety also have a negative impact on acceptance and uptake.
OBJECTIVES
To evaluate vaccines for preventing Japanese encephalitis in terms of effectiveness, adverse events, and immunogenicity.
SEARCH STRATEGY
In March 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2007, Issue 1), MEDLINE, EMBASE, LILACS, BIOSIS, and reference lists. We also attempted to contact corresponding authors and vaccine companies.
SELECTION CRITERIA
Randomized controlled trials (RCTs), including cluster-RCTs, comparing Japanese encephalitis vaccines with placebo (inert agent or unrelated vaccine), no intervention, or alternative Japanese encephalitis vaccine.
DATA COLLECTION AND ANALYSIS
Authors independently extracted data and assessed methodological quality. Dichotomous data were compared with relative risks and a 95% confidence interval (CI), and converted into percentage vaccine efficacy.
MAIN RESULTS
Eight RCTs involving 358,750 participants were included. These trials investigated two available and three pre-licensure vaccines. Two RCTs assessing efficacy of the commercially available inactivated Nakayama vaccine were identified. A two-dose schedule of the licensed vaccine provided significant protection of 95% (95% CI 10% to 100%) for one year only, while two doses of an unpurified precursor vaccine protected children by 81% (95% CI 45% to 94%) in year one and by 59% (95% CI 2% to 83%) in year two. Serious adverse events were not observed. Mild and moderate episodes of injection site soreness, fever, headache, and nausea were reported in less than 6% of children receiving inactivated vaccine compared to 0.6% of unvaccinated controls. One cluster-RCT compared the live-attenuated SA14-14-2 vaccine (widely used in China) with no intervention measuring adverse events. Fever was reported in 2.7% of vaccinees compared to 3.1% of controls, while 0.1% of both groups suffered diarrhoea or seizures. Four small pre-licensure RCTs assessing a genetically engineered vaccine and two cell culture-derived inactivated vaccines revealed high immunogenicity and relative safety.
AUTHORS' CONCLUSIONS
Only one of the three currently used vaccines has been assessed for efficacy in a RCT. Other RCTs have assessed their safety, however, and they appear to cause only occasional mild or moderate adverse events. Further trials of effectiveness and safety are needed for the currently used vaccines, especially concerning dose levels and schedules. Trials investigating several new vaccines are planned or in progress.
Topics: Encephalitis, Japanese; Humans; Japanese Encephalitis Vaccines; Randomized Controlled Trials as Topic; Vaccines, Attenuated; Vaccines, Inactivated
PubMed: 17636750
DOI: 10.1002/14651858.CD004263.pub2 -
Viruses Nov 2022The outbreak of monkeypox, coupled with the onslaught of the COVID-19 pandemic is a critical communicable disease. This study aimed to systematically identify and review... (Review)
Review
The outbreak of monkeypox, coupled with the onslaught of the COVID-19 pandemic is a critical communicable disease. This study aimed to systematically identify and review research done on preclinical studies focusing on the potential monkeypox treatment and immunization. The presented juxtaposition of efficacy of potential treatments and vaccination that had been tested in preclinical trials could serve as a useful primer of monkeypox virus. The literature identified using key terms such as monkeypox virus or management or vaccine stringed using Boolean operators was systematically reviewed. Pubmed, SCOPUS, Cochrane, and preprint databases were used, and screening was performed in accordance with PRISMA guidelines. A total of 467 results from registered databases and 116 from grey literature databases were screened. Of these results, 72 studies from registered databases and three grey literature studies underwent full-text screening for eligibility. In this systematic review, a total of 27 articles were eligible according to the inclusion criteria and were used. Tecovirimat, known as TPOXX or ST-246, is an antiviral drug indicated for smallpox infection whereas brincidofovir inhibits the viral DNA polymerase after incorporation into viral DNA. The ability of tecovirimat in providing protection to poxvirus-challenged animals from death had been demonstrated in a number of animal studies. Non-inferior with regard to immunogenicity was reported for the live smallpox/monkeypox vaccine compared with a single dose of a licensed live smallpox vaccine. The trial involving the live vaccine showed a geometric mean titre of vaccinia-neutralizing antibodies post two weeks of the second dose of the live smallpox/monkeypox vaccine. Of note, up to the third generation of smallpox vaccines-particularly JYNNEOS and Lc16m8-have been developed as preventive measures for MPXV infection and these vaccines had been demonstrated to have improved safety compared to the earlier generations.
Topics: Animals; Humans; Mpox (monkeypox); Smallpox Vaccine; Smallpox; Pandemics; COVID-19; Monkeypox virus; Variola virus; Vaccinia virus; Vaccines, Attenuated; COVID-19 Drug Treatment
PubMed: 36423105
DOI: 10.3390/v14112496 -
Beni-Suef University Journal of Basic... 2022Hand, foot, and mouth disease (HFMD) is a viral infection caused by a virus from the enterovirus genus of picornavirus family that majorly affects children. Though most... (Review)
Review
BACKGROUND
Hand, foot, and mouth disease (HFMD) is a viral infection caused by a virus from the enterovirus genus of picornavirus family that majorly affects children. Though most cases of HFMD do not cause major problems, the outbreaks of Enterovirus 71 (EV71) can produce a high risk of neurological sequelae, including meningoencephalitis, lung difficulties, and mortality. In Asia, HFMD caused by EV71 has emerged as an acutely infectious disease of highly pathogenic potential, which demands the attention of the international medical community.
MAIN BODY OF THE ABSTRACT
Some online databases including NCBI, PubMed, Google Scholar, ProQuest, Scopus, and EBSCO were also accessed using keywords relating to the topic for data mining. The paid articles were accessed through the Centre Library facility of Siksha O Anusandhan University. This work describes the structure, outbreak, molecular epidemiology of Enterovirus 71 along with different EV71 vaccines. Many vaccines have been developed such as inactivated whole-virus live attenuated, subviral particles, and DNA vaccines to cure the patients. In Asia-Pacific nations, inactivated EV71 vaccination still confronts considerable obstacles in terms of vaccine standardization, registration, price, and harmonization of pathogen surveillance and measurements.
SHORT CONCLUSION
HFMD has emerged as a severe health hazard in Asia-Pacific countries in recent decades. In Mainland China and other countries with high HFMD prevalence, the inactivated EV71 vaccination will be a vital tool in safeguarding children's health. When creating inactivated EV71 vaccines, Mainland China ensured maintaining high standards of vaccine quality. The Phase III clinical studies were used to confirm the safety and effectiveness of vaccinations.
PubMed: 35730010
DOI: 10.1186/s43088-022-00258-4 -
Vaccine Apr 2020As the real-world effectiveness of quadrivalent live attenuated influenza vaccine (LAIV4) and inactivated influenza vaccine (IIV) has varied in recent seasons, a... (Meta-Analysis)
Meta-Analysis
As the real-world effectiveness of quadrivalent live attenuated influenza vaccine (LAIV4) and inactivated influenza vaccine (IIV) has varied in recent seasons, a systematic review and meta-analysis was conducted to more precisely estimate effectiveness in the 2016-2017 season. Relevant studies were identified from a systematic review of published literature and personal communication with study investigators. Five studies conducted in Canada, Finland, Germany, the United Kingdom, and the United States were identified for inclusion. Data were analyzed using a random effects model, with heterogeneity testing and a sensitivity analysis restricted to test-negative case-control studies. Consolidated vaccine effectiveness estimates against all strains were 69% (95% CI: 46 to 82) for LAIV4 and 47% (95% CI: 29 to 61) for IIV. Heterogeneity testing was not statistically significant, indicating consistency of individual study results. In conclusion, LAIV4 and IIV showed moderate and comparable effectiveness against influenza in children during the 2016-2017 influenza season.
Topics: Canada; Child; Finland; Germany; Humans; Influenza Vaccines; Influenza, Human; Seasons; United Kingdom; United States; Vaccines, Attenuated; Vaccines, Inactivated
PubMed: 31917037
DOI: 10.1016/j.vaccine.2019.12.015