Abstract:
BACKGROUND:23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. OBJECTIVE:To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. METHODS:We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. RESULTS:During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. CONCLUSIONS:We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.
journal_name
Vaccinejournal_title
Vaccineauthors
Miller ER,Moro PL,Cano M,Lewis P,Bryant-Genevier M,Shimabukuro TTdoi
10.1016/j.vaccine.2016.04.021subject
Has Abstractpub_date
2016-05-27 00:00:00pages
2841-6issue
25eissn
0264-410Xissn
1873-2518pii
S0264-410X(16)30150-5journal_volume
34pub_type
杂志文章相关文献
VACCINE文献大全abstract::We have examined the efficacy of nucleic acid vaccination in inducing immunity to the multicellular parasite, Schistosoma japonicum, a trematode worm responsible for causing schistosomiasis in humans and other mammalian species. A panel of Schistosoma japonicum cDNAs were cloned into eukaryotic expression vectors, inj...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(96)00258-7
更新日期:1997-06-01 00:00:00
abstract:OBJECTIVE:We assessed knowledge and practices regarding immunization guidelines and the Florida Certificate of Immunization (DH-680) based on FL-DOH and CDC recommendations, to identify the cause of the increasing number of erroneously issued temporary medical exemptions (TME) among selected health care providers in Mi...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2014.06.041
更新日期:2014-07-31 00:00:00
abstract::Selection bias is of critical concern in the study of influenza vaccine effectiveness when using an observational study design. This bias is attributable to the inherently different characteristics between vaccinees and non-vaccinees. The differences, which are related both to vaccination and signs of clinical disease...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2008.06.038
更新日期:2008-11-25 00:00:00
abstract:BACKGROUND:Timely vaccine supply is critical during influenza pandemics. A recombinant hemagglutinin (rHA)-based vaccine could overcome production hurdles of egg-based vaccines but has never previously been tested in a real-life pandemic setting. The primary aim was to determine the efficacy of a recombinant pandemic v...
journal_title:Vaccine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/j.vaccine.2012.06.009
更新日期:2012-08-03 00:00:00
abstract::Nowadays health care worker (HCW) vaccination is widely recommended. Although the benefits of this strategy have been demonstrated in long-term care settings, no studies have been performed in regular hospital departments. We adapt a previously developed model of influenza transmission in a long-term care nursing home...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.07.104
更新日期:2009-10-19 00:00:00
abstract:OBJECTIVE:To compare the use of four different social media sites to recruit men who have sex with men (MSM) and transgender women to a phase 2b HIV prevention vaccine trial, HVTN 505. DESIGN:Retrospective, observational study. METHODS:The University of Pennsylvania HIV Vaccine Trials Unit (Penn HVTU) employed street...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2017.05.002
更新日期:2017-06-14 00:00:00
abstract::Immune responses to the infectious bronchitis virus (IBV) nucleocapsid protein were studied using a recombinant-DNA expression product. In mice, a lymphocyte proliferative response and a delayed-type hypersensitivity reaction to IBV were induced upon immunization with this nucleocapsid protein. Next, we studied the ro...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/0264-410x(92)90028-i
更新日期:1992-01-01 00:00:00
abstract::Foot-and-mouth disease virus (FMDV) is the etiological agent of a highly contagious disease that affects cloven-hoofed animal species. The FMDV capsid is highly acid labile and viral particles lose their immunogenicity when they disassemble at mildly acidic pHs. The viral capsid of FMDV serotype O is more sensitive th...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2019.02.032
更新日期:2019-03-28 00:00:00
abstract::Host antiviral genes are important regulators of antiviral immunity and plausible genetic determinants of immune response heterogeneity after vaccination. We genotyped and analyzed 307 common candidate tagSNPs from 12 antiviral genes in a cohort of 745 schoolchildren immunized with two doses of measles-mumps-rubella (...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.09.043
更新日期:2011-11-08 00:00:00
abstract::Using HIV-1 envelope protein (Env)-based immunogens that closely mimic the conformation of functional HIV-1 Envs and represent the isolates prevalent in relevant geographical region is considered a rational approach towards developing HIV vaccine. We recently reported that like clade B Env, JRFL, membrane bound Indian...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2018.01.081
更新日期:2018-03-14 00:00:00
abstract::Salmonella spp. are facultative intracellular pathogens causing localised or systemic infections, in addition to a chronic asymptomatic carrier state. They are of worldwide economic and public health significance. In poultry, which represent important sources of cheap protein throughout the world, fowl typhoid and pul...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/s0264-410x(99)00060-2
更新日期:1999-06-04 00:00:00
abstract:BACKGROUND AND AIMS:Although two antigenically distinct B strain lineages of influenza have co-circulated globally since the mid-1980s, trivalent influenza vaccines (TIVs) contain only one, resulting in frequent mismatches. This study examined the safety and immunogenicity of an inactivated quadrivalent influenza vacci...
journal_title:Vaccine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.vaccine.2013.08.069
更新日期:2013-11-12 00:00:00
abstract::Immunization with xenogeneic DNA is a promising cancer treatment to overcome tolerance to self-antigens. Heat shock protein 70 (HSP70) is over-expressed in various kinds of tumors and is believed to be involved in tumor progression. This study tested a xenogeneic chicken HSP70 (chHSP70) DNA vaccine in an experimental ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.02.031
更新日期:2011-04-18 00:00:00
abstract::We previously developed a dengue tetravalent DNA vaccine that can induce neutralizing antibodies against four dengue viruses in mice. Here, we demonstrated that immunogenicity of our tetravalent vaccine is synergistically increased in mice by co-immunization with dengue type 2 virus (DENV2) subviral extracellular part...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2006.09.059
更新日期:2007-01-22 00:00:00
abstract::In HIV vaccine trials, the collection and analysis of participant behavior data associated with risk of acquiring HIV-infection is important for a number of reasons. Although the rationale for behavioral risk assessment in HIV vaccine clinical trials is clear, consistent collection of behavioral data over time and acr...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2013.07.003
更新日期:2013-09-13 00:00:00
abstract::Pertussis vaccine development has mainly focused on Bordetella pertussis, and consequently these vaccines contain B. pertussis antigens only. However, the related species Bordetella parapertussis can also cause pertussis, although symptoms associated with the disease are generally considered to be milder. Recent field...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2003.11.005
更新日期:2004-05-07 00:00:00
abstract::Experiments were carried out to examine the initial feasibility of immunizing infants and children with inactivated influenza virus vaccine combined with diphtheria-tetanus-pertussis (DTP) vaccine. Groups of mice were immunized with saline vaccine or vaccine mixed with DTP: three doses of vaccine were given 3 weeks ap...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/0264-410x(95)93310-6
更新日期:1995-02-01 00:00:00
abstract::Vaccination of health-care workers (HCWs) against seasonal influenza has been consistently recommended worldwide in order to prevent nosocomial transmission and ensure delivery of health-care services during outbreaks. We describe the effects of a nationwide campaign to promote influenza vaccination among HCWs working...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2010.06.108
更新日期:2010-08-23 00:00:00
abstract:BACKGROUND:Poliomyelitis is endemic in Northern Nigeria where there is continuous transmission of wild poliovirus 1 and 3 (WPV1 and 3) and circulating vaccine derived poliovirus 2 (cVDPV2) resulting in a high number of cases of children with acute flaccid paralysis. The seroprevalence of antibodies to polio serotypes w...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2012.09.023
更新日期:2012-11-06 00:00:00
abstract::We tested a candidate live, oral, rotavirus vaccine (Rotavin-M1™) derived from an attenuated G1P [8] strain (KH0118-2003) isolated from a child in Vietnam. The vaccine was tested first for safety in 29 healthy adults. When deemed safe, it was further tested for safety and immunogenicity in 160 infants (4 groups) aged ...
journal_title:Vaccine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.vaccine.2011.07.118
更新日期:2012-04-27 00:00:00
abstract::Viral vectors are promising vaccine candidates for eliciting suitable Ag-specific immune response. Since Mycobacterium tuberculosis (Mtb) normally enters hosts via the mucosal surface of the lung, the best defense against Mtb is mucosal vaccines that are capable of inducing both systemic and mucosal immunity. Although...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2013.11.108
更新日期:2014-03-26 00:00:00
abstract::A third of the world population is latently infected with Mycobacterium tuberculosis and many cases of active tuberculosis arise from latent bacilli reactivation. Thus, it is important to design new vaccines to prevent reactivation. Using an experimental model of chronic tuberculosis in B6D2F1 mice, we observed consta...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2006.12.042
更新日期:2007-05-04 00:00:00
abstract:BACKGROUND:In 2014 the Kenya National Immunization Technical Advisory Group (KENITAG) was asked by the Ministry of Health to provide an evidence-based recommendation on whether the seasonal influenza vaccine should be introduced into the national immunization program (NIP). METHODS:We reviewed KENITAG manuals, reports...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2018.11.062
更新日期:2019-01-14 00:00:00
abstract::Although studies have described factors associated with pertussis hospitalization in children, data on adult hospitalization are sparse. We examined the association between patient characteristics and hospitalization among older adults with pertussis. We conducted a nested case-control study of participants in the 45 ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2015.08.068
更新日期:2015-10-13 00:00:00
abstract::Yellow fever (YF) is an endemic disease in some tropical areas of South America and Africa that presents lethality rate between 20 and 50%. There is no specific treatment and to control this disease a highly effective live-attenuated egg based vaccine is widely used for travelers and residents of areas where YF is end...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2014.02.036
更新日期:2014-05-19 00:00:00
abstract::We report on 30 in-depth mental models interviews with parents discussing vaccination for their children, both in general terms and in response to communications drawn from sources supporting and opposing vaccines. We found that even parents favourable to vaccination can be confused by the ongoing debate, leading them...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2008.01.011
更新日期:2008-03-17 00:00:00
abstract::In the present study we evaluated Canavalia brasiliensis (ConBr), Pisum arvense (PAA) and Artocarpus integrifolia (KM+) lectins as immunostimulatory molecules in vaccination against Leishmania amazonensis infection. Although they induced IFN-gamma production, the combination of the lectins with SLA antigen did not lea...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2005.11.067
更新日期:2006-04-05 00:00:00
abstract::The objective of this study was to investigate the prevalence of hepatitis B markers in a representative sample of 2142 subjects in Catalonia, Spain, and to compare it with previous studies. Multiple logistical regression analysis was carried out to determine variables associated with the markers studied. The prevalen...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(00)00028-1
更新日期:2000-05-08 00:00:00
abstract::Following routine childhood vaccination against Haemophilus influenzae type b (Hib) disease in Brazil in 1999, passive laboratory surveillance reported increasing numbers of non-b serotypes and nontypeable H. influenzae (NTHi) from meningitis cases. To characterize this increase, we analyzed data on 3910 H. influenzae...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.09.053
更新日期:2011-11-08 00:00:00
abstract::Successful launches of recently licensed vaccines contrast with pharmaceutical industry concerns about unfavorable market conditions, making the status and future of vaccine development uncertain. We assessed trends in private-sector vaccine research and development for the period 1995-2008, using a global pharmaceuti...
journal_title:Vaccine
pub_type: 历史文章,杂志文章,评审
doi:10.1016/j.vaccine.2009.11.007
更新日期:2010-02-03 00:00:00