当前位置： SCI文献检索 > VACCINE期刊下所有文献 > Data management of clinical trials during an outbreak of Ebola virus disease.

Data management of clinical trials during an outbreak of Ebola virus disease.

Abstract：

INTRODUCTION:Clinical trial data management (DM) conducted during outbreaks like that of Ebola virus disease (EVD) in West Africa, 2014-2016, has to adapt to specific, unique circumstances. CTU Bern was asked to set up a safe data capture/management system that could be launched within a few weeks and cover two different vaccine trials. This article describes some of the challenges we faced and our solutions during the two different trials. METHODS:Setting up a DM system was split into four phases/tasks: (1) quick set-up of the (electronic) data capture system (EDC) and mobile infrastructure in Bern, (2) moving the EDC and infrastructure to Conakry, Guinea and implementation of a local data management centre (DMC), (3) running the DMC, and (4) data cleaning. The DMC had to meet the following criteria: (1) quick implementation, (2) efficient maintenance and handling of data, and (3) procedures to guarantee data quality. The EDC (REDCap) was setup as a local area network. In order to ensure high data quality, double data entry, and then review of inconsistencies and offline plausibility checks were implemented. RESULTS:From the start of CTU Bern's involvement to the productive EDC took 11 weeks. It was necessary to adapt processes for dealing with data continuously throughout the trial conduct phase. The data management team processed 171,794 case report form pages from a total of 14,203 participants in the period between March and December 2015. CONCLUSION:Data management is a key task supporting trial conduct. For trials in emergency situations, many of our approaches are suitable, but we also provide a list of aspects that might be done differently.

journal_name

Vaccine

journal_title

Vaccine

authors

Hossmann S,Haynes AG,Spoerri A,Diatta ID,Aboubacar B,Egger M,Rintelen F,Trelle S

doi

10.1016/j.vaccine.2017.09.094

subject

Has Abstract

pub_date

2019-11-15 00:00:00

pages

7183-7189

issue

48

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(17)31367-1

journal_volume

37

pub_type

杂志文章

相关文献

VACCINE文献大全
  • Vaccination coverage against 2009 seasonal influenza in chronically ill children and adults: analysis of population registries in primary care in Madrid (Spain).

    abstract：:Using electronic clinical records in primary care (ECRPC) of the entire population living in the Autonomous Community of Madrid, Spain (5,102,568 persons) as a data source, this study aimed to ascertain seasonal anti-influenza vaccination coverage in the chronically ill at-risk children (aged 6 months to 14 years) and...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2010.07.013

    authors： Rodríguez-Rieiro C,Domínguez-Berjón MF,Esteban-Vasallo MD,Sánchez-Perruca L,Astray-Mochales J,Fornies DI,Ordoñez DB,Jiménez-García R

    更新日期：2010-08-31 00:00:00

  • Rabies post-exposure prophylaxis vaccination with purified chick embryo cell vaccine (PCECV) and purified Vero cell rabies vaccine (PVRV) in a four-site intradermal schedule (4-0-2-0-1-1): an immunogenic, cost-effective and practical regimen.

    abstract：:Currently, two intradermal (ID) regimens for rabies post-exposure prophylaxis (PEP) are recommended by WHO and used in countries where approved by national authorities: the Thai Red Cross (TRC) two-site ID regimen and the eight-site ID regimen. Besides these WHO recommended schedules, a new economical four-site ID reg...

    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.2006.02.036

    authors： Ambrozaitis A,Laiskonis A,Balciuniene L,Banzhoff A,Malerczyk C

    更新日期：2006-05-08 00:00:00

  • Human IgG subclass responses in relation to serum bactericidal and opsonic activities after immunization with three doses of the Norwegian serogroup B meningococcal outer membrane vesicle vaccine.

    abstract：:Ten adult volunteers, with low prevaccination levels of serum IgG antibodies against meningococcal antigens (< 1 microg ml(-1)), received three doses of the Norwegian group B meningococcal outer membrane vesicle (OMV) vaccine intramuscularly at weeks 0, 6 and 46. Anti-OMV IgG subclass responses were measured and compa...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/s0264-410x(98)00259-x

    authors： Naess LM,Aarvak T,Aase A,Oftung F,Høiby EA,Sandin R,Michaelsen TE

    更新日期：1999-02-26 00:00:00

  • The recombinant Lactococcus lactis oral vaccine induces protection against C. difficile spore challenge in a mouse model.

    abstract：:Clostridium difficile infection (CDI) causes nosocomial antibiotic-associated diarrhea and colitis in the developed world. Two potent cytotoxins, toxin A (TcdA) and toxin B (TcdB) are the virulence factors of this disease and can be a good vaccine candidate against CDI. In the present study, we genetically engineered ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2015.02.006

    authors： Guo S,Yan W,McDonough SP,Lin N,Wu KJ,He H,Xiang H,Yang M,Moreira MA,Chang YF

    更新日期：2015-03-24 00:00:00

  • Potential of a sequence-based antigenic distance measure to indicate equine influenza vaccine strain efficacy.

    abstract：:The calculation of p(epitope) values, a sequence-based measure of antigenic distance between strains, was developed for human influenza. The potential to apply the p(epitope) value to equine influenza vaccine strain selection was assessed. There was a negative correlation between p(epitope) value and vaccine efficacy ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2013.06.070

    authors： Daly JM,Elton D

    更新日期：2013-12-09 00:00:00

  • Human lactoferrin proteolytic activity: analysis of the cleaved region in the IgA protease of Haemophilus influenzae.

    abstract：:Human lactoferrin proteolytically cleaves and inactivates two colonization factors of non-typable Haemophilus influenzae, the IgA protease precursor protein (Iga), and Hap, the non-pilus adhesin by which microoganisms adhere to host epithelial cells and form microcolonies. Iga and Hap are homologous proteins that are ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/s0264-410x(00)00296-6

    authors： Plaut AG,Qiu J,St Geme JW 3rd

    更新日期：2000-12-08 00:00:00

  • Manipulation of neuraminidase packaging signals and hemagglutinin residues improves the growth of A/Anhui/1/2013 (H7N9) influenza vaccine virus yield in eggs.

    abstract：:In 2013, a novel avian-origin H7N9 influenza A virus causing severe lower respiratory tract disease in humans emerged in China, with continued sporadic cases. An effective vaccine is needed for this virus in case it acquires transmissibility among humans; however, PR8-based A/Anhui/1/2013 (Anhui/1, H7N9), a WHO-recomm...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2017.01.061

    authors： Barman S,Krylov PS,Turner JC,Franks J,Webster RG,Husain M,Webby RJ

    更新日期：2017-03-07 00:00:00

  • National surveillance of invasive pneumococcal diseases in Taiwan, 2008-2012: differential temporal emergence of serotype 19A.

    abstract：INTRODUCTION:Serotype replacement after the introduction of seven-valent pneumococcal conjugate vaccine (PCV7) and the future availability of multivalent PCVs prompted the listing of invasive pneumococcal disease (IPD) as a notifiable disease in Taiwan in October 2007. Here, we report the national surveillance results....

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2014.04.061

    authors： Chiang CS,Chen YY,Jiang SF,Liu DP,Kao PH,Teng HJ,Kuo TL,Yao SM,Tseng LR,Wang YL,Wu HS,Chang FY,Lin TY

    更新日期：2014-06-05 00:00:00

  • Evaluation of modified vaccinia virus Ankara based recombinant SARS vaccine in ferrets.

    abstract：:Severe acute respiratory syndrome (SARS) caused by a newly identified coronavirus (SARS-CoV) remains a threat to cause epidemics as evidenced by recent sporadic cases in China. In this communication, we evaluated the efficacy and safety of two SARS vaccine candidates based on the recombinant modified vaccinia Ankara (...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2005.01.033

    authors： Czub M,Weingartl H,Czub S,He R,Cao J

    更新日期：2005-03-18 00:00:00

  • Induction of anti-viral immune responses by immunization with recombinant-DNA encoded avian coronavirus nucleocapsid protein.

    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

    authors： Boots AM,Benaissa-Trouw BJ,Hesselink W,Rijke E,Schrier C,Hensen EJ

    更新日期：1992-01-01 00:00:00

  • Cross-reactive neutralizing antibody epitopes against Enterovirus 71 identified by an in silico approach.

    abstract：:Currently, infections of hand, foot and mouth disease (HFMD) due to Human Enterovirus 71 (EV71) cannot be prevented or treated, as there are no suitable vaccines or antiviral drugs. This study aimed to identify potential vaccine candidates for EV71 using in silico analysis of its viral capsid proteins. A combined in s...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2012.09.030

    authors： Kirk K,Poh CL,Fecondo J,Pourianfar H,Shaw J,Grollo L

    更新日期：2012-11-19 00:00:00

  • Archaeal glycolipid adjuvanted vaccines induce strong influenza-specific immune responses through direct immunization in young and aged mice or through passive maternal immunization.

    abstract：:Vaccine induced responses are often weaker in those individuals most susceptible to infection, namely the very young and the elderly, highlighting the need for safe and effective vaccine adjuvants. Herein we evaluated different archaeosome formulations as an adjuvant to the H1N1 influenza hemagglutinin protein and com...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2019.07.010

    authors： Stark FC,Akache B,Ponce A,Dudani R,Deschatelets L,Jia Y,Sauvageau J,Williams D,Jamshidi MP,Agbayani G,Wachholz K,Harrison BA,Li X,Krishnan L,Chen W,McCluskie MJ

    更新日期：2019-11-08 00:00:00

  • Nef modulates the immunogenicity of Gag encoded in a non-infectious HIV DNA vaccine.

    abstract：:Gag-CD8+ T cell responses are associated with immune control of HIV infection. Since during HIV infection Nef impairs T cell responses, we evaluated whether deletion of nef from a non-infectious HIV DNA vaccine (Delta4 Nef+), creating Delta5 Nef(-), would affect its immunogenicity. When compared with Delta4, mice inje...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2008.05.057

    authors： Arrode G,Hegde R,Jin Y,Singh DK,Narayan O,Chebloune Y

    更新日期：2008-07-23 00:00:00

  • Effectiveness of a novel immunogenic nanoparticle platform for Toxoplasma peptide vaccine in HLA transgenic mice.

    abstract：:We created and produced a novel self-assembling nanoparticle platform for delivery of peptide epitopes that induces CD8(+) and CD4(+)T cells that are protective against Toxoplasma gondii infection. These self-assembling polypeptide nanoparticles (SAPNs) are composed of linear peptide (LP) monomers which contain two co...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2014.03.092

    authors： El Bissati K,Zhou Y,Dasgupta D,Cobb D,Dubey JP,Burkhard P,Lanar DE,McLeod R

    更新日期：2014-05-30 00:00:00

  • CCL5-independent helper T lymphocyte responses to immuno-dominant pneumococcal surface protein A epitopes.

    abstract：:Understanding the requirements for protection against pneumococcal carriage and pneumonia will greatly benefit efforts in controlling these diseases. Several antigens, in addition to the polysaccharide capsule, have been implicated in both the virulence and protective immunity against Streptococcus pneumoniae; one of ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2011.12.020

    authors： Singh R,Singh S,Briles DE,Taub DD,Hollingshead SK,Lillard JW Jr

    更新日期：2012-02-01 00:00:00

  • The association of ethnicity with antibody responses to pneumococcal vaccination among adults with HIV infection.

    abstract：:Ethnicity may be associated with the incidence of pneumococcal infections and the frequency of protective vaccine responses. Earlier studies have suggested that HIV-infected persons of black ethnicity develop less robust immune responses to pneumococcal vaccination that may relate to their higher incidence of invasive...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2010.09.056

    authors： Crum-Cianflone NF,Roediger M,Huppler Hullsiek K,Ganesan A,Landrum M,Weintrob A,Agan B,Medina S,Rahkola J,Hale B,Janoff EN,Infectious Disease Clinical Research Program HIV Working Group.

    更新日期：2010-11-10 00:00:00

  • Overview of cervical cancer screening practices in the extended Middle East and North Africa countries.

    abstract：:National Organized Cervical Cancer Screening (NOCCS) programs are lacking in most of the "Extended Middle East and North Africa" (EMENA) countries. Consequently, most cervical cancers are diagnosed late and are associated with high mortality. In fact, in most of these countries, national mortality data are unknown due...

    journal_title：Vaccine

    pub_type： 杂志文章,评审

    doi：10.1016/j.vaccine.2012.06.046

    authors： Sancho-Garnier H,Khazraji YC,Cherif MH,Mahnane A,Hsairi M,El Shalakamy A,Osgul N,Tuncer M,Jumaan AO,Seoud M

    更新日期：2013-12-30 00:00:00

  • Synthetic luteinizing hormone releasing hormone (LHRH) vaccine for effective androgen deprivation and its application to prostate cancer immunotherapy.

    abstract：:We have designed a peptide-based immunotherapeutic vaccine for treatment of androgen-responsive prostate cancer. The vaccine targets the luteinizing hormone-releasing hormone (LHRH) decapeptide that results in an androgen-deprivation immunotherapy. The design elements of the peptide immunogens are the LHRH peptide or ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2003.08.044

    authors： Finstad CL,Wang CY,Kowalski J,Zhang M,Li ML,Li XM,Xia WG,Bosland MC,Murthy KK,Walfield AM,Koff WC,Zamb TJ

    更新日期：2004-03-12 00:00:00

  • Influenza vaccine effectiveness in preventing influenza-associated intensive care admissions and attenuating severe disease among adults in New Zealand 2012-2015.

    abstract：BACKGROUND:Little is known about inactivated influenza vaccine effectiveness (IVE) in preventing very severe disease, including influenza-associated intensive care unit (ICU) admissions. METHODS:The Southern Hemisphere Influenza and Vaccine Effectiveness Research and Surveillance (SHIVERS) project enrolled adults (age...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2018.07.028

    authors： Thompson MG,Pierse N,Sue Huang Q,Prasad N,Duque J,Claire Newbern E,Baker MG,Turner N,McArthur C,SHIVERS investigation team.

    更新日期：2018-09-18 00:00:00

  • Evaluation of hyaluronic acid-based combination adjuvant containing monophosphoryl lipid A and aluminum salt for hepatitis B vaccine.

    abstract：:Here, monophosphoryl lipid A (MPLA) and aluminum salt (Alum) were introduced into a hyaluronic acid (HA)-based combination vaccine adjuvant for hepatitis B vaccine (HBV). Although Alum is a well-known hepatitis B vaccine adjuvant that induces an enhanced humoral immune response, it cannot induce the cellular immune re...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2015.08.006

    authors： Moon SH,Shin EC,Noh YW,Lim YT

    更新日期：2015-09-11 00:00:00

  • Knowledge of human papillomavirus (HPV) and HPV vaccination: an international comparison.

    abstract：:Since vaccination against human papillomavirus (HPV) became available, awareness of HPV has dramatically increased. Implementation of a vaccine program varies internationally yet no studies have explored the influence this has on the public's knowledge of HPV. The present study aimed to explore differences in awarenes...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2012.11.083

    authors： Marlow LA,Zimet GD,McCaffery KJ,Ostini R,Waller J

    更新日期：2013-01-21 00:00:00

  • Avipox-based simian immunodeficiency virus (SIV) vaccines elicit a high frequency of SIV-specific CD4+ and CD8+ T-cell responses in vaccinia-experienced SIVmac251-infected macaques.

    abstract：:The ability of ALVAC- or fowlpox-based simian immunodeficiency virus (SIV) vaccines to boost SIV-specific CD4+ and CD8+ T-cell responses was tested in 10 vaccinia-experienced macaques infected with SIVmac251. The CD8+ T-cell response to the dominant Gag(181-189) CM9 was quantitated in seven Mamu-A*01-positive macaques...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2003.08.028

    authors： Nacsa J,Radaelli A,Edghill-Smith Y,Venzon D,Tsai WP,Morghen Cde G,Panicali D,Tartaglia J,Franchini G

    更新日期：2004-01-26 00:00:00

  • Comparison of prophylactic and therapeutic immunisation with an ErbB-2 (HER2) fusion protein and immunoglobulin V-gene repertoire analysis in a transgenic mouse model of spontaneous breast cancer.

    abstract：:ErbB-2 is associated with several solid tumours of which breast cancer is the commonest cancer in women worldwide. Though anti-ErbB-2 antibody appears to play a significant role in prevention and therapy, naturally occurring anti-ErbB-2 antibody associated with the cleaved ectodomain of overexpressed ErbB-2 self antig...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2013.10.077

    authors： Mukhopadhyay A,Dyring C,Stott DI

    更新日期：2014-02-12 00:00:00

  • Novel vaccine concept based on back-boost effect in viral infection.

    abstract：:A novel vaccine concept is discussed based on recent evidence of a "back-boost" effect in Influenza infection. The initial immune response to the infection is imprinted through an immune memory pathway. The immune memory in the back-boost mechanism could be used in reversed order as a "forward-boost" in the proposed v...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2015.05.035

    authors： Kohler H

    更新日期：2015-06-26 00:00:00

  • Effective adjuvants for the induction of antigen-specific delayed-type hypersensitivity.

    abstract：:Vaccines utilizing poorly immunogenic subunit antigens are dependent upon adjuvants to drive the appropriate T cell responses. In an effort to determine the ability of several adjuvants to promote cell-mediated immunity (CMI), we assessed delayed-type hypersensitivity (DTH) in mice inoculated with heat-killed Listeria...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/s0264-410x(96)00199-5

    authors： Baldridge JR,Ward JR

    更新日期：1997-03-01 00:00:00

  • The immunoglobulin M-degrading enzyme of Streptococcus suis, IdeSsuis, is a highly protective antigen against serotype 2.

    abstract：:Streptococcus suis (S. suis) is a major porcine pathogen causing meningitis, arthritis and several other pathologies. Recently, we identified a highly specific immunoglobulin M degrading enzyme of S. suis, designated IdeSsuis, which is expressed by various serotypes. The objective of this work was to access the immuno...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2015.03.047

    authors： Seele J,Hillermann LM,Beineke A,Seitz M,von Pawel-Rammingen U,Valentin-Weigand P,Baums CG

    更新日期：2015-05-05 00:00:00

  • Haemophilus influenzae meningitis 5 years after introduction of the Haemophilus influenzae type b conjugate vaccine in Brazil.

    abstract：:The long-term impact of Haemophilus influenzae type b (Hib) conjugate vaccine, introduced throughout Latin America in the late 1990s, has not been evaluated. Active surveillance for H. influenzae meningitis was performed from August 9, 1996 to August 8, 2004 in Metropolitan Salvador, Brazil. Five years after the intro...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2007.03.024

    authors： Ribeiro GS,Lima JB,Reis JN,Gouveia EL,Cordeiro SM,Lobo TS,Pinheiro RM,Ribeiro CT,Neves AB,Salgado K,Silva HR,Reis MG,Ko AI

    更新日期：2007-05-30 00:00:00

  • Immunisation with proteins expressed during chronic murine melioidosis provides enhanced protection against disease.

    abstract：:There is an urgent need for an effective vaccine against human disease caused by Burkholderia pseudomallei, and although a wide range of candidates have been tested in mice none provide high level protection. We considered this might reflect the inability of these vaccine candidates to protect against chronic disease....

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2016.02.038

    authors： Champion OL,Gourlay LJ,Scott AE,Lassaux P,Conejero L,Perletti L,Hemsley C,Prior J,Bancroft G,Bolognesi M,Titball RW

    更新日期：2016-03-29 00:00:00

  • Establishment of gene-vaccinated skin grafting against Toxoplasma gondii infection in mice.

    abstract：:Vaccine effects of in vivo gene-vaccinated skin graft were evaluated against Toxoplasma gondii (T. gondii) infection. By using a gene gun, cDNA coding T. gondii SAG1 molecule was intracutaneously vaccinated into C57BL/6 (B6; a susceptible strain), BALB/c (a resistant strain) and (C57BL/6 x BALB/c) F1 (CBF1) mice, and ...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/s0264-410x(00)00366-2

    authors： Saito S,Aosai F,Rikihisa N,Mun HS,Norose K,Chen M,Kuroki T,Asano T,Ochiai T,Hata H,Ichinose M,Yano A

    更新日期：2001-02-28 00:00:00

  • Infectious bursal disease virus rescued efficiently with 3' authentic RNA sequence induces humoral immunity without bursal atrophy.

    abstract：:A reverse genetics infectious bursal disease virus (RG-IBDV) that contained authentic 3' RNA sequence was characterized both in vitro and in vivo. LP1-IBDV, a cell line-adapted IBDV strain variant E (VE) was used as the parent virus for constructing viral cDNA clones. Authentic 3' RNA sequence was generated by using c...

    journal_title：Vaccine

    pub_type： 杂志文章

    doi：10.1016/j.vaccine.2012.11.040

    authors： Mosley YY,Wu CC,Lin TL

    更新日期：2013-01-11 00:00:00