Abstract：
:Randomized controlled clinical trials represent the best way to establish the therapeutic or preventive value of medicines. This decade has seen a strong shift in the location of clinical trials from industrialized countries to developing countries, including many in Africa. However, without independent strong regulatory and ethical oversight of clinical trials the safety of research subjects, and scientific integrity of clinical data cannot be verified. This article draws up a portrait of clinical trials regulation in Africa in support of development of priority medicines, highlights challenges and presents the progress made by countries under WHO guidance over the past 5 years.
journal_name
Vaccinejournal_title
Vaccineauthors
Maïga D,Akanmori BD,Chocarro Ldoi
10.1016/j.vaccine.2009.08.113subject
Has Abstractpub_date
2009-12-09 00:00:00pages
7249-52issue
52eissn
0264-410Xissn
1873-2518pii
S0264-410X(09)01324-3journal_volume
27pub_type
杂志文章相关文献
VACCINE文献大全abstract：:DNA vaccination with plasmid has conventionally involved vectors designed for transient expression of antigens in injected tissues. Next generation plasmids are being developed for site-directed integration of transgenes into safe sites in host genomes and may provide an innovative approach for stable and sustained ex...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2014.01.063
更新日期：2014-03-26 00:00:00
abstract：:Effective antigen delivery is one of the most important issues in vaccine development. It has been suggested that adjuvant action results from a depot effect by prolonging the duration of the interaction between antigen and cells, and thus is related to the antigen-releasing properties of emulsion adjuvants. The objec...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2004.09.007
更新日期：2005-04-08 00:00:00
abstract：:Rams which were vaccinated at 6-8 months of age with a water-in-oil Brucella ovis-vitamin E adjuvant vaccine had significantly higher serum antibody levels than rams vaccinated with a commercial B. ovis bacterin or B. melitensis Rev 1. The adjuvant vaccine did not cause abscesses at the site of injection as some water...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/0264-410x(91)90111-i
更新日期：1991-04-01 00:00:00
abstract：:Few suspension cells can be used for vaccine manufacturing today as they either do not meet requirements from health regulatory authorities or do not produce high virus titres. Two new avian designer cell lines (AGE1.CR and AGE1.CR.pIX) that have been adapted to grow in suspension in serum-free medium were evaluated f...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2009.05.083
更新日期：2009-08-06 00:00:00
abstract：:Because of delays in the manufacturing of the 2000-2001, trivalent inactivated influenza vaccine in the US, there were concerns that there might be shortages of vaccine supply in the US. Therefore, we conducted a prospective, randomized, open-label, multicenter trial at six academic medical centers in the US, to evalu...
journal_title：Vaccine
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0264-410x(01)00440-6
更新日期：2002-01-15 00:00:00
abstract：:This study compared responses of bison calves to 10(10)CFU of Brucella abortus strain RB51 (SRB51) delivered by parenteral or ballistic methods. Two types of biobullet payloads were evaluated; compacted SRB51 pellets or SRB51 encapsulated in photopolymerized poly(ethylene glycol) hydrogels. Bison were vaccinated with ...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2005.09.034
更新日期：2006-02-27 00:00:00
abstract：:HPV vaccination schedules have changed as evidence has supported reduced dosing and extended intervals. Women living with HIV (WLWH) represent an important population with no data on alternative dosing. Girls and WLWH received quadrivalent HPV (qHPV) vaccine in a pan-Canadian study of immunogenicity and efficacy. Sero...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2020.02.075
更新日期：2020-03-30 00:00:00
abstract：:The ability to protect mice against respiratory infections with virulent Francisella tularensis has been problematic and the role of antibody-versus-cell-mediated immunity controversial. In this study, we tested the hypothesis that protective immunity can develop in mice that were given antibiotic therapy following in...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2008.09.077
更新日期：2008-12-09 00:00:00
abstract：:Neutralizing antibodies play an essential part in antiviral immunity and are instrumental in preventing or modulating viral diseases. Polyclonal antibody preparations are increasingly being replaced by highly potent monoclonal antibodies (mAbs). Cocktails of mAbs and bispecific constructs can be used to simultaneously...
journal_title：Vaccine
pub_type： 杂志文章,评审
doi：10.1016/j.vaccine.2013.01.025
更新日期：2013-03-15 00:00:00
abstract：BACKGROUND:The burden of influenza is increasingly recognised in Africa. The WHO recommends introducing influenza vaccination to high-risk groups: pregnant women, children <5 years, and the elderly. The Gambia currently has no influenza vaccination policy, but the NASIMMUNE study, a clinical trial of intranasal live at...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2018.02.037
更新日期：2018-03-20 00:00:00
abstract：:The aim of this study was to estimate the effectiveness of 2009 seasonal trivalent inactivated vaccine in reducing hospitalizations due to the novel influenza A H1N1 virus among positive cases. Data collected from Argentina's national epidemiological surveillance system were analyzed. All patients had a clinical diagn...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2010.05.051
更新日期：2010-07-19 00:00:00
abstract：:The effects of beta-propiolactone (BPL), an alkylating and virus inactivating agent, on the structural and in vitro biological properties of different DNA preparations from BHK-21 cells were investigated. Both uninfected and rabies virus-infected cells were used. Purified cellular DNA (celDNA) was used as the referenc...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/0264-410x(93)90343-v
更新日期：1993-01-01 00:00:00
abstract：:A DNA vaccine codifying the mycobacterial hsp65 can prevent infection with Mycobacterium tuberculosis in a prophylactic setting and also therapeutically reduce the number of bacteria in infected mice. The protective mechanism is thought to be related to Th1-mediated events that result in bacterial killing. To determin...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/s0264-410x(03)00543-7
更新日期：2003-12-08 00:00:00
abstract：:We have recently developed a transmissible vaccine to immunize rabbits against myxomatosis and rabbit haemorrhagic disease based on a recombinant myxoma virus (MV) expressing the rabbit haemorrhagic disease virus (RHDV) capsid protein [Bárcena et al. Horizontal transmissible protection against myxomatosis and rabbit h...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/s0264-410x(00)00183-3
更新日期：2000-09-15 00:00:00
abstract：:We have recently demonstrated that the novel glycoalkaloid tomatine, derived from leaves of the wild tomato Lycopersicon pimpinellifolium, can act as a powerful adjuvant for the elicitation of antigen-specific CD8+ T cell responses. Here, we have extended our previous investigation with the model antigen ovalbumin to ...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/s0264-410x(01)00166-9
更新日期：2001-07-20 00:00:00
abstract：:A soluble fraction obtained from Bordetella pertussis was evaluated as adjuvant for the pertussis component of the Diphtheria-Pertussis-Tetanus (DPT) vaccine. High levels of antibodies were induced, and a 78% protection rate of mice challenged with live B. pertussis was observed. Two proteins were identified as the 73...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2006.08.033
更新日期：2007-01-08 00:00:00
abstract：:The 23-valent pneumococcal vaccine has unequal effectiveness in splenectomised patients. We performed a longitudinal study (2005-2008) whose main objective was to characterize the profile of non-responders among splenectomised patients treated at our institution and identify potential predictive indicators of the resp...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2011.09.073
更新日期：2012-03-16 00:00:00
abstract：:Immunological memory induced by nasal immunization with adjuvant-combined influenza vaccine was analyzed in different ages and strains of mice. The memory activities were assessed by secondary nasal-wash IgA and serum IgG antibody (Ab) responses and protection against challenge infection with a lethal dose of influenz...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2007.06.060
更新日期：2007-09-28 00:00:00
abstract：BACKGROUND:The effectiveness of inactivated influenza vaccine (IIV) immunization in preventing all cause respiratory illness (RI) in children with pre-existing medical conditions has not been fully established and varies from season to season. This study aims to quantify the overall impact of IIV immunization on primar...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2019.11.086
更新日期：2020-04-09 00:00:00
abstract：:Flagellin of Pseudomonas aeruginosa is an important vaccine candidate. N-terminal domains are highly conserved in both type a and type b flagellins. The efficacy of gold nanoparticles (AuNPs) conjugated to N-terminal domains of P. aeruginosa flagellin (flagellin(1-161)), as an immunogen in mice, has been assessed. The...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2016.01.041
更新日期：2016-03-14 00:00:00
abstract：BACKGROUND:Racial differences have been observed in the rate of bacterial infection and disease progression in HIV. Here, we evaluate racial differences in seasonal influenza vaccine responses. METHODS:16 healthy controls (9 Caucasians (CC) and 7 African Americans (AA)) and 26 antiretroviral therapy (ART)-treated avir...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2020.01.002
更新日期：2020-02-18 00:00:00
abstract：:Codon-pair bias de-optimization (CPBD) of viruses involves re-writing viral genes using statistically underrepresented codon pairs, without any changes to the amino acid sequence or codon usage. Previously, this technology has been used to attenuate the influenza A/Puerto Rico/8/34 (H1N1) virus. The de-optimized virus...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2015.11.054
更新日期：2016-01-20 00:00:00
abstract：:Prior to routine immunisation, Haemophilus influenzae serotype b (Hib) was a major cause of serious bacterial infections, particularly in young children. In the United Kingdom, introduction of the Hib conjugate vaccine into the national childhood immunisation schedule has led to a sustained decline in invasive Hib dis...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2014.08.010
更新日期：2014-09-29 00:00:00
abstract：:The stockpiling of live vaccinia virus vaccines has enhanced biopreparedness against the intentional or accidental release of smallpox. Ongoing research on future generation smallpox vaccines is providing key insights into protective immune responses as well as important information about subunit-vaccine design strate...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2012.11.007
更新日期：2013-01-02 00:00:00
abstract：:Seneca Valley virus (SVV) infection in pigs is associated with porcine idiopathic vesicular disease (PIVD). Outbreaks of SVV infection in pig herds have been reported in several Asia and Americas countries. Recently, a series of outbreaks of SVV infection occurred in China, Canada, Thailand and the United States. Howe...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2017.12.055
更新日期：2018-02-01 00:00:00
abstract：:Patterns of microRNA expression appear to delineate the process of spontaneous neoplastic development-transformation (SPNDT) occurring in the African green monkey kidney (AGMK) VERO cell line (Teferedegne et al., 2010). Analysis of microarray data identified 6 microRNAs whose high-level of expression peaked when the W...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/j.vaccine.2017.04.004
更新日期：2017-10-04 00:00:00
abstract：:The immunopotentiating activities of colloidal iron hydroxide, a novel, experimental mineral adjuvant, and of aluminium hydroxide. the licensed adjuvant for human vaccines, were compared. Our studies revealed that colloidal iron hydroxide and aluminium hydroxide behaved comparably with respect to supporting induction ...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/s0264-410x(98)00201-1
更新日期：1999-03-05 00:00:00
abstract：:T lymphocytes play a central role in the generation of a protective immune response in many microbial infections. After immunization, dendritic cells take up microbial antigens and traffic to draining lymph nodes where they present processed antigens to naïve T cells. These naïve T cells are stimulated to proliferate ...
journal_title：Vaccine
pub_type： 杂志文章,评审
doi：10.1016/s0264-410x(02)00407-3
更新日期：2003-01-17 00:00:00
abstract：:A randomized, double-blind trial comparing a diphtheria-tetanus-acellular pertussis vaccine (DTaP) (pertussis toxoid and filamentous hemagglutinin) with a whole-cell vaccine (DTwP) was conducted. A case-contact study was nested in the trial to estimate absolute efficacy. From 1990 through 1994, 4181 children were rand...
journal_title：Vaccine
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0264-410x(97)00100-x
更新日期：1997-10-01 00:00:00
abstract：:One hundred and fourteen children, born to HBsAg-positive mothers received in the first year of life passive active prophylaxis for hepatitis B virus (HBV). They have been followed up to 10 years. A booster dose given in a cohort at the 5th year does not seem to increase protection against HBV. No difference in immuno...
journal_title：Vaccine
pub_type： 杂志文章
doi：10.1016/s0264-410x(97)00028-5
更新日期：1997-08-01 00:00:00
