Abstract:
:In this paper we give guidance for the design and conduct of vaccine trials against Plasmodium vivax malaria. The paper supplements earlier guidelines on the planning of vaccine trials against Plasmodium falciparum malaria [WHO. Guidelines for the evaluation of Plasmodium falciparum vaccines in populations exposed to natural infections. Geneva: World Health Organization; 1997, http://www.who.int/vaccine_research/feuill_1_4-2.pdf], with further considerations in two later documents [Moorthy VS, Reed Z, Smith PG. Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation. Vaccine 2007 July 9;25(28):5115-23; Moorthy V, Reed Z, Smith P. MALVAC 2008: measures of efficacy of malaria vaccines in phase 2b and phase 3 trials - scientific, regulatory and public health perspectives. Vaccine 2009 January 29;27(5):624-8]. We deal specifically with study design and methodological issues for the assessment of pre-erythrocytic and blood-stage vaccines against P. vivax. The role of vaccines in blocking transmission of P. vivax is not considered as the methodological issues are similar to those for P. falciparum, though longer follow-up would be required because of the potential for relapse discussed below. In this paper we discuss the rationale and background to trials of P. vivax vaccines, requirements for Phase IIb and Phase III field trials, implementation of clinical trials, methods of measurement and analysis, and ethical aspects.
journal_name
Vaccinejournal_title
Vaccineauthors
Mueller I,Moorthy VS,Brown GV,Smith PG,Alonso P,Genton B,WHO Malaria Vaccine Advisory Committee (MALVAC).doi
10.1016/j.vaccine.2009.07.018subject
Has Abstractpub_date
2009-09-18 00:00:00pages
5633-43issue
41eissn
0264-410Xissn
1873-2518pii
S0264-410X(09)01030-5journal_volume
27pub_type
杂志文章,实务指引,评审相关文献
VACCINE文献大全abstract::Vaccine adjuvants are essential for enhancing immune responses during vaccination. However, only a limited number of safe and effective adjuvants, especially mucosal adjuvants, are available for use in vaccines. The development of a practically applicable mucosal adjuvant is therefore urgently needed. Here, we showed ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2018.05.075
更新日期:2018-07-05 00:00:00
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
更新日期:2014-02-12 00:00:00
abstract::Schistosomiasis is an important parasitic disease for which there is no available vaccine. We have focused on a functionally important antigen of Schistosoma mansoni, Sm-p80, as a vaccine candidate because of its consistent immunogenicity, protective potential and antifecundity effect observed in murine models; and fo...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.02.096
更新日期:2009-05-11 00:00:00
abstract::The challenges of the journey from target identification through development of a prophylactic quadrivalent human papillomavirus (HPV) vaccine have been met in Gardasil. Cervical cancer is the second leading cause of cancer-related death in women worldwide. Approximately 70% of cervical cancer is caused by infection w...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2007.01.013
更新日期:2007-04-20 00:00:00
abstract::The aim of this work was to evaluate the microencapsulation by spray-drying of inactivated Vibrio cholerae, using methacrylic copolymers Eudragit® L30D-55 and FS30D. The microparticles obtained presented a particle size around 3.0 μm. The preparation temperature affected the morphology and the antigenicity of micropar...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.05.098
更新日期:2011-08-05 00:00:00
abstract:OBJECTIVE:This case-control study investigated the relationship between the risk of Autism Spectrum Disorder (ASD) onset, and early exposure to the combined Measles-Mumps-Rubella (MMR) vaccine and thimerosal consumption measured from vaccinations in the highly genetically homogenous Japanese population. METHODS:Vaccin...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2014.12.036
更新日期:2015-05-15 00:00:00
abstract::The aim of this study was to determine whether an observed increase in non-vaccine-type human papillomavirus (HPV) in unvaccinated women during the first eight years after vaccine introduction may be explained by differences in demographics or sexual behaviors, instead of type replacement. We analyzed data from three ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2017.11.005
更新日期:2017-12-19 00:00:00
abstract::Measles vaccine is widely used, most often in association with mumps and rubella vaccines. We report here the case of a child presenting with fever 8 days after vaccination with a measles-mumps-rubella vaccine. Measles virus was isolated in a throat swab taken 4 days after fever onset. This virus was then further gene...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(01)00495-9
更新日期:2002-02-22 00:00:00
abstract::The objective of this study was to evaluate the validity of information reported by the elderly on 23-valent pneumococcal polysaccharide vaccine (23vPPV) vaccination status. A cross-sectional, observational study was carried out in patients aged >or=65 years admitted to five Spanish hospitals. Data on 23vPPV vaccinati...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.05.057
更新日期:2009-07-23 00:00:00
abstract::A substantial rise in the number of AIDS cases has been observed during the past year in many African countries, and HIV-2 indigenous transmission and increased disease have since gained importance in Senegal. Both for HIV-1 and HIV-2 diagnosis, ELISA positivity is followed by a Western blot test for specific antibodi...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/0264-410x(88)90210-1
更新日期:1988-06-01 00:00:00
abstract::This paper seeks to give some preliminary evidence on the potential outcome of the pneumococcal vaccine Advance Market Commitment (AMC), with a focus on its impact on innovation in 'emerging' vaccine manufacturers in developing countries. The evidence is derived from a series of interviews with executives at industria...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2012.01.046
更新日期:2012-03-23 00:00:00
abstract::The immunity levels against diphtheria, tetanus and poliomyelitis were investigated among blood donors (n = 2079) in Berlin. Of all participants, only 60% had full, long-term protection against diphtheria, 72% against tetanus, 87% against poliomyelitis type 1, 77% against poliomyelitis type 2 and 73% against type 3. T...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(98)00269-2
更新日期:1999-02-26 00:00:00
abstract::Hepatitis B virus (HBV) infection and HBV-associated diseases are prevalent in many parts of the Middle East and North Africa. Postnatal horizontal childhood transmission appears to be the predominant method by which high hepatitis B carrier rates are maintained. To control hepatitis B in this region, mass immunizatio...
journal_title:Vaccine
pub_type: 杂志文章
doi:
更新日期:1990-03-01 00:00:00
abstract::Hepatitis A and B are common infections worldwide and their severity is related to the individual's age upon initial infection. Furthermore, when hepatitis B infection occurs in infants, the risk of becoming a chronic carrier is 90%. For hepatitis A, the lower incidence of disease arising from an improvement in living...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/s0264-410x(00)00464-3
更新日期:2001-03-21 00:00:00
abstract::A new microparticulate delivery system composed of a stabilizing gelatin/poloxamer microcore surrounded by a PLGA coat was designed to improve the stability of tetanus toxoid (TT) encapsulated in PLGA microspheres. Microcores were prepared by a spray-congealing technique and encapsulated within PLGA using an oil-in-oi...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(99)00313-8
更新日期:1999-11-12 00:00:00
abstract::Glycoconjugate vaccines have been proven safe and effective against various diseases in children. Although these vaccines have a history of effectiveness, there are still many unanswered questions to be addressed, including conjugate interference when multiple vaccines are administered at one time, expansion of seroty...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2010.04.072
更新日期:2010-06-17 00:00:00
abstract:OBJECTIVES:To assess the effectiveness and cost-effectiveness of routine childhood vaccination by new vaccines against rotavirus in France. METHODS:We constructed a Markov decision tree to compare two alternatives: "no vaccination" and "vaccination". A hypothetical birth cohort of 750,000 children was followed until 3...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2007.11.064
更新日期:2008-01-30 00:00:00
abstract::We evaluated the prevalence and concentration of serum antibodies 18-24 months after primary inoculation with anthrax and botulinum vaccines, and assessed the reactogenicity and immunogenicity of a significantly delayed booster dose of these vaccines. Five hundred and eight male active-duty military personnel received...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(02)00058-0
更新日期:2002-05-15 00:00:00
abstract::In this review we aim to provide the reader with an understanding of the capsular-based complexity of Streptococcus pneumoniae, one of the main limitations to current vaccine development. We then discuss the need for a new vaccine strategy based on proteic antigen candidates discovered in silico. Describing specifical...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2007.01.065
更新日期:2007-04-20 00:00:00
abstract::Immunization by convergent combinatorial peptide libraries, or 'mixotopes' represents an interesting approach for inducing broadly cross-reactive immune response to hypervariable pathogens. The authors have immunized rabbits with a series of eight HIV-1 V3-loop derived constructs of increasing complexity, and analysed...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(97)00079-0
更新日期:1997-10-01 00:00:00
abstract:OBJECTIVES:Yearly vaccination against influenza is currently recommended to patients with rheumatoid Arthritis (RA). Antibody and cell-mediated responses are both involved in the defense against influenza. Humoral responses to influenza vaccine are impaired in RA patients treated with rituximab (RTX). The objectives of...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2010.12.072
更新日期:2011-02-11 00:00:00
abstract::During the 2009/10 pandemic of influenza A (H1N1), the American Society of Transplantation and other health organizations recommended that immunocompromised patients should be vaccinated as the key preventive measure. Since there are no data available for the immunogenicity of the unadjuvanted pandemic influenza vacci...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.07.050
更新日期:2011-09-16 00:00:00
abstract:BACKGROUND:Vaccines are specific medicines characterized by two country-specific market access processes: (1) a recommendation by National Immunization Technical Advisory Group (NITAG), and (2) a funding policy decision. OBJECTIVES:The objective of this study was to compare and analyze NITAGs of 13 developed countries...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2014.09.023
更新日期:2015-01-01 00:00:00
abstract::Vaccination remains the most cost-effective biomedical approach for controlling influenza disease. In times of pandemics, however, these vaccines cannot be produced in sufficient quantities for worldwide use by the current manufacturing capacities and practices. What is needed is the development of adjuvanted vaccines...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2018.05.029
更新日期:2018-06-14 00:00:00
abstract:INTRODUCTION:New adjuvants such as the AS- or the MF59-adjuvants improve vaccine efficacy and facilitate dose-sparing. Their use in influenza and malaria vaccines has resulted in a large body of evidence on their clinical safety in children. METHODS:We carried out a systematic search for safety data from published cli...
journal_title:Vaccine
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.vaccine.2015.12.024
更新日期:2016-02-03 00:00:00
abstract::Eggs are a major source of human infections with Salmonella. Therefore controlling egg contamination in laying hen flocks is one of the main targets for control programmes. A study was carried out to assess the effect of oral vaccination with TAD Salmonella vac E, TAD Salmonella vac T and with both vaccines TAD Salmon...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2006.05.070
更新日期:2006-09-11 00:00:00
abstract::In many industrialized countries, hepatitis A incidence rates have declined steadily in the past decades. Since future cohorts of non-vaccinated elderly will lack protection against disease and the burden of hepatitis A is higher with increasing age, this could be an argument in favour of taking preventive measures su...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2012.06.014
更新日期:2012-07-27 00:00:00
abstract:INTRODUCTION:The World Health Organization (WHO) recommends vaccination of health workers against influenza, but uptake in low-resource settings remains low. To complement routine global data collection efforts we conducted a detailed survey on influenza vaccination policies for health workers in low-income and middle-...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2020.10.001
更新日期:2020-11-03 00:00:00
abstract::The induction of oral tolerance against disease-inducing antigens has emerged as a feasible strategy to prevent immunopathologies. In this study, we investigated the effect of oral immunization with whole antigens of Leishmania amazonensis promastigotes (LaAg) on murine cutaneous leishmaniasis. We found that two oral ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(03)00427-4
更新日期:2003-09-08 00:00:00
abstract::A gene encoding the mature Escherichia coli heat-labile enterotoxin B subunit (LTB) was introduced in a vector pNU212 and expressed at high levels in Bacillus brevis HPD31. The maximum amount of recombinant LTB (rLTB) secreted into the modified 5PY medium containing erythromycin was about 350 mg l(-1) when cultivated ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(99)00547-2
更新日期:2000-03-06 00:00:00