Abstract:
BACKGROUND:A nasal influenza vaccine has been available only in a live attenuated form, which limits the range of recipients to immune-competent individuals. The present study evaluated a newly developed intranasal inactivated influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT) derived from E. coli (LTh(αK)). METHODS:The study was a randomized, double-blind, controlled phase I trial to evaluate the safety and immunogenicity of an intranasal vaccine containing the trivalent influenza HA antigen (7.5 µg each of A/California/7/09 (H1N1)-like virus, A/Victoria/210/2009 (H3N2) virus, and B/Brisbane/60/2008-like virus) in combination with 4 different doses of adjuvant LTh(αK) (7.5, 15, 30 or 45 μg) and 22.5 μg of influenza HA antigen alone (control vaccine). The vaccine was intranasally administered on Days 0 and 7. A safety evaluation commenced for 180 days, and hemagglutination inhibition (HI) antibody titers and nasal HA-specific IgA titers on Day 0 and Day 28 were assessed to determine whether an immunogenic response was elicited. RESULTS:From November 2012 to September 2013, a total of 36 subjects were enrolled. Twenty-four subjects received an adjuvanted vaccine, and 12 subjects received a control vaccine. The most common adverse event (AE) was mild nasal discomfort, and systemic AEs were mild fatigue and headache. Only two subjects discontinued the study because of an AE (one had grade 3 fever, and one had nodal arrhythmia). In the group with 45 μg of LTh(αK), the seroprotection rates were 100%, 100% and 80%, and the nasal IgA conversion factors were 7.90, 7.46 and 12.27 for the A/H3N2, A/H1N1 and split B strains, respectively. Adjuvant LTh(αK) vaccine showed a significant enhancement in mucosal immunity in split B -specific IgA. CONCLUSION:The intranasal inactivated influenza vaccine is generally safe, and the LTh(αK)-adjuvanted vaccine is more immunogenic than non-adjuvanted control vaccine. ClinicalTrials.gov Identifier: NCT03293732.
journal_name
Vaccinejournal_title
Vaccineauthors
Pan SC,Hsieh SM,Lin CF,Hsu YS,Chang M,Chang SCdoi
10.1016/j.vaccine.2019.02.006subject
Has Abstractpub_date
2019-03-28 00:00:00pages
1994-2003issue
14eissn
0264-410Xissn
1873-2518pii
S0264-410X(19)30189-6journal_volume
37pub_type
杂志文章,随机对照试验相关文献
VACCINE文献大全abstract::A formulation of recombinant hepatitis B surface antigen (HBsAg) combined with a novel adjuvant system, SBAS4--a combination of aluminium salt and monophosphoryl lipid A (MPL), was assessed in 27 healthy adult volunteers with a commercial vaccine (Engerix-B) as control. After three doses (0, 1, 6 months schedule), rea...
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)00254-5
更新日期:1998-04-01 00:00:00
abstract:METHODS AND OBJECTIVES:To estimate the infant vaccination coverage in Belgium, a random cluster sample according to the expanded program on immunization (EPI) cluster sampling technique was performed in 1999 in the Flemish (Flanders) and French (Wallonia) speaking community of Belgium. The objective was to document the...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(01)00307-3
更新日期:2001-10-15 00:00:00
abstract::Post-licensure real world evaluation of vaccine implementation is important for establishing evidence of vaccine effectiveness (VE) and programme impact, including indirect effects. Large cohort studies offer an important epidemiological approach for evaluating VE, but have inherent methodological challenges. Since Ma...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2015.07.062
更新日期:2015-09-11 00:00:00
abstract::Rabies is a fatal but preventable disease. Cell culture vaccines (CCV) and purified duck embryo vaccines (PDEV) are currently recommended by WHO for post-exposure prophylaxis. In India, a PDEV (Vaxirab) is being manufactured and is in use since 2003. In the present study, we have evaluated the safety, immunogenicity a...
journal_title:Vaccine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.vaccine.2009.09.090
更新日期:2009-12-10 00:00:00
abstract::Despite the licensure of the pneumococcal conjugate vaccine (PCV) in the US and other Western countries for over 14 years, as of September 2014 only 4 South Asian countries were using PCV in their universal immunization program. To generate momentum toward addressing this issue a "South Asia symposium on pneumococcal ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2016.03.071
更新日期:2016-05-17 00:00:00
abstract::The efficacy of chicken egg yolk homotypic antibodies specific for outer membrane proteins (OMP), lipopolysaccharide (LPS) or flagella (Fla) in controlling experimental salmonellosis in mice was investigated. Mice challenged orally with 2 x 10(9) c.f.u. of Salmonella enteritidis or 2 x 10(7) c.f.u. of S. typhimurium w...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(97)80916-4
更新日期:1998-02-01 00:00:00
abstract::We have just witnessed the largest and most devastating outbreak of Ebola virus disease, which highlighted the urgent need for development of an efficacious vaccine that could be used to curtail future outbreaks. Prior to 2014, there had been limited impetus worldwide to develop a vaccine since the virus was first dis...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2017.07.054
更新日期:2018-08-28 00:00:00
abstract:INTRODUCTION:Endemic measles persists in China, despite >95% reported coverage of two measles-containing vaccine doses and nationwide campaign that vaccinated more than 100 million children in 2010. In 2011, almost half of the 9943 measles cases in China occurred in children eligible for measles vaccination. We conduct...
journal_title:Vaccine
pub_type: 杂志文章,多中心研究
doi:10.1016/j.vaccine.2016.02.005
更新日期:2016-12-12 00:00:00
abstract::The PEDVAC study is the first trial designed to analyze safety and immunogenicity of a therapeutic vaccination with a multiclade multigene HIV DNA vaccine (HIVIS) in infected children. Twenty HIV-1 vertically infected children (6-16 years of age), on stable antiretroviral treatment for at least 6 months with HIV-1 RNA...
journal_title:Vaccine
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.vaccine.2010.12.058
更新日期:2011-09-09 00:00:00
abstract:INTRODUCTION:Older adults living in nursing homes (NH) are at high risk of developing influenza and pneumococcal infections. The objectives of this study were to describe vaccination coverage for influenza and pneumococcal among French NH residents and to investigate which NH structure- and organisation-related aspects...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2013.12.023
更新日期:2014-02-07 00:00:00
abstract:INTRODUCTION:Adolescents and young adults are at a high risk of developing human papillomavirus (HPV) infections, which can be prevented with the use of vaccines. Moreover, a combined immunization strategy for administration of HPV vaccines with other routine vaccines may lead to better compliance. We aim to comprehens...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2019.10.092
更新日期:2020-01-10 00:00:00
abstract::Protein C deletion mutants of West Nile virus (WNV) were evaluated for their potential use as live virus vaccine candidates in vivo. Double and triple mutants carrying small deletions and second-site point mutations, as well as mutants with large deletions of 36 and 37 amino acid residues were tested in a stringent mo...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2010.06.045
更新日期:2010-08-16 00:00:00
abstract:OBJECTIVES:To perform a systematic review of all serious adverse events (SAEs) after yellow fever vaccination and to assess them according to Brighton Collaboration criteria. METHODS:Nine electronic databases were searched with the terms "yellow fever vaccine" and "adverse events" to 10 July 2013 (no language/date lim...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2013.10.050
更新日期:2013-12-16 00:00:00
abstract::The outbreak of highly pathogenic avian influenza virus in North American poultry during 2014 and 2015 demonstrated the devastating effects of the disease and highlighted the need for effective emergency vaccine prevention and control strategies targeted at currently circulating strains. This study evaluated the effic...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2017.11.026
更新日期:2018-01-02 00:00:00
abstract::In order to perform preliminary evaluations of subunit vaccine candidates before extensive trials in large food-producing animals, an in vitro B-lymphocyte response assay, based on the principles of an ELISA, was established. The assay was developed in detail for the porcine system using antigens from the Gram-negativ...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/0264-410x(91)90149-z
更新日期:1991-03-01 00:00:00
abstract::To date, most peptide-based vaccines evaluated for the treatment of cancer have consisted of one or few peptides. However, as a greater number of peptide antigens become available for use in experimental therapies, it is important to establish the feasibility of combining multi-peptide reagents as individual peptide m...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.01.018
更新日期:2009-03-10 00:00:00
abstract::The canarypox vaccine vector (ALVAC) technology has been used to develop and license several vaccines for companion animals and horses in the European Union and USA. ALVAC is a ubiquitous vector with high biosafety since it is non-replicative in mammalians, is genetically and physically stable, and able to induce both...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2006.11.066
更新日期:2007-07-26 00:00:00
abstract::A recombinant Plasmodium falciparum circumsporozoite (CS) antigen (rPfCSA) was produced in insect cells using a baculovirus expression vector containing the entire CS gene. This near full-length CS antigen was adsorbed onto aluminium phosphate for use as a malaria vaccine. In a study of safety and immunogenicity, 20 v...
journal_title:Vaccine
pub_type: 临床试验,杂志文章
doi:10.1016/0264-410x(92)90047-n
更新日期:1992-01-01 00:00:00
abstract::The most common preventative measure against mumps is vaccination with mumps vaccine. In most parts of the world, mumps vaccine is routinely delivered through live attenuated Measles-Mumps-Rubella (MMR) vaccine. In Japan, receiving mumps vaccine is voluntary and vaccine uptake rate is less than 30%. The introduction o...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2014.05.020
更新日期:2014-07-16 00:00:00
abstract::The influenza immunization program in North America has been primarily designed to provide direct benefit to vaccinated individuals at highest risk of serious influenza outcomes. Some evidence suggests that immunization of certain age groups may also extend indirect protective benefit to vulnerable populations. Our go...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2007.11.090
更新日期:2008-03-04 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
abstract::Anti-angiogenesis represents an indispensible strategy for cancer therapy. As a strictly endothelial-specific adhesion molecule, vascular endothelial cadherin (VE-cadherin, VE-cad) is a promising anti-angiogenesis target. In this study a recombinant adenovirus vector modified with mannan was used to deliver VE-cad (Ad...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2011.03.109
更新日期:2011-06-06 00:00:00
abstract::An effective malaria vaccine remains a global health priority. Recombinant adenoviruses are a promising vaccine platform, and Plasmodium falciparum apical membrane antigen 1 (AMA1) and merozoite surface protein 1-42 (MSP1(42)) are leading blood stage vaccine candidates. We evaluated the importance of surface antigen l...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2010.02.024
更新日期:2010-04-19 00:00:00
abstract::Immune responses induced to DNA vaccination vary considerably and depend on a variety of factors, including the physical form in which the antigen is expressed by target cells and presented to the immune system. Data on the effect of these factors will aid improved design of DNA vaccines and facilitate their further d...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2005.03.016
更新日期:2005-07-14 00:00:00
abstract::Healthcare workers' (HCWs) knowledge, attitudes, and beliefs regarding pertussis immunization were assessed and compared to the rate of vaccine uptake. A questionnaire was distributed to employees at a paediatric and maternity tertiary care centre. Respondents were then offered a dose of the tetanus, diphtheria, and a...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2009.12.060
更新日期:2010-03-02 00:00:00
abstract::The seven-valent pneumococcal conjugate vaccine (PCV7) was added to the UK national immunisation programme in September 2006. PCV13 replaced PCV7 in April 2010. As carriage precedes disease cases this study collected carried pneumococci from children each winter from 2006/7 to 2010/11 over PCV introduction. Convention...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2015.03.012
更新日期:2015-04-21 00:00:00
abstract::Hepatitis B (HB) immunization was introduced as part of the expanded programme on immunization (EPI) in two provinces in Thailand and evaluated over a four year period. Three doses of HB vaccine were offered to 60,980 newborns at birth, 2 and 6 months of age. The overall coverage for complete HB immunization was 90.4%...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(96)00226-5
更新日期:1997-04-01 00:00:00
abstract::A modern approach to vaccination faces the compound complexity of microorganism behavior and immune response triggering and regulation. Since computational modeling can yield useful guidelines for biological experimentation, we have used IMMSIM(3), a cellular automaton model for simulating humoral- and cell-mediated r...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/s0264-410x(00)00225-5
更新日期:2000-11-22 00:00:00
abstract:BACKGROUND:China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing ...
journal_title:Vaccine
pub_type: 杂志文章,评审
doi:10.1016/j.vaccine.2012.11.051
更新日期:2013-01-11 00:00:00
abstract:PURPOSE:We conducted a cancer vaccine clinical trial with MAGE-A4 protein. Safety, clinical response, and antigen-specific immune responses were analyzed and the prognostic factors by vaccination were investigated. EXPERIMENTAL DESIGN:Twenty patients with advanced esophageal, stomach or lung cancer were administered M...
journal_title:Vaccine
pub_type: 杂志文章
doi:10.1016/j.vaccine.2014.09.002
更新日期:2014-10-14 00:00:00