Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: a double-blind, randomized, parallel-controlled phase III clinical trial in China.

Abstract:

BACKGROUND:Viruses from two antigenically distinct influenza B strains have co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines (TIVs) with either the Victoria or Yamagata lineage could only provide limited protection from influenza B strain. Quadrivalent influenza vaccine (QIV) including both influenza B lineages can improve protection against circulating influenza B viruses. METHODS:Participants >/ = 3 years of age were recruited, stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). The primary objective of this study was to demonstrate that the hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not inferior to the licensed TIVs. RESULTS:First, 3661 participants received the inoculation. The QIV was found to be non-inferior to TIVs in terms of the geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies against shared strains 28 days after completion of inoculation, and was superior to the TIVs against the alternate B strain, which is absent from the TIVs. The occurrences of adverse events (AEs) post-vaccination were similar across the treatment groups. CONCLUSION:The experimental QIV showed good immunogenicity and an acceptable safety profile.

journal_name

Expert Rev Vaccines

authors

Wang SY,Liu SZ,Chu K,Zhao Y,Zhu FC,Hu YM,Meng FY,Li JX,Luo L,Yang JY,Liu P,Yu J

doi

10.1080/14760584.2017.1374181

subject

Has Abstract

pub_date

2017-11-01 00:00:00

pages

1155-1169

issue

11

eissn

1476-0584

issn

1744-8395

journal_volume

16

pub_type

杂志文章,随机对照试验
  • International Dengue Vaccine Communication and Advocacy: Challenges and Way Forward.

    abstract::Dengue vaccine introduction will likely occur soon. However, little has been published on international dengue vaccine communication and advocacy. More effort at the international level is required to review, unify and strategically disseminate dengue vaccine knowledge to endemic countries' decision makers and potenti...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.2016.1152187

    authors: Carvalho A,Van Roy R,Andrus J

    更新日期:2016-01-01 00:00:00

  • Survey of vaccine distribution and delivery issues in the USA: from pediatrics to pandemics.

    abstract::Vaccine distribution and delivery has become an issue of significant interest, given the threat of a pandemic influenza outbreak and the resulting need for coordinated efforts to distribute and deliver pandemic influenza vaccines into the hands of healthcare workers responsible for administering them. This review prov...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.6.6.981

    authors: Jacobson SH,Sewell EC,Jokela JA

    更新日期:2007-12-01 00:00:00

  • Global impact of rotavirus vaccines.

    abstract::The WHO has recently recommended the inclusion of rotavirus vaccine in the national immunization programs of all countries. In countries in the Americas, Europe and Australia that have adopted routine childhood immunization against rotavirus, significant reductions in the burden of severe childhood diarrhea have been ...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.10.17

    authors: Tate JE,Patel MM,Steele AD,Gentsch JR,Payne DC,Cortese MM,Nakagomi O,Cunliffe NA,Jiang B,Neuzil KM,de Oliveira LH,Glass RI,Parashar UD

    更新日期:2010-04-01 00:00:00

  • Chinese vaccine products go global: vaccine development and quality control.

    abstract::Through the continuous efforts of several generations, China has become one of the few countries in the world that is capable of independently addressing all the requirements by the Expanded Program on Immunization. Regulatory science is applied to continuously improve the vaccine regulatory system. Passing the prequa...

    journal_title:Expert review of vaccines

    pub_type: 历史文章,杂志文章,评审

    doi:10.1586/14760584.2015.1012503

    authors: Xu M,Liang Z,Xu Y,Wang J

    更新日期:2015-05-01 00:00:00

  • Streptococcus pneumoniae serotype 19A: worldwide epidemiology.

    abstract:INTRODUCTION:Streptococcus pneumoniae causes mucosal and invasive diseases with high morbidity and mortality. Introduction of the 7-valent pneumococcal conjugate vaccine (PCV7) into routine infant immunization programs worldwide resulted in serotype 19A becoming a leading cause of the remaining pneumococcal disease bur...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1080/14760584.2017.1362339

    authors: Isturiz R,Sings HL,Hilton B,Arguedas A,Reinert RR,Jodar L

    更新日期:2017-10-01 00:00:00

  • The challenge of assessing infant vaccine responses in resource-poor settings.

    abstract::Newborns and infants are highly susceptible to infectious diseases, resulting in high mortality and morbidity, particularly in resource-poor settings. Many vaccines require several booster doses, resulting in an extensive vaccine schedule, and yet there is still inadequate protection from some of these diseases. This ...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.10.41

    authors: Flanagan KL,Burl S,Lohman-Payne BL,Plebanski M

    更新日期:2010-06-01 00:00:00

  • Vaccines against atherosclerosis.

    abstract::Atherosclerosis is the primary cause of acute myocardial infarction and stroke. It is well established that arterial inflammation in response to accumulation and oxidation of lipoproteins in the vascular wall is the major factor responsible for the development of atherosclerosis. During recent years, it has become app...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.13.4

    authors: Nilsson J,Wigren M,Shah PK

    更新日期:2013-03-01 00:00:00

  • The Ebola virus glycoprotein and its immune responses across multiple vaccine platforms.

    abstract::Introduction: For over 40 years, ebolaviruses have been responsible for sporadic outbreaks of severe and often fatal hemorrhagic fever in humans and nonhuman primates across western and central Africa. In December 2013, an unprecedented Ebola virus (EBOV) epidemic began in West Africa and resulted in the largest outbr...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1080/14760584.2020.1738225

    authors: O'Donnell K,Marzi A

    更新日期:2020-03-01 00:00:00

  • Recent progress in peptide vaccination in cancer with a focus on non-small-cell lung cancer.

    abstract::Active immunotherapy aimed at the stimulation of tumor-specific T cells has established itself within the clinic as a therapeutic option to treat cancer. One strategy is the use of so-called peptides that mimic genuine T-cell epitopes as vaccines to activate tumor-specific T cells. In various clinical trials, differen...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.2014.862499

    authors: Talebian Yazdi M,Keene KR,Hiemstra PS,van der Burg SH

    更新日期:2014-01-01 00:00:00

  • Pediatric combined formulation DTaP-IPV/Hib vaccine.

    abstract::Combination vaccines have been used for many years in the USA as part of the primary infant immunization series. However, the current program still requires up to 24 injections by 18 months of age. The Advisory Committee on Immunization Practices in the USA recommends the use of combination vaccines whenever possible....

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.09.59

    authors: White C,Halperin SA,Scheifele DW

    更新日期:2009-07-01 00:00:00

  • TLR9 and endogenous adjuvants of the whole blood-stage malaria vaccine.

    abstract::Vaccination has been a successful tool in the protection against many infectious diseases, and recent advances in biotechnology have created new techniques and strategies to produce safe and efficacious vaccines for human use. However, developing a protective vaccine against malaria has been a challenge. In this artic...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.10.60

    authors: Coban C,Horii T,Akira S,Ishii KJ

    更新日期:2010-07-01 00:00:00

  • Can Neisseria lactamica antigens provide an effective vaccine to prevent meningococcal disease?

    abstract::Neisseria lactamica is a commensal organism that is closely related to Neisseria meningitidis, the causative agent of meningococcal disease. N. lactamica has many antigens in common with N. meningitidis, but it lacks a polysaccharide capsule and the serosubtyping antigen PorA. Carriage studies have demonstrated that N...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.4.3.373

    authors: Gorringe AR

    更新日期:2005-06-01 00:00:00

  • Immunogenicity, effectiveness and safety of combined hepatitis A and B vaccine: a systematic literature review.

    abstract:BACKGROUND:Hepatitis A and B are two of the most common vaccine-preventable diseases and vaccination for Hepatitis A virus (HAV) and hepatitis B virus (HBV) is recommended for those at risk of contracting HAV and/or HBV through their occupation, travel or lifestyle. OBJECTIVE:To describe the vaccine efficacy, immunoge...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.2016.1150182

    authors: Bakker M,Bunge EM,Marano C,de Ridder M,De Moerlooze L

    更新日期:2016-07-01 00:00:00

  • Usefulness of influenza vaccination during pregnancy to mothers and young infants.

    abstract::As pregnant women are at increased risk of influenza infection and influenza-related complications, immunization with inactivated influenza vaccine during the influenza season is recommended. Vaccination during pregnancy is considered to provide benefits for both the mothers and their young infants. In 2009, the novel...

    journal_title:Expert review of vaccines

    pub_type: 评论,杂志文章

    doi:10.1586/erv.12.67

    authors: Hisano M,Yamaguchi K

    更新日期:2012-08-01 00:00:00

  • Phagocytosis of synthetic particulate vaccine delivery systems to program dendritic cells.

    abstract::Therapeutic prospects of particulates are increasingly recognized for vaccination purposes. Compared with biologic particulates, such as live or attenuated bacterial vectors and viral vectors, synthetic particulates may be expected to ease the hurdles of quality assurance and validation in vaccine development and prod...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.1.2.215

    authors: Thiele L,Merkle HP,Walter E

    更新日期:2002-08-01 00:00:00

  • Intracellular detection and immune signaling pathways of DNA vaccines.

    abstract::Parallel to attenuated and subunit vaccines, DNA vaccines require adjuvant signals in addition to antigen presentation for the induction of adaptive immune responses. As opposed to common beliefs, increasing evidence is showing that Toll-like receptor 9 activation by CpG motifs present in DNA vaccines are not vital fo...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.09.79

    authors: Tang CK,Pietersz GA

    更新日期:2009-09-01 00:00:00

  • Dengue virus envelope protein domain I/II hinge: a key target for dengue virus vaccine design?

    abstract::Dengue virus is the most significant arboviral pathogen worldwide with nearly 400 million infections annually and half the global population at risk of disease. Despite this tremendous public health burden, there are no licensed treatments or vaccines to prevent dengue in humans. Results from clinical trials of leadin...

    journal_title:Expert review of vaccines

    pub_type: 社论

    doi:10.1586/14760584.2015.961431

    authors: Widman DG,Baric RS

    更新日期:2015-01-01 00:00:00

  • Varicella prevention in Costa Rica: impact of a one-dose schedule universal vaccination.

    abstract:INTRODUCTION:To describe the impact following a 1-dose Varicella vaccination schedule introduced in Costa Rica in September 2007. Areas covered: This is a retrospective review using epidemiologic surveillance national databases of varicella cases and hospitalizations, period 2000-2015. We analyzed age-related varicella...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1080/14760584.2017.1247700

    authors: Avila-Aguero ML,Ulloa-Gutierrez R,Camacho-Badilla K,Soriano-Fallas A,Arroba-Tijerino R,Morice-Trejos A

    更新日期:2017-03-01 00:00:00

  • Immunization: a global challenge for the 21st Century.

    abstract::The 9th Canadian Immunization Conference was held on 5-8 December 2010 in Quebec City, Canada. Over 1000 academic, public health and vaccine industry scientists, nurses, pharmacists, physicians and policy makers attended the conference, which was organized by the Public Health Agency of Canada-Centre for Immunization ...

    journal_title:Expert review of vaccines

    pub_type:

    doi:10.1586/erv.11.34

    authors: Langley JM,Naus M

    更新日期:2011-04-01 00:00:00

  • Environmental factors which can affect the burden of pneumococcal disease and the immune response to pneumococcal vaccines: the need for more precisely delineated vaccine recommendations.

    abstract::Introduction: Precision medicine describes the customization of healthcare tailored to the individual patient. Generally, vaccines are considered as public health tools rather than from the individual patient perspective. However, adult vaccination programs in particular should consider many different factors, at the ...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1080/14760584.2019.1607303

    authors: Park SB,Kim HJ,Cheong HJ

    更新日期:2019-06-01 00:00:00

  • Recent developments in mucosal vaccines against prion diseases.

    abstract::Bovine spongiform encephalopathy in cattle is highly suspected to be orally transmitted to humans through contaminated food, causing new variant Creutzfeldt-Jakob disease. However, no prophylactic procedures against these diseases, such as vaccines, in particular those stimulating mucosal protective immunity, have bee...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.6.1.75

    authors: Sakaguchi S,Arakawa T

    更新日期:2007-02-01 00:00:00

  • Insect cell technology is a versatile and robust vaccine manufacturing platform.

    abstract::Baculovirus and insect cell culture technologies have mostly been limited to research laboratories for the transient expression of target proteins for drug development purposes. With the renaissance of the vaccine field and the regulatory acceptance of recombinant DNA technology, the baculovirus expression system has ...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.11.24

    authors: Mena JA,Kamen AA

    更新日期:2011-07-01 00:00:00

  • Challenges in estimating influenza vaccine effectiveness.

    abstract::Introduction: Influenza vaccination is regarded as the most effective way to prevent influenza infection. Due to the rapid genetic changes that influenza viruses undergo, seasonal influenza vaccines must be reformulated and re-administered annually necessitating the evaluation of influenza vaccine effectiveness (VE) e...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1080/14760584.2019.1622419

    authors: Ainslie KEC,Haber M,Orenstein WA

    更新日期:2019-06-01 00:00:00

  • Intradermal naked plasmid DNA immunization: mechanisms of action.

    abstract::Plasmid DNA is a promising vaccine modality that is regularly examined in prime-boost immunization regimens. Recent advances in skin immunity increased our understanding of the sophisticated cutaneous immune network, which revived scientific interest in delivering vaccines to the skin. Intradermal administration of pl...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.11.66

    authors: Elnekave M,Furmanov K,Hovav AH

    更新日期:2011-08-01 00:00:00

  • Suppressor of cytokine signaling 1 inhibition strategy to enhance anti-HIV vaccination.

    abstract::Extensive efforts aimed at stimulating immune responses by modifying HIV antigens and using various delivery systems and adjuvants have so far failed to generate promising HIV vaccines, highlighting the urgent need to explore alternative immunization approaches. Antigen-presenting cells, such as dendritic cells, play ...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.5.4.495

    authors: Song XT,Aldrich M,Chen SY

    更新日期:2006-08-01 00:00:00

  • Alternative administration routes and delivery technologies for polio vaccines.

    abstract::Global polio eradication is closer than ever. Replacement of the live attenuated oral poliovirus vaccine (OPV) by inactivated poliovirus vaccine (IPV) is recommended to achieve complete eradication. Limited global production capacity and relatively high IPV costs compared to OPV spur the need for improved polio vaccin...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.2016.1158650

    authors: Kraan H,van der Stel W,Kersten G,Amorij JP

    更新日期:2016-08-01 00:00:00

  • Recombinant cancer vaccines and new vaccine targets. Interview by Jenaid Rees.

    abstract::Interview by Jenaid Rees, Commissioning Editor Jeffrey Schlom obtained his PhD from Rutgers University (NJ, USA). After obtaining his PhD, he worked at Columbia University (NY, USA) before moving in 1973 to the National Cancer Institute, National Institutes of Health (MD, USA). Since then he has served as the Chief of...

    journal_title:Expert review of vaccines

    pub_type: 传,历史文章,面试

    doi:10.1586/14760584.2013.836913

    authors: Schlom J

    更新日期:2013-10-01 00:00:00

  • In utero exposure to biologic disease-modifying anti-rheumatic drugs and effects to the infant: infectious complications, vaccine response, and safety of live vaccine administration.

    abstract:INTRODUCTION:Biologic disease-modifying anti-rheumatic drugs (bDMARDS) are increasingly used in clinical practice for a variety of conditions. Due to concerns surrounding persistence of drug levels and resulting immunosuppression, current case reports recommend against live vaccine administration in the first year of l...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1080/14760584.2019.1599286

    authors: Berkhout A,Clark JE,Wen SC

    更新日期:2019-05-01 00:00:00

  • Advances in vaccine development against the pre-erythrocytic stage of Plasmodium falciparum malaria.

    abstract::With approximately 2.4 billion people at risk, Plasmodium falciparum malaria infection caused by an infectious bite of an Anopheles mosquito continues to be a major cause of mortality and morbidity, mainly in the tropics and subtropics. Measures to control the mosquito vector on a broad scale are expensive and need to...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/14760584.5.1.81

    authors: Walther M

    更新日期:2006-02-01 00:00:00

  • Virus-like particles as universal influenza vaccines.

    abstract::Current influenza vaccines are primarily targeted to induce immunity to the influenza virus strain-specific hemagglutinin antigen and are not effective in controlling outbreaks of new pandemic viruses. An approach for developing universal vaccines is to present highly conserved antigenic epitopes in an immunogenic con...

    journal_title:Expert review of vaccines

    pub_type: 杂志文章,评审

    doi:10.1586/erv.12.70

    authors: Kang SM,Kim MC,Compans RW

    更新日期:2012-08-01 00:00:00