Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu®.

Abstract:

:Anflu® is a seasonal trivalent inactivated split-virion influenza vaccine manufactured by Sinovac Biotech Co., Ltd. The objectives of this study were to evaluate the safety of Anflu® (2013-14 formulation: H1N1, H3N2 and BYAM) in infants and adults and its immunogenicity and cross-reactivity against mismatched influenza B lineage and avian influenza A(H7N9) viruses (hereafter BVIC and H7N9, respectively) in adults. In this phase IV open label trial, infants 6-35 months old (n=61) each received two injections with 28 days apart; adults 18-60 yrs old (n=60) and elderly >60 yrs old (n=61) each received one injection. Information of adverse events was collected through safety observation and follow-up visits. Pre- and post-immune blood samples (day 0 and 21) were collected from subjects ≥18 yrs old to detect hemagglutination inhibition antibody titers and calculate seroprotection rates (SPRs) and seroconversion rates (SCRs). The overall adverse reaction incidence was 1.6% (3/182), and no serious adverse event was reported during the study period. For subjects ≥18 yrs old, the SCRs, SPRs, and the geometric mean titers (GMTs) met the European criteria for all three strains. In addition, the point estimations of SCR, SPR and GMT for BVIC also met the European criteria. Six subjects were seroconverted against H7N9; however the serological results did not meet the European criteria. In conclusion, the results showed a satisfactory safety and immunogenicity profile of Anflu® and cross-reactivity against BVIC, but did not demonstrate cross-reactivity against H7N9 (Clinicaltrials.gov ID: NCT02269852).

journal_name

Hum Vaccin Immunother

authors

Shen Y,Hu Y,Meng F,Du W,Li W,Song Y,Ji X,Huo L,Fu Z,Yin W

doi

10.1080/21645515.2015.1123357

subject

Has Abstract

pub_date

2016-05-03 00:00:00

pages

1229-34

issue

5

eissn

2164-5515

issn

2164-554X

journal_volume

12

pub_type

杂志文章
  • Rotavirus capsid VP6 protein acts as an adjuvant in vivo for norovirus virus-like particles in a combination vaccine.

    abstract::Rotavirus (RV) and norovirus (NoV) are the 2 leading causes of acute viral gastroenteritis worldwide. We have developed a non-live NoV and RV vaccine candidate consisting of NoV virus-like particles (VLPs) and recombinant polymeric RV VP6 protein produced in baculovirus-insect cell expression system. Both components h...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2015.1099772

    authors: Blazevic V,Malm M,Arinobu D,Lappalainen S,Vesikari T

    更新日期:2016-03-03 00:00:00

  • The intentions to get vaccinated against influenza and actual vaccine uptake among diabetic patients in Ningbo, China: identifying motivators and barriers.

    abstract:BACKGROUND:Health authorities recommend influenza vaccination to diabetic patients. Nevertheless, the vaccination coverage of adults was low in China. This study aimed to estimate influenza vaccination intentions and actual uptake among diabetic patients in China and identify the motivators and barriers associated with...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1761201

    authors: Ye L,Fang T,Cui J,Zhu G,Ma R,Sun Y,Li P,Li H,Dong H,Xu G

    更新日期:2020-05-27 00:00:00

  • Prevalent levels of RSV serum neutralizing antibodies in healthy adults outside the RSV-season.

    abstract::One of the main challenges in early clinical research with respiratory syncytial virus (RSV) live-attenuated vaccines (LAVs) is to assess immunogenicity in healthy adults. Healthy adults will have preexisting levels of serum neutralizing antibodies that could prematurely neutralize the LAV and underestimate the potent...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2019.1688040

    authors: Van Der Plas JL,Verdijk P,Van Brummelen EMJ,Jeeninga RE,Roestenberg M,Burggraaf J,Kamerling IMC

    更新日期:2020-06-02 00:00:00

  • Empathy in vaccination counselling: a survey on the impact of a three-day residential course.

    abstract:BACKGROUND:In an era of hesitance to use vaccines, the importance of effective communication for increasing vaccine acceptance is well known. This study aimed to assess the impact of a three-day residential course concerning empathy and counselling abilities on patients' ratings of the level of empathy of physicians an...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2018.1536587

    authors: Maurici M,Arigliani M,Dugo V,Leo C,Pettinicchio V,Arigliani R,Franco E

    更新日期:2019-01-01 00:00:00

  • Maternal immunization. Clinical experiences, challenges, and opportunities in vaccine acceptance.

    abstract::Maternal immunization holds tremendous promise to improve maternal and neonatal health for a number of infectious conditions. The unique susceptibilities of pregnant women to infectious conditions, as well as the ability of maternally-derived antibody to offer vital neonatal protection (via placental transfer), togeth...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.4161/21645515.2014.970901

    authors: Moniz MH,Beigi RH

    更新日期:2014-01-01 00:00:00

  • Public awareness regarding children vaccination in Jordan.

    abstract::Immunization can contribute to a dramatic reduction in number of vaccine-preventable diseases among children. The aim of this study is to investigate mothers' awareness about child vaccines and vaccination in Jordan. This study was a community-based, cross-sectional study that was performed at public places in Irbid C...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.28608

    authors: Masadeh MM,Alzoubi KH,Al-Azzam SI,Al-Agedi HS,Abu Rashid BE,Mukattash TL

    更新日期:2014-01-01 00:00:00

  • Potential effect of PCV13 introduction on Emergency Department accesses for lower respiratory tract infections in elderly and at risk adults.

    abstract::Liguria, an administrative region in northern Italy characterized by a decade of high PCV coverage in paediatric age group, has issued new PCV13 recommendations for free active immunization in adults with risk factors and subjects aged ≥ 70 years old. Main aims of this study are: (1) a descriptive epidemiology of the ...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.34419

    authors: Ansaldi F,Orsi A,Trucchi C,De Florentiis D,Ceravolo A,Coppelli M,Schiaffino S,Turello V,Rosselli R,Carloni R,Icardi G,Study Group LP,Canepa P,Sticchi L,Zanetti R,Cremonesi I,Brasesco P,Moscatelli P

    更新日期:2015-01-01 00:00:00

  • Product review: avelumab, an anti-PD-L1 antibody.

    abstract::Although immunotherapies have been employed for many decades, immune checkpoint inhibitors have only recently entered the oncologic landscape. Avelumab is a fully human monoclonal antibody that blocks the interaction between PD-L1 on tumor cells and PD-1 on T cells, thereby inhibiting immunosuppression in the tumor mi...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.1080/21645515.2018.1551671

    authors: Collins JM,Gulley JL

    更新日期:2019-01-01 00:00:00

  • Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial.

    abstract::As a stepping stone toward evaluation in infants, the safety and immunogenicity of an investigational 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (12vPHiD-CV) was assessed in toddlers. 12vPHiD-CV contains CRM197-conjugated capsular polysaccharides of serotypes 6A and 19A in a...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1810493

    authors: Horn M,Behre U,Traskine M,Dobbelaere K,Borys D

    更新日期:2020-11-11 00:00:00

  • A vaccinia virus renaissance: new vaccine and immunotherapeutic uses after smallpox eradication.

    abstract::In 1796, Edward Jenner introduced the concept of vaccination with cowpox virus, an Orthopoxvirus within the family Poxviridae that elicits cross protective immunity against related orthopoxviruses, including smallpox virus (variola virus). Over time, vaccinia virus (VACV) replaced cowpox virus as the smallpox vaccine,...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.4161/hv.21080

    authors: Verardi PH,Titong A,Hagen CJ

    更新日期:2012-07-01 00:00:00

  • Obesity-induced chronic inflammation is associated with the reduced efficacy of influenza vaccine.

    abstract::The relationship between obesity and vaccine efficacy is a serious issue. Previous studies have shown that vaccine efficacy is lower in the obese than in the non-obese. Here, we examined the influence of obesity on the efficacy of influenza vaccination using high fat diet (HFD) and regular fat diet (RFD) mice that wer...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.28332

    authors: Park HL,Shim SH,Lee EY,Cho W,Park S,Jeon HJ,Ahn SY,Kim H,Nam JH

    更新日期:2014-01-01 00:00:00

  • Two cases of disseminated BCG disease following vaccination in the same family: case reports and review of the literature in China.

    abstract::Disseminated bacillus Calmette-Guérin (BCG) disease is a rare and serious adverse event following immunization (AEFI) with BCG. Here, we reported two cases of disseminated BCG disease in the same family and reviewed the literature to identify another 35 cases in China. The average age at onset was 3.7 ± 2.1 months amo...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1819102

    authors: Wang J,Wu QS,Jiang MB,Xu ZH

    更新日期:2020-10-20 00:00:00

  • Staphylococcus aureus and Streptococcus pneumoniae interaction and response to pneumococcal vaccination: Myth or reality?

    abstract::S. aureus and S. pneumoniae are both common pathogens that are also carried by a large proportion of healthy individuals in the nasal and nasopharyngeal spaces. A negative association between carriage of S. aureus and S. pneumoniae has been reported in children in various epidemiologic studies from different geographi...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.1080/21645515.2015.1081321

    authors: Reiss-Mandel A,Regev-Yochay G

    更新日期:2016-01-01 00:00:00

  • Immunization services offered in Québec (Canada) pharmacies.

    abstract::Canadian Pharmacists are easy to reach. Although Québec pharmacists are not allowed to administer vaccines, they can: (1) promote vaccination, (2) counsel patients on vaccination, (3) sell vaccines and (4) provide vaccine administration by a nurse. Our objectives were to describe immunization services given in Québec ...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.25186

    authors: Sauvageau C,Dubé E,Bradet R,Mondor M,Lavoie F,Moisan J

    更新日期:2013-09-01 00:00:00

  • Serological response to trivalent inactivated influenza vaccine in HIV-infected adults in Singapore.

    abstract::A cohort of 81 HIV-infected participants received seasonal trivalent inactivated influenza vaccine (TIV) and their humoral responses were monitored using hemagglutination inhibition (HAI) assay and enzyme-linked immunosorbent assay (ELISA). Three weeks after the vaccination, the percentage of the cohort that had an HA...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2016.1246636

    authors: Lau YF,Tang LH,Chien Lye D,Ooi EE,Leo YS

    更新日期:2017-03-04 00:00:00

  • Penta is associated with an increased female-male mortality ratio: cohort study from Bangladesh.

    abstract::Diphtheria-tetanus-pertussis (DTP) vaccine may be associated with excess female deaths. There are few studies of possible nonspecific effects of the DTP-containing vaccine Penta (DTP-hepatitis B-Haemophilus influenzae type b). We therefore investigated whether Penta vaccinations were associated with excess female deat...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1763084

    authors: Hanifi SMA,Biering-Sørensen S,Jensen AKG,Aaby P,Bhuiya A

    更新日期:2020-06-23 00:00:00

  • Allergen-specific IgG as a mediator of allergy inhibition: Lessons from mother to child.

    abstract::Allergen-specific IgG produced by immune mothers is associated with less predisposition to allergy development in their children. This finding has been described by several groups over the last few decades, but the mechanisms by which maternal IgG can inhibit allergy development are still not fully understood. With th...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.1080/21645515.2016.1244592

    authors: Victor JR

    更新日期:2017-03-04 00:00:00

  • Mucosal genetic immunization through microsphere-based oral carriers.

    abstract::Polymeric carriers in the form of cellulose acetate phthalate (CAP) and alginate (ALG) microspheres were used for encapsulation of plasmid DNA for oral mucosal immunization. Access into the intestinal mucosa by pVAX1 eukaryotic expression plasmid vectors carrying gene-coding sequences, either for the cholera enterotox...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.25325

    authors: Rosli R,Nograles N,Hanafi A,Nor Shamsudin M,Abdullah S

    更新日期:2013-10-01 00:00:00

  • Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin.

    abstract::One combined measles-mumps-rubella (MMR) vaccine without Human Serum Albumin (HSA) is currently licensed in the USA (M-M-R II; Merck, USA) and another has been developed (Priorix™ [MMR-RIT, GSK, Belgium]). In this follow-up study, children from USA or Puerto Rico, who had received one dose of M-M-R II or MMR-RIT at 12...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1080/21645515.2017.1309486

    authors: Berry AA,Abu-Elyazeed R,Diaz-Perez C,Mufson MA,Harrison CJ,Leonardi M,Twiggs JD,Peltier C,Grogg S,Carbayo A,Shapiro S,Povey M,Baccarini C,Innis BL,Henry O

    更新日期:2017-07-03 00:00:00

  • Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine.

    abstract::Current cancer immunotherapies predominantly rely on CD8(+) T cells to fight against tumors. However accumulative evidence showed that proinflammatory CD4(+) helper T cells are critical determinants of effective antitumor immunity. The utilization of universal tumor-reactive helper peptides from telomerase represents ...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.4161/hv.23587

    authors: Adotévi O,Dosset M,Galaine J,Beziaud L,Godet Y,Borg C

    更新日期:2013-05-01 00:00:00

  • Predicting the impact of pneumococcal conjugate vaccine programme options in Vietnam.

    abstract::Although catch-up campaigns (CCs) at the introduction of pneumococcal conjugate vaccines (PCVs) may accelerate their impact, supply constraints may limit their benefit if the need for additional PCV doses results in introduction delay. We studied the impact of PCV13 introduction with and without CC in Nha Trang, Vietn...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2018.1467201

    authors: Le Polain De Waroux O,Edmunds WJ,Takahashi K,Ariyoshi K,Mulholland EK,Goldblatt D,Choi YH,Anh DD,Yoshida LM,Flasche S

    更新日期:2018-01-01 00:00:00

  • Zika vaccine pre-clinical and clinical data review with perspectives on the future development.

    abstract::Zika is an arboviral illness caused by infection with the Zika flavivirus. Transmission most commonly occurs during a feeding event involving an infected Aedes mosquito or vertical transmission between an infected mother to her fetus. Infection outcomes range from asymptomatic to devastating neurologic injuries in chi...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1730657

    authors: Thomas SJ,Barrett A

    更新日期:2020-10-02 00:00:00

  • Clinical and cost burden of rotavirus infection before and after introduction of rotavirus vaccines among commercially and Medicaid insured children in the United States.

    abstract::This study aims to quantify clinical and economic burden of rotavirus (RV) infection pre- and post-vaccine introduction in commercially insured and Medicaid populations. Beneficiaries with continuous enrollment for ≥6 months while <5 years of age were identified separately in commercial (2000-2010) and Medicaid (2002-...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.29511

    authors: Krishnarajah G,Demissie K,Lefebvre P,Gaur S,Sheng Duh M

    更新日期:2014-01-01 00:00:00

  • Mortality among recipients of the Merck V710 Staphylococcus aureus vaccine after postoperative S. aureus infections: an analysis of possible contributing host factors.

    abstract::In a blinded randomized trial, preoperative receipt of the Merck V710 Staphylococcus aureus vaccine was associated with a higher mortality rate than placebo in patients who later developed postoperative S. aureus infections. Of the tested patients, all 12 V710 recipients (but only 1 of 13 placebo recipients) with unde...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.4161/hv.34407

    authors: McNeely TB,Shah NA,Fridman A,Joshi A,Hartzel JS,Keshari RS,Lupu F,DiNubile MJ

    更新日期:2014-01-01 00:00:00

  • Coronavirus disease 2019 (COVID-19) in domestic animals and wildlife: advances and prospects in the development of animal models for vaccine and therapeutic research.

    abstract::SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), is suspected to have been first contracted via animal-human interactions; it has further spread across the world by efficient human-to-human transmission. Recent reports of COVID-19 in companion animals (dogs and cats) and wild carnivores such as tigers hav...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.1080/21645515.2020.1807802

    authors: Sharun K,Tiwari R,Patel SK,Karthik K,Iqbal Yatoo M,Malik YS,Singh KP,Panwar PK,Harapan H,Singh RK,Dhama K

    更新日期:2020-12-01 00:00:00

  • Lot-to-lot consistency study of the fully liquid pentavalent DTwP-HepB-Hib vaccine Quinvaxem (®) demonstrating clinical equivalence, suitability of the vaccine as a booster and concomitant administration with measles vaccine.

    abstract::This double-blind, randomized study evaluated the immunogenicity and safety of three production lots of the fully liquid combination DTwP-Hep-Hib vaccine, Quinvaxem (®) (Crucell, The Netherlands) in 360 healthy infants aged 42-64 d old given at 6, 10 and 14 weeks of age (Core Study). The Core Study was followed by an...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.4161/hv.21095

    authors: Aspinall S,Traynor D,Bedford P,Hartmann K

    更新日期:2012-08-01 00:00:00

  • Association of vaccine awareness and confidence on the influenza vaccination status of Al Ahsa, Saudi Arabia residents.

    abstract::While the Saudi Arabian Ministry of Health has made seasonal influenza vaccination available for several years, there remains a scarcity of vaccination coverage reports outside of the capital city. Understanding factors that affect vaccine uptake is important in developing strategies to improve coverage. This analytic...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1855954

    authors: Al Hassan YT,Fabella EL,Estrella ED,Al Ramadan HA,Al Rajeh AM,Al Saleh FH

    更新日期:2021-01-30 00:00:00

  • Meningococcal serogroup Y disease in Europe: Continuation of high importance in some European regions in 2013.

    abstract::Neisseria meningitidis or meningococcus is divided into 12 distinct serogroups of which A, B, C, W, X, and Y are medically most important and cause health problems in different parts of the world. The epidemiology of N. meningitidis is unpredictable over time and across geographic regions. Globally, serogroup A has be...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2015.1051276

    authors: Bröker M,Emonet S,Fazio C,Jacobsson S,Koliou M,Kuusi M,Pace D,Paragi M,Pysik A,Simões MJ,Skoczynska A,Stefanelli P,Toropainen M,Taha MK,Tzanakaki G

    更新日期:2015-01-01 00:00:00

  • Different roles of interleukin 6 and interleukin 11 in the liver: implications for therapy.

    abstract::The interleukin 6 (IL6) family of proteins regulate important cellular processes and act through a variety of signaling pathways via a shared gp130 receptor. In the liver, there is a large body of evidence showing a protective and pro-regenerative role for IL6 cis and trans signaling. While a few studies suggest a pat...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章

    doi:10.1080/21645515.2020.1761203

    authors: Widjaja AA,Chothani SP,Cook SA

    更新日期:2020-10-02 00:00:00

  • Pembrolizumab (Keytruda).

    abstract::The programmed cell death protein 1 (PD1) is one of the checkpoints that regulates the immune response. Ligation of PD1 with its ligands PDL1 and PDL2 results in transduction of negative signals to T-cells. PD1 expression is an important mechanism contributing to the exhausted effector T-cell phenotype. The expression...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审

    doi:10.1080/21645515.2016.1199310

    authors: Kwok G,Yau TC,Chiu JW,Tse E,Kwong YL

    更新日期:2016-11-01 00:00:00