Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan.


BACKGROUND:The study was aimed at comparative evaluation of seasonal influenza vaccine RIBSP versus commercial vaccine VAXIGRIP® for immunogenicity and safety in the course of clinical trial phase II on healthy subjects up to 60 years. METHODS:The trial involved 150 subjects in randomized 2:1 groups that received either RIBSP vaccine or comparator vaccine VAXIGRIP®. One dose (0.5 ml) of either vaccine contained 15 µg of hemagglutinin of each influenza virus strain recommended by WHO for the Northern hemisphere in 2016-2017 flu season. The observation period lasted 21 days. The trial was registered at identifier NCT03016143. RESULTS:Assessment of immunogenic activity of the vaccine under study showed that in 21 days the portion of participants with 4-fold seroconversions was 80.0% to А/H1N1; 65.0% to А/H3N2 and 64.0% to B virus. Antibody titer increase factor in the group of subjects that received RIBSP vaccine was 13.4 for А/H1N1; 5.2 for А/H3N2 and 5.2 for B virus. The subjects that received RIBSP vaccine demonstrated 88% seroprotection rate against А/H1N1; 75% against А/H3N2 and 61% against B virus. In the course of evaluating the vaccine safety, no serious adverse events were recorded. All changes of laboratory data were slight and single in most cases. All recorded local reactions have been light in character and these have been predicted reactions observed at vaccination against influenza. CONCLUSION:Comparison vaccines RIBSP and VAXIGRIP®, showed similar immunogenic activity. The RIBSP vaccine is safe and immunogenic for the elderly and conforms to international criteria in CPMP/BWP/214/96.


Hum Vaccin Immunother


Sarsenbayeva G,Issagulov T,Kassenov M,Abitay R,Orynbayev M,Stukova M,Pisareva M,Davlyatshin T,Lespek K,Khairullin B




Has Abstract


2020-08-02 00:00:00












  • Safety of two doses of an inactivated hepatitis a vaccine given 6 months apart in healthy toddlers, children, and adolescents aged 12 months to 15 years in China: a phase IV study.

    abstract::Hepatitis A is a vaccine-preventable infection caused by the HA virus (HAV) with transitional to intermediate endemicity in China. An inactivated vaccine first licensed in China in 2010 (Avaxim® 80U Pediatric) is indicated for primary and booster vaccination in children from 12 months to 15 years of age. This Phase IV...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Shi N,Rasuli A,Thollot Y

    更新日期:2019-01-01 00:00:00

  • The regulatory T cells in anti-influenza antibody response post influenza vaccination.

    abstract::The efficacy and effectiveness of influenza vaccines depend primarily on the vaccine recipient and the virus similarity to the endemic virus. Regulatory T cells (Tregs) and cytokines are known to restrict immune responses against viral infections. We conducted this study to explore the role of Tregs, cytokines, and an...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 临床试验,杂志文章


    authors: Wang SM,Tsai MH,Lei HY,Wang JR,Liu CC

    更新日期:2012-09-01 00:00:00

  • Evaluating impact of school outreach vaccination programme in Hong Kong influenza season 2018 - 2019.

    abstract::School-based vaccination, as a means to mitigate seasonal influenza outbreak, depends on attaining adequate coverage rate. We evaluated the potential of a fully subsidized school outreach vaccination (SOV) program to achieve epidemic prevention potential in Hong Kong. The purpose of this study was to evaluate the impa...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Lau YL,Wong WHS,Hattangdi-Haridas SR,Chow CB

    更新日期:2020-04-02 00:00:00

  • Varicella vaccine strain infection in a non-immunocompromised patient. A case report and review of literature.

    abstract::Varicella live attenuated vaccine led to a significant reduction in morbidity and mortality from varicella zoster disease. Vaccine adverse effects are mostly mild. Immunosuppression is the main risk factor for severe varicella. Risk factors for disease following vaccination are less studied. We report a 12-month-old i...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Swed-Tobia R,Kassis I,Hanna S,Szwarcwort-Cohen M,Dovrat S,Dabaja-Younis H

    更新日期:2020-09-18 00:00:00

  • Immune persistence after pertussis vaccination.

    abstract::Pertussis is one of the most prevalent vaccine-preventable diseases worldwide. The true infection rate is significantly higher than the reported incidence rate. An increased prevalence of pertussis in older populations has been found, mainly caused by waning immunity after vaccination. Vaccine-induced immunity differs...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审


    authors: Chen Z,He Q

    更新日期:2017-04-03 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


    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

  • An overview of sipuleucel-T: autologous cellular immunotherapy for prostate cancer.

    abstract::Sipuleucel-T, the first autologous active cellular immunotherapy approved by the United States Food and Drug Administration, is designed to stimulate an immune response to prostate cancer. Sipuleucel-T is manufactured by culturing a patient's peripheral blood mononuclear cells (including antigen presenting cells) with...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审


    authors: Wesley JD,Whitmore J,Trager J,Sheikh N

    更新日期:2012-04-01 00:00:00

  • Immunological persistence in 5 y olds previously vaccinated with hexavalent DTPa-HBV-IPV/Hib at 3, 5, and 11 months of age.

    abstract::The combined diphtheria-tetanus-acellular pertussis-hepatitis B-poliomyelitis/Haemophilus influenza vaccine (DTPa-HBV-IPV/Hib: Infanrix™ hexa, GlaxoSmithKline Vaccines) is used for primary vaccination of infants in a range of schedules world-wide. Antibody persistence after 4 DTPa-HBV-IPV/Hib doses in the first 2 y of...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Silfverdal SA,Assudani D,Kuriyakose S,Van Der Meeren O

    更新日期:2014-01-01 00:00:00

  • Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine.

    abstract::Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive observational postlicensure safety surveillance study in Kaiser Permanente Southern California and Northern California to assess congenital anomaly and miscarriage...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Sy LS,Meyer KI,Klein NP,Chao C,Velicer C,Cheetham TC,Ackerson BK,Slezak JM,Takhar HS,Hansen J,Deosaransingh K,Liaw KL,Jacobsen SJ

    更新日期:2018-02-01 00:00:00

  • Q fever vaccination: Australian animal science and veterinary students' One Health perspectives on Q fever prevention.

    abstract::Unvaccinated animal science and veterinary students are at risk of Q fever, a vaccine-preventable zoonotic disease transmitted from animals to humans. We investigated students' perspectives on Q fever prevention using a One Health approach combining animal, human and environmental health. Animal science and veterinary...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Rahaman MR,Milazzo A,Marshall H,Chaber AL,Bi P

    更新日期:2020-11-12 00:00:00

  • Viral etiological causes of febrile seizures for respiratory pathogens (EFES Study).

    abstract:BACKGROUND:Febrile seizure is the most common childhood neurological disorder, is an important health problem with potential short- and long-term complications, also leading to economic burden and increased parental anxiety about fevers and seizures occurring in their children. There are no routine recommendation to de...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,多中心研究


    authors: Carman KB,Calik M,Karal Y,Isikay S,Kocak O,Ozcelik A,Yazar AS,Nuhoglu C,Sag C,Kilic O,Dinleyici M,Lacinel Gurlevik S,Yimenicioglu S,Ekici A,Perk P,Tosun A,Isik I,Yarar C,Arslantas D,Dinleyici EC

    更新日期:2019-01-01 00:00:00

  • Pollinex Quattro: an innovative four injections immunotherapy in allergic rhinitis.

    abstract::The prevalence of seasonal allergic rhinitis in the western world is high and increasing. Besides considerably affecting physical and psychosocial aspects of patients' lives, allergic rhinitis is often associated with allergic asthma and may aggravate this condition over time. Specific immunotherapy is currently the o...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Rosewich M,Lee D,Zielen S

    更新日期:2013-07-01 00:00:00

  • A reflection on invasive pneumococcal disease and pneumococcal conjugate vaccination coverage in children in Southern Europe (2009-2016).

    abstract::Higher-valent pneumococcal conjugate vaccines (PCVs) were licensed from 2009 in Europe; similar worldwide clinical effectiveness was observed for PCVs in routine use. Despite a proven medical need, PCV vaccination in Southern Europe remained suboptimal until 2015/16. We searched PubMed for manuscripts published betwee...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审


    authors: Moreira M,Castro O,Palmieri M,Efklidou S,Castagna S,Hoet B

    更新日期:2017-06-03 00:00:00

  • Efficacy and safety of a booster dose of the meningococcal A, C, W, Y-tetanus toxoid conjugate vaccine administered 10 years after primary vaccination and long-term persistence of tetanus toxoid conjugate or polysaccharide vaccine.

    abstract::A previous phase 3, randomized, multicenter study showed the immunogenicity of a primary vaccination of subjects aged 11 to 17 years with the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS). This extension study evaluate...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Quiambao B,Peyrani P,Li P,Cutler MW,Van Der Wielen M,Perez JL,Webber C

    更新日期:2020-06-02 00:00:00

  • Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials.

    abstract::The objective of this analysis was to compare the anti-HPV GMTs and their distribution after a 6-month or a 3-8 -y interval between two HPV vaccine doses. The results from two clinical trials, conducted by the same team in the same region, with serological assays performed at the same laboratory using the same ELISA m...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 临床试验,杂志文章


    authors: Gilca V,Sauvageau C,Panicker G,De Serres G,Schiller J,Ouakki M,Unger ER

    更新日期:2019-01-01 00:00:00

  • Human papillomavirus vaccination uptake: a longitudinal study showing ethnic differences in the influence of the intention-to-vaccinate among parent-daughter dyads.

    abstract:INTRODUCTION:It is unclear what role daughters play in the decision-making process regarding HPV vaccination. Therefore, we explored the impact of HPV vaccination intention among parents and their 12-13 year-old daughters on HPV vaccination uptake. METHODS:In February 2014 parents/guardians and their 12-13 year-old da...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Jongen VW,van der Loeff MFS,Boyd A,Petrignani M,Prins M,van der Wal M,Nielen A,de Melker H,Paulussen TGWM,Alberts CJ

    更新日期:2020-09-23 00:00:00

  • Preventive effects of influenza and pneumococcal vaccination in the elderly - results from a population-based retrospective cohort study.

    abstract::Influenza and pneumococcal vaccinations are recommended in the elderly to reduce life-threatening complications like sepsis. Protection may be reduced with increasing age. We aimed to assess the effectiveness of both vaccines in the elderly by performing a retrospective cohort study of 138,877 individuals aged ≥60 y i...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Rose N,Storch J,Mikolajetz A,Lehmann T,Reinhart K,Pletz MW,Forstner C,Vollmar HC,Freytag A,Fleischmann-Struzek C

    更新日期:2021-01-07 00:00:00

  • Trends involving monoclonal antibody (mAb) research and commercialization: A scientometric analysis of IMS Lifecycle R&D Focus Database (1980-2016).

    abstract::This article aims to explore the trends of monoclonal antibodies (mAbs) research and commercialization, mainly to examine the development trajectories by a contrastive exploration of successful and unsuccessful mAb. This work is based on two sets of R&D project reports, consisting of 517 discontinued mAb project repor...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Lai Y,Suo S,Wang R,Kong X,Hu Y,Tang D,Shi H,Chen S,Hu H

    更新日期:2018-04-03 00:00:00

  • Approaching a decade since HPV vaccine licensure: Racial and gender disparities in knowledge and awareness of HPV and HPV vaccine.

    abstract::Purpose: Gaps remain in the public's knowledge of the human papillomavirus (HPV). We assessed racial/ethnic and gender disparities in knowledge and awareness of HPV and the HPV vaccine among US adults. METHODS:Data from the Health Information National Trends Survey 4 Cycle 3 (September - December 2013) and Cycle 4 (A...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Adjei Boakye E,Tobo BB,Rojek RP,Mohammed KA,Geneus CJ,Osazuwa-Peters N

    更新日期:2017-11-02 00:00:00

  • Hepatitis A vaccination and its immunological and epidemiological long-term effects - a review of the evidence.

    abstract::Hepatitis A virus (HAV) infections continue to represent a significant disease burden causing approximately 200 million infections, 30 million symptomatic illnesses and 30,000 deaths each year. Effective and safe hepatitis A vaccines have been available since the early 1990s. Initially developed for individual prophyl...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Herzog C,Van Herck K,Van Damme P

    更新日期:2020-12-16 00:00:00

  • Cell-mediated immune responses to different formulations of a live-attenuated tetravalent dengue vaccine candidate in subjects living in dengue endemic and non-endemic regions.

    abstract::Three phase II randomized trials evaluated the safety/immunogenicity of two formulations of live-attenuated tetravalent dengue virus (TDEN) vaccine in dengue-endemic (Puerto Rico, Thailand) and non-endemic (US) regions (NCT00350337/NCT00370682/NCT00468858). We describe cell-mediated immune (CMI) responses; safety and ...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Moris P,Bauer KM,Currier JR,Friberg H,Eckels KH,Esquilin IO,Gibbons RV,Innis BL,Jarman RG,Simasathien S,Sun P,Thomas SJ,Watanaveeradej V

    更新日期:2019-01-01 00:00:00

  • Who should be prioritised for COVID-19 vaccination?

    abstract::The development of COVID-19 vaccines is occurring at a rapid pace, with the potential for a vaccine to be available within 6 months. So who should be prioritized for vaccination when in the first instance, there will be insufficient supply to meet demand? There is no doubt that health-care workers in all settings shou...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Russell FM,Greenwood B

    更新日期:2020-11-03 00:00:00

  • Small molecule drugs with immunomodulatory effects in cancer.

    abstract::Immunotherapy shows promise for positively changing the landscape of the management of many advanced solid tumors, including gastrointestinal (GI) malignancies. Many of these developments have been focused on vaccine-based, monoclonal antibody therapies and more recently, checkpoint inhibitors, although many small mol...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Murphy AG,Zheng L

    更新日期:2015-01-01 00:00:00

  • Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.

    abstract::Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicin...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Alicino C,Merlano C,Zappettini S,Schiaffino S,Della Luna G,Accardo C,Gasparini R,Durando P,Icardi G

    更新日期:2015-01-01 00:00:00

  • A new therapeutic potential for cancers: One CAR with 2 different engines!

    abstract::Tumor cells escape from immune recognition by several mechanisms such as down-regulating of MHC class I molecules, losing of tumor antigens, etc. The purpose of cancer immunotherapy is to robust or reconstruct the capacity of the immune system to recognize and kill tumor cells by overwhelming the mechanisms by which t...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 信件


    authors: Sheikhi A,Jafarzadeh A

    更新日期:2017-08-03 00:00:00

  • Allergen immunotherapy for allergic respiratory diseases.

    abstract::Allergen specific immunotherapy involves the repeated administration of allergen products in order to induce clinical and immunologic tolerance to the offending allergen. Immunotherapy is the only etiology-based treatment that has the potential for disease modification, as reflected by longterm remission following its...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,评审


    authors: Cappella A,Durham SR

    更新日期:2012-10-01 00:00:00

  • Economic analysis of the first 20 years of universal hepatitis B vaccination program in Italy: an a posteriori evaluation and forecast of future benefits.

    abstract::Italy was one of the first countries in the world to introduce a routine vaccination program against HBV for newborns and 12-y-old children. From a clinical point of view, such strategy was clearly successful. The objective of our study was to verify whether, at 20 y from its implementation, hepatitis B universal vacc...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Boccalini S,Taddei C,Ceccherini V,Bechini A,Levi M,Bartolozzi D,Bonanni P

    更新日期:2013-05-01 00:00:00

  • The burden of infant group B streptococcal infections in Ontario: Analysis of administrative data to estimate the potential benefits of new vaccines.

    abstract::Group B streptococcus (GBS) is a leading bacterial cause of neonatal sepsis and meningitis in many countries as well as an important cause of disease in pregnant women. Currently, serotype-specific conjugate vaccines are being developed. We conducted an epidemiological analysis of health administrative data to estimat...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Hartley J,Li Y,Kunkel L,Crowcroft NS

    更新日期:2019-01-01 00:00:00

  • Parental vaccine attitudes, beliefs, and practices: initial evidence in California after a vaccine policy change.

    abstract::Senate Bill 277 (SB277) eliminated nonmedical exemptions for school-entry vaccines in California, but the impact of parental vaccine knowledge, attitudes, and beliefs on vaccine decision-making has not been extensively examined within the post-SB277 context. This study generates preliminary understanding and discussio...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章


    authors: Holroyd TA,Howa AC,Delamater PL,Klein NP,Buttenheim AM,Limaye RJ,Proveaux TM,Omer SB,Salmon DA

    更新日期:2020-11-24 00:00:00

  • A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults.

    abstract::Neisseria meningitidis serogroup B (MnB) is a significant cause of invasive meningococcal disease, but no broadly protective vaccine is yet approved. We assessed the safety and immunogenicity of a bivalent MnB vaccine composed of lipidated subfamily A and B variants of recombinant LP2086 (rLP2086, also known as factor...

    journal_title:Human vaccines & immunotherapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Sheldon EA,Schwartz H,Jiang Q,Giardina PC,Perez JL

    更新日期:2012-07-01 00:00:00