K. Tabynov et al., J <strong>Vaccines</strong> Vaccin <strong>2013</strong>, 4:5http://dx.doi.org/10.4172/2157-7560.S1.0173 rd International Conference on<strong>Vaccines</strong> & VaccinationJuly 29-31, <strong>2013</strong> Embassy Suites Las Vegas, NV, USASafety and immunogenicity of an inactivated whole-virion chromatographic vaccine withaluminum against influenza А (H1N1) pdm09: A randomized, blinded, dose-dependentplacebo-controlled clinical studyK. Tabynov 1 , A. Sansyzbay 1 , O. Kiselev 2 , B. Khairullin 1 , Zh. Kydyrbayev 1 , N. Sandybayev 1 , M. Kassenov 1 and M. Stukova 21Research Institute for Biological Safety Problems (RIBSP), Gvardeiskiy, Kazakhstan2Research Institute of Influenza, St. Petersburg, Russian FederationBackground: The pandemic influenza A/H1N1 pdm09 emerged in 2009 and led to high demand for influenza vaccines,highlighting the limited vaccine manufacturing capacity world-wide. To meet the needs of Kazakhstan for an effective vaccineagainst pandemic influenza, the Research Institute for Biological Safety Problems developed an inactivated whole-virionchromatographic vaccine with aluminum (trade name Refluvac). This paper presents the results of a clinical Phase I single-usestudy of the vaccine in healthy volunteers aged 18-60 years.Materials and methods: The study was conducted at the clinical facilities of the Research Institute of Influenza (RussianFederation). Number of volunteers enrolled in the study-54 people, including those who receive three doses (3.75, 7.5 or 15.0mcg of hemagglutinin [HA]) of the vaccine-36 people (to 12 people in each dose) and a placebo-18 people. Antibody response(seroconversion and seroprotection rates, geometric mean titer [GMT], seroconversion factors) was determined using thehemagglutination inhibition (HAI) assay. Cellular immune response was assayed using the index of stimulation of peripheralblood mononuclear cells (PBMCs) and the production of cytokines by antigen supernatant-stimulated cells. Reactogenicity andsafety were assessed by monitoring adverse reactions (local and systemic reactions), physical examinations, monitoring of vitalsymptoms and laboratory tests (general and biochemical blood tests, Ig E, urinalysis). The study was conducted in accordancewith protocol VRK-I-00-01/2010 approved by the Federal Service on Surveillance in Healthcare and Social Development of theMinistry of Health and Social Development of the Russian Federation.Results: Volunteers vaccinated with the vaccine at a dose of 3.75 mcg HA adverse events related to vaccination were not observed.Volunteers vaccinated with the vaccine at a dose of 7.5 mcg HA did not have any systemic reactions related to the vaccination.Weak local reactions, presenting as pain and discomfort at the injection site, were observed in 3 of the 12 (25%) volunteersvaccinated at a dose of 7.5 mcg HA; these reactions were not accompanied by the development of hyperemia or infiltrates, weretransient (lasted no more than 2 days), and disappeared without medication. Among the volunteers vaccinated with the vaccine ata dose of 15.0 mcg HA, one medium systemic reaction was observed as an increase in temperature up to 37.8°C after 6 hours postvaccination (PV). Weak local reactions, presenting as pain and discomfort at the injection site were not observed in volunteersvaccinated at a dose of 15.0 mcg HA. Clinical and laboratory examinations of the volunteers on days 7 and 21 PV revealed thatthe morphological and biochemical parameters of peripheral blood, including the total level of IgE, did not significantly alterfrom normal physiological values (all p>0.05). Vaccination had no adverse effect on electrocardiogram (ECG) data PV, as theECG data for all volunteers remained similar to the baseline values. In terms of rating the immunogenic activity of the vaccine,83.3% of the volunteers vaccinated at a dose of 3.75 mcg HA had a 4-fold seroconversion rate; the seroprotection rate was 75%, themultiplicity of growth of the antibody titer was 10.7 and the GMT was 53.4. In the group vaccinated at a dose of 7.5 mcg HA, 100%of the volunteers had a 4-fold seroconversion rate; the seroprotection rate was 75%, the multiplicity of growth of the antibodytiter reached 32.0, and the GMT was 160.0. Using a high dose of the vaccine (15.0 mcg HA), an increase in the proportion ofpeople (from 75% to 83%) with protective antibody titers, but increase the GMT and the multiplicity of growth of the antibodytiter in this group compared to group, which vaccinated at a dose of 7.5 mcg HA was not observed (p>0.05). Vaccination led tothe formation of a cellular immune response, which was polarized towards Th-1 production.Conclusions: This Phase I clinical study of the Refluvac vaccine at doses of 3.75, 7.5 or 15.0 mcg HA in healthy volunteers aged18-60 years-old indicates the antibody can induce pronounced immunogenicity, is well tolerated, has a low reactogenicity, is safe,and leads to the formation of a cellular immune response.tabynov_81@mail.ruJ <strong>Vaccines</strong> Vaccin <strong>2013</strong>ISSN: 2157-7560, JVV an open access journal<strong>Vaccines</strong>-<strong>2013</strong>July 29-31, <strong>2013</strong>Volume 4 Issue 5Page 108
Xiao-Yong Fan et al., J <strong>Vaccines</strong> Vaccin <strong>2013</strong>, 4:5http://dx.doi.org/10.4172/2157-7560.S1.0173 rd International Conference on<strong>Vaccines</strong> & VaccinationJuly 29-31, <strong>2013</strong> Embassy Suites Las Vegas, NV, USAEnhanced protective immunity against Mycobacterium tuberculosis afforded by BCG prime-DNA boost regimen correlates with increased IL-2-producing CD4 T cell frequencyXiao-Yong Fan 1,2 , Han Kang 1,2 , Qing Yuan 1 , Hui Ma 1 , De-Ping Han 1 , Kang Wu 1 and Douglas B. Lowrie 11Shanghai Public Health Clinical Center Affiliated to Fudan University, China2Key Laboratory of Medical Molecular Virology, Shanghai Medical College, Fudan University, ChinaThe development of improved vaccines and vaccination strategies against Mycobacterium tuberculosis has been hindered bya limited understanding of the immune correlates of anti-tuberculosis protective immunity. Simple measurement of IFN-frequency or production per se does not provide adequate prediction of immune protection. In this study, we examined therelationship between T cell immune responses and protection conferred by the heterologous vaccination strategy, BCG prime-Ag85A DNA boost (B/D), in a mouse model of pulmonary tuberculosis. The results demonstrated that mice vaccinated with theB/D regimen had a significantly reduced bacillary load compared to BCG-vaccinated mice, and the CFU reduction was associatedwith decreased pathology and lower levels of inflammatory cytokines in the infected lungs. Further analysis of immunogenicityshowed that the superior protection afforded by the B/D regimen correlated with significantly increased frequency of IL-2-producing CD4 T cells and increased IL-2 production when measured as integrated mean fluorescence intensity (iMFI) valuepost-vaccination. These data suggest that measurement of elevated IL-2 production or frequency of IL-2-producing CD4 T cellscan predict vaccine efficacy, and add to the accumulating body of evidence suggesting that BCG vaccination in prime-booststrategies may be a useful tool for the control of M. tb infection.Keywords: Protective immunity; Prime-boost; DNA vaccine; Multifunctional T cell; IL-2; Mycobacterium tuberculosis.BiographyXiao-Yong Fan, Ph.D. Associate Professor, Young PI. He was born in April 1977, was awarded to be Shanghai Rising-Star (A) programmed byShanghai Science and Technology Commission in 2009 and got the tracking support in 2012, and was promoted atypically to be Master’s tutorof Pathogeny Biology in Fudan University in Jan 2011. In Sep 2005, Dr. Fan entered to Department of Microbiology, Fudan University to pursuehis doctorate under supervision of Prof. Guo-Ping Zhao, academician of Chinese Academy of Sciences. After graduation, Dr. Fan joined into theDepartment of Scientifi c Research, Shanghai Public Health Clinical Center since Sep, 2008 as assistant professor fi rstly, and he was promoted asassociate professor soon and began to establish Tuberculosis laboratory on infection and immunity in 2011. At present, Dr Fan’s research interestsfocus on infection and immunity, and vaccine development on Tuberculosis.xyfan008@fudan.edu.cnJ <strong>Vaccines</strong> Vaccin <strong>2013</strong>ISSN: 2157-7560, JVV an open access journal<strong>Vaccines</strong>-<strong>2013</strong>July 29-31, <strong>2013</strong>Volume 4 Issue 5Page 109
- Page 1 and 2:
111 th OMICS Group ConferenceJuly 2
- Page 3 and 4:
Medical SciencesISSNAddiction Resea
- Page 5 and 6:
Impact Factors (IF) and Index Coper
- Page 7 and 8:
111 th OMICS Group Conference3 rd I
- Page 9 and 10:
Journal of Clinical & Cellular Immu
- Page 11 and 12:
111 th OMICS Group Conference3 rd I
- Page 13 and 14:
111 th OMICS Group Conference3 rd I
- Page 15 and 16:
Clinical Microbiology-2013OMICS Gro
- Page 17 and 18:
Immunology Summit-2013OMICS Group i
- Page 19 and 20:
Probiotics-2013OMICS Group is organ
- Page 21 and 22:
Virology-2013OMICS Group is organiz
- Page 23 and 24:
111 th OMICS Group Conference3 rd I
- Page 25 and 26:
Because of heightened awareness of
- Page 27 and 28:
111 th OMICS Group Conference3 rd I
- Page 29 and 30:
111 th OMICS Group Conference3 rd I
- Page 31 and 32:
111 th OMICS Group Conference3 rd I
- Page 33 and 34:
Ara Hovanessian, J Vaccines Vaccin
- Page 35 and 36:
Nikolai Petrovsky, J Vaccines Vacci
- Page 37 and 38:
111 th OMICS Group Conference3 rd I
- Page 39 and 40:
Robert E. Sievers et al., J Vaccine
- Page 41 and 42:
Xiao-Qing Wei, J Vaccines Vaccin 20
- Page 43 and 44:
Campbell Bunce, J Vaccines Vaccin 2
- Page 45 and 46:
Hong Xin, J Vaccines Vaccin 2013, 4
- Page 47 and 48:
Diane Longo et al., J Vaccines Vacc
- Page 49 and 50:
Track 33: Novel Approaches in Desig
- Page 51 and 52:
Takashi Kei Kishimoto, J Vaccines V
- Page 53 and 54:
Benjamin Petsch, J Vaccines Vaccin
- Page 55 and 56:
A. Bennett Jenson et al., J Vaccine
- Page 57 and 58: Milan Raska et al., J Vaccines Vacc
- Page 59 and 60: Muhammad Ali A. Shah et al., J Vacc
- Page 61 and 62: Track 44: Vaccines against Infectio
- Page 63 and 64: Haval Shirwan, J Vaccines Vaccin 20
- Page 65 and 66: Rainer Fischer, J Vaccines Vaccin 2
- Page 67 and 68: Alwyn Rapose, J Vaccines Vaccin 201
- Page 69 and 70: Saroj Basak, J Vaccines Vaccin 2013
- Page 71 and 72: Gisela Gonzalez, J Vaccines Vaccin
- Page 73 and 74: Young Research ForumSession ChairPe
- Page 75 and 76: Humberto Hernandez et al., J Vaccin
- Page 77 and 78: Nisha Nair et al., J Vaccines Vacci
- Page 79 and 80: Leow Yee et al., J Vaccines Vaccin
- Page 81 and 82: Kaissar Tabynov et al., J Vaccines
- Page 83 and 84: Teena Mohan et al., J Vaccines Vacc
- Page 85 and 86: Track 5 & 95: Manufacturing, Produc
- Page 87 and 88: Graham Clarke, J Vaccines Vaccin 20
- Page 89 and 90: Obradovic Zarema et al., J Vaccines
- Page 91 and 92: Abdur Razzaque Sarker et al., J Vac
- Page 93 and 94: Omer Qutaiba B. Al-lela et al., J V
- Page 95 and 96: 111 th OMICS Group Conference3 rd I
- Page 97 and 98: Regina Heidenreich et al., J Vaccin
- Page 99 and 100: Leow Y et al., J Vaccines Vaccin 20
- Page 101 and 102: Zafer Kurugol et al., J Vaccines Va
- Page 103 and 104: Ates Kara et al., J Vaccines Vaccin
- Page 105 and 106: Yurong Tan et al., J Vaccines Vacci
- Page 107: Deryabin P.N. et al., J Vaccines Va
- Page 111 and 112: Byung Chul Kim et al., J Vaccines V
- Page 113 and 114: STS. Chitradevi et al., J Vaccines
- Page 115 and 116: Yan Liang et al., J Vaccines Vaccin
- Page 117 and 118: 111 th OMICS Group Conference3 rd I
- Page 119 and 120: Afshineh Latifynia et al., J Vaccin
- Page 121 and 122: Hemanta Koley et al., J Vaccines Va
- Page 123 and 124: Aleksandar Masic et al., J Vaccines
- Page 125 and 126: Hassen Mamo, J Vaccines Vaccin 2013
- Page 127 and 128: Oladipo Aina et al., J Vaccines Vac
- Page 129 and 130: Aiswariya Chidambaram, J Vaccines V
- Page 131 and 132: Birhanu Hurisa et al., J Vaccines V
- Page 133 and 134: Ghaffarifar F et al., J Vaccines Va
- Page 135 and 136: Mathan Periasamy et al., J Vaccines
- Page 137 and 138: Rania Abdel Hay, J Vaccines Vaccin
- Page 139 and 140: Samuel Teshome, J Vaccines Vaccin 2
- Page 141 and 142: 111 th OMICS Group Conference3 rd I
- Page 143 and 144: Birhanu Hurisa et al., J Vaccines V
- Page 145 and 146: Dhrubajyoti Nag, J Vaccines Vaccin
- Page 147 and 148: Belachew Etana et al., J Vaccines V
- Page 149 and 150: Fatemeh Ghaffarifar et al., J Vacci
- Page 151 and 152: Moustafa A.F. Abbas et al., J Vacci
- Page 153 and 154: Prerna Chaudhary, J Vaccines Vaccin
- Page 155 and 156: Sandeepkumar R. Chauhan et al., J V
- Page 157 and 158: Veronica Rainone et al., J Vaccines
- Page 159 and 160:
Page 159
- Page 161 and 162:
Previous111 th OMICS Group Conferen
- Page 163 and 164:
PreviousWorld Congress and Expo onB