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  1. Article ; Online: Comparative frequency of specified adverse events following Vero cell culture-derived Japanese encephalitis and Vi capsular polysaccharide typhoid vaccines in U.S. military personnel, July 2011-August 2019.

    Seshadri, Srihari / Martin, Stacey W / Hills, Susan L / Collins, Limone C

    Vaccine

    2023  Volume 41, Issue 9, Page(s) 1537–1540

    Abstract: Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and ... ...

    Abstract Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC; Ixiaro) was approved in the United States in 2009. The previous JE vaccine, an inactivated mouse brain-derived vaccine, had been associated with rare, but serious, allergic and neurologic adverse events (AE). Studies and AE surveillance have supported JE-VC's safety, but one evaluation among military personnel found elevated hypersensitivity and neurologic AE rates. However, co-administration of multiple vaccines to some personnel might have affected results. We retrospectively compared rates of hypersensitivity and neurologic AEs within 28 days following vaccination of military personnel with JE-VC or parenteral Vi capsular polysaccharide typhoid vaccine administered without other vaccines from July 1, 2011, through August 31, 2019. Rates of most events were similar between the vaccines. Only delayed hypersensitivity reactions occurred more frequently following JE-VC (rate ratio: 4.2, 95 % CI 1.2-15.3; p = 0.03), but rates were low for both vaccines. These results support JE-VC's safety.
    MeSH term(s) Animals ; Chlorocebus aethiops ; Mice ; United States ; Humans ; Encephalitis, Japanese/prevention & control ; Typhoid-Paratyphoid Vaccines ; Military Personnel ; Retrospective Studies ; Japanese Encephalitis Vaccines ; Vero Cells ; Hypersensitivity ; Vaccines, Inactivated ; Polysaccharides ; Cell Culture Techniques
    Chemical Substances Typhoid-Paratyphoid Vaccines ; Japanese Encephalitis Vaccines ; Vaccines, Inactivated ; Polysaccharides
    Language English
    Publishing date 2023-01-30
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2023.01.061
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Trends in cigarette smoking and obesity in Appalachian Kentucky.

    Schoenberg, Nancy E / Huang, Bin / Seshadri, Srihari / Tucker, Thomas C

    Southern medical journal

    2015  Volume 108, Issue 3, Page(s) 170–177

    Abstract: Objectives: The southern region of the United States, particularly central and southern Appalachia, has long been identified as an area of health inequities. An updated and more complete understanding of the association among the leading risk factors ... ...

    Abstract Objectives: The southern region of the United States, particularly central and southern Appalachia, has long been identified as an area of health inequities. An updated and more complete understanding of the association among the leading risk factors for such health inequities allows researchers, clinicians, and policymakers to focus their efforts on the most effective strategies to minimize these risks.
    Methods: Using the most recent survey data from the Behavioral Risk Factor Surveillance System, we examined 10-year trends in rates of cigarette smoking and obesity in Appalachian Kentucky, comparing these trends with national and non-Appalachian Kentucky rates.
    Results: Women and men from Appalachian Kentucky smoke cigarettes at rates 1.8 times and 1.6 times higher, respectively, than their national counterparts. Although rates of smoking in Appalachian Kentucky, non-Appalachian Kentucky, and the United States have decreased, such decreases among Appalachian Kentucky women have been minimal. Adding to these concerning trends, obesity rates in Appalachian adults are much higher than in non-Appalachian Kentucky or the United States overall, although Appalachian Kentucky smokers are less likely to be obese than nonsmokers. Low socioeconomic status and impeded access to health care characterize the Appalachian communities in which these risk behaviors occur and likely account for the prevalence of these most risky behaviors.
    Conclusions: A continuum of approaches to address smoking and obesity is warranted. Such approaches range from ensuring access to smoking cessation programs to implementing community- and state-level policies to curb smoking and unhealthy energy balance (eg, smoke-free policies and increases in tobacco and "junk food" taxes) and culturally appropriate individual-level interventions (evidence-based smoking cessation and weight-loss programming).
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Appalachian Region/epidemiology ; Female ; Health Status Disparities ; Health Surveys ; Humans ; Kentucky/epidemiology ; Logistic Models ; Male ; Middle Aged ; Obesity/epidemiology ; Obesity/etiology ; Public Health Surveillance ; Risk Factors ; Rural Health/statistics & numerical data ; Smoking/epidemiology ; Young Adult
    Language English
    Publishing date 2015-03
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 185329-6
    ISSN 1541-8243 ; 0038-4348
    ISSN (online) 1541-8243
    ISSN 0038-4348
    DOI 10.14423/SMJ.0000000000000245
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011-July 2018.

    McNeil, Michael M / Paradowska-Stankiewicz, Iwona / Miller, Elaine R / Marquez, Paige L / Seshadri, Srihari / Collins, Limone C / Cano, Maria V

    Vaccine

    2019  Volume 37, Issue 44, Page(s) 6760–6767

    Abstract: Background: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally ...

    Abstract Background: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS).
    Methods: We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination.
    Results: During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17-32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%).
    Conclusions: The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile.
    MeSH term(s) Adenoviridae/classification ; Adenoviridae/immunology ; Adenoviridae Infections/prevention & control ; Adenovirus Vaccines/administration & dosage ; Adenovirus Vaccines/adverse effects ; Adenovirus Vaccines/immunology ; Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Anaphylaxis/epidemiology ; Anaphylaxis/prevention & control ; Databases, Factual ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Drug-Related Side Effects and Adverse Reactions/history ; Female ; History, 21st Century ; Humans ; Male ; Pregnancy ; Risk Assessment ; Risk Factors ; United States/epidemiology ; Young Adult
    Chemical Substances Adenovirus Vaccines
    Language English
    Publishing date 2019-09-20
    Publishing country Netherlands
    Document type Historical Article ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2019.08.087
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

    McNeil, Michael M / Cano, Maria V / Collins, Limone C / Marquez, Paige L / Miller, Elaine R / Paradowska-Stankiewicz, Iwona / Seshadri, Srihari

    Vaccine. 2019 Oct. 16, v. 37, no. 44

    2019  

    Abstract: In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered ...

    Abstract In March 2011, the U.S. Food and Drug Administration licensed adenovirus type 4 and type 7 vaccine, live, oral (Barr Labs, Inc.) (adenovirus vaccine) for use in military personnel 17 through 50 years of age. The vaccine was first universally administered to U.S. military recruits in October 2011. We investigated adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS).We searched the VAERS database for U.S. reports among persons who received adenovirus vaccine during October 2011 through July 2018 including participants in a military observational study. We reviewed all serious reports and accompanying medical records. We compared the proportion of serious reports in a proxy military recruit population and reviewed all reports of suspected allergic reactions following adenovirus vaccination.During the analytic period, VAERS received 100 reports following adenovirus vaccination; 39 (39%) were classified as serious and of these, 17 (44%) were from the observational study. One death was reported. Males accounted for 72% of reports. Median age of vaccinees was 19 years (range 17–32). The most frequently reported serious AEs were Guillain Barré syndrome (GBS) (n = 12) and anaphylaxis (n = 8); of these, two GBS and all the anaphylaxis reports were reported in the observational study. Reports documented concurrent receipt of multiple other vaccines (95%) and penicillin G (IM Pen G) or other antibiotics (50%).The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39% vs 18%); however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine’s safety profile.
    Keywords Adenoviridae ; anaphylaxis ; benzylpenicillin ; databases ; death ; Guillain-Barre Syndrome ; males ; medical records ; military personnel ; observational studies ; vaccination ; vaccines ; United States
    Language English
    Dates of publication 2019-1016
    Size p. 6760-6767.
    Publishing place Elsevier Ltd
    Document type Article
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2019.08.087
    Database NAL-Catalogue (AGRICOLA)

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  5. Article ; Online: Comparison of A(H3N2) Neutralizing Antibody Responses Elicited by 2018-2019 Season Quadrivalent Influenza Vaccines Derived from Eggs, Cells, and Recombinant Hemagglutinin.

    Wang, Wei / Alvarado-Facundo, Esmeralda / Vassell, Russell / Collins, Limone / Colombo, Rhonda E / Ganesan, Anuradha / Geaney, Casey / Hrncir, David / Lalani, Tahaniyat / Markelz, Ana Elizabeth / Maves, Ryan C / McClenathan, Bruce / Mende, Katrin / Richard, Stephanie A / Schofield, Christina / Seshadri, Srihari / Spooner, Christina / Utz, Gregory C / Warkentien, Tyler E /
    Levine, Min / Coles, Christian L / Burgess, Timothy H / Eichelberger, Maryna / Weiss, Carol D

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2020  Volume 73, Issue 11, Page(s) e4312–e4320

    Abstract: Background: Low vaccine effectiveness against A(H3N2) influenza in seasons with little antigenic drift has been attributed to substitutions in hemagglutinin (HA) acquired during vaccine virus propagation in eggs. Clinical trials comparing recombinant HA ...

    Abstract Background: Low vaccine effectiveness against A(H3N2) influenza in seasons with little antigenic drift has been attributed to substitutions in hemagglutinin (HA) acquired during vaccine virus propagation in eggs. Clinical trials comparing recombinant HA vaccine (rHA) and cell-derived inactivated influenza vaccine (IIV) to egg-derived IIVs provide opportunities to assess how egg-adaptive substitutions influence HA immunogenicity.
    Methods: Neutralization titers in pre- and postimmunization sera from 133 adults immunized with 1 of 3 types of influenza vaccines in a randomized, open-label trial during the 2018-2019 influenza season were measured against egg- and cell-derived A/Singapore/INFIMH-16-0019/2016-like and circulating A(H3N2) influenza viruses using HA pseudoviruses.
    Results: All vaccines elicited neutralizing antibodies to all H3 vaccine antigens, but the rHA vaccine elicited the highest titers and seroconversion rates against all strains tested. Egg- and cell-derived IIVs elicited responses similar to each other. Preimmunization titers against H3 HA pseudoviruses containing egg-adaptive substitutions T160K and L194P were high, but lower against H3 HA pseudoviruses without those substitutions. All vaccines boosted neutralization titers against HA pseudoviruses with egg-adaptive substitutions, but poorly neutralized wild-type 2019-2020 A/Kansas/14/2017 (H3N2) HA pseudoviruses.
    Conclusion: Egg- and cell-derived 2018-2019 season influenza vaccines elicited similar neutralization titers and response rates, indicating that the cell-derived vaccine did not improve immunogenicity against the A(H3N2) viruses. The higher responses after rHA vaccination may be due to its higher HA content. All vaccines boosted titers to HA with egg-adaptive substitutions, suggesting boosting from past antigens or better exposure of HA epitopes. Studies comparing immunogenicity and effectiveness of different influenza vaccines across many seasons are needed.
    MeSH term(s) Adult ; Antibodies, Neutralizing ; Antibodies, Viral ; Hemagglutinin Glycoproteins, Influenza Virus/genetics ; Hemagglutinins ; Humans ; Influenza A Virus, H3N2 Subtype ; Influenza Vaccines ; Influenza, Human ; Seasons
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; Hemagglutinin Glycoproteins, Influenza Virus ; Hemagglutinins ; Influenza Vaccines
    Language English
    Publishing date 2020-09-08
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciaa1352
    Database MEDical Literature Analysis and Retrieval System OnLINE

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