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  • 1
    Language: English
    In: The Journal of infectious diseases, 01 September 2013, Vol.208(5), pp.728-38
    Description: Nontypeable Haemophilus influenzae (NTHi) exclusively infects humans, causing significant numbers of upper respiratory tract infections. The goal of this study was to develop a safe experimental human model of NTHi nasopharyngeal colonization. A novel streptomycin-resistant strain of NTHi was developed, and 15 subjects were inoculated in an adaptive-design phase I trial to rapidly identify colonizing doses of NTHi. Bayesian analysis was used to estimate the human colonizing dose 50 and 90 (HCD50 and HCD90, respectively). Side effects and immunological responses to whole-cell sialylated NTHi were measured. Nine subjects were colonized and tolerated colonization well. Immunological analyses demonstrated that 7 colonized subjects and 0 noncolonized subjects had a 4-fold rise in serum levels of immunoglobulin A, immunoglobulin M, or immunoglobulin G. Preexisting immunity to whole-cell NTHi did not predict success or failure of colonization. The statistical design incorporated a slow escalation to higher dose levels. HCD50 and HCD90 Bayesian estimates were identified as approximately 2000 and 150 000 colony-forming units, respectively; credible interval estimates were broad. This study provides a potential platform for early proof of concept studies for NTHi vaccines, as well as a way to evaluate bacterial factors associated with colonization.
    Keywords: Bayesian Analysis ; Haemophilus Influenzae ; Adaptive Design ; Nasopharyngeal Colonization ; Respiratory Pathogens ; Upper Respiratory Tract ; Models, Theoretical ; Carrier State -- Immunology ; Haemophilus Infections -- Immunology ; Haemophilus Influenzae -- Growth & Development
    ISSN: 00221899
    E-ISSN: 1537-6613
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  • 2
    Language: English
    In: Vaccine, 13 May 2014, Vol.32(23), pp.2732-2739
    Description: Reintroduction of Variola major as an agent of bioterrorism remains a concern. Time to seroconversion and plaque reduction neutralizing antibody titers (PRNT) of 1 or 2 standard doses (SD) were compared to a single high dose (HD) of modified vaccinia Ankara (MVA). Ninety subjects were randomized 1:1 to receive 1 HD or 2 SD of MVA subcutaneously on Days 0 and 28 in a placebo-controlled trial. Serum was collected for PRNT and ELISA. Subjects were followed for safety for the entire study. The HD was well-tolerated. Using Bavarian Nordic's ELISA, subjects in both groups achieved seroconversion by Study Day 15 (HD) and Day 28 (SD). Before second vaccination, the hazard rate of seroconverting for the HD group was 1.7 times the SD group with a median time for seroconversion of 14 days for both groups. The peak titer of one HD vaccine was superior to one dose of SD vaccine but inferior to the peak titer after the second dose of the SD vaccination regimen. Using Saint Louis University's PRNT, peak titers were 95.8 and 65.2 for the HD and SD groups, respectively, prior to second vaccination. Non-inferiority of the SD group was not established. The proportions of positives were 93.3% (42/45) and 82.2% (37/45) for the HD and SD groups, respectively. The peak titer after two standard doses was superior to that of the HD. HD MVA was safe and well-tolerated. While the hazard rate for seroconverting was significantly higher in the HD group before second dose, the effect was small as the median time to seroconversion was identical. When comparing PRNT, non-inferiority of one SD was not established and the peak titers were low for both groups. The HD peak response was inferior to the standard two-dose regimen response based on ELISA and PRNT.
    Keywords: Mva ; Imvamune ; Vaccine ; ELISA ; Plaque Reduction Neutralizing Antibody ; Smallpox ; Variola ; Medicine ; Biology ; Veterinary Medicine ; Pharmacy, Therapeutics, & Pharmacology
    ISSN: 0264-410X
    E-ISSN: 1873-2518
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  • 3
    Language: English
    In: The Journal of infectious diseases, 15 September 2012, Vol.206(6), pp.828-37
    Description: Administering 2 separate vaccines for seasonal and pandemic influenza was necessary in 2009. Therefore, we conducted a randomized trial of monovalent 2009 H1N1 influenza vaccine (2009 H1N1 vaccine) and seasonal trivalent inactivated influenza vaccine (TIV; split virion) given sequentially or concurrently in previously vaccinated children. Children randomized to 4 study groups and stratified by age received 1 dose of seasonal TIV and 2 doses of 2009 H1N1 vaccine in 1 of 4 combinations. Injections were given at 21-day intervals and serum samples for hemagglutination inhibition antibody responses were obtained prior to and 21 days after each vaccination. Reactogenicity and adverse events were monitored. All combinations of vaccines were safe in the 531 children enrolled. Generally, 1 dose of 2009 H1N1 vaccine and 1 dose of TIV, regardless of sequence or concurrency of administration, was immunogenic in children ≥ 10 years of age; children 〈10 years of age required 2 doses of 2009 H1N1 vaccine. Vaccines were generally well tolerated. The immune responses to 2009 H1N1 vaccine were adequate regardless of the sequence of vaccination in all age groups but the sequence affected titers to TIV antigens. Two doses of 2009 H1N1 vaccine were required to achieve a protective immune response in children 〈10 years of age. NCT00943202.
    Keywords: Immunization Schedule ; Influenza A Virus, H1n1 Subtype -- Immunology ; Influenza A Virus, H3n2 Subtype -- Immunology ; Influenza B Virus -- Immunology ; Influenza Vaccines -- Immunology ; Influenza, Human -- Prevention & Control
    ISSN: 00221899
    E-ISSN: 1537-6613
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  • 4
    Language: English
    In: The Journal of infectious diseases, 01 March 2012, Vol.205(5), pp.703-12
    Description: The immunogenicity of a high hemagglutinin (HA) dose or a second dose of influenza vaccine in human immunodeficiency virus (HIV)-infected individuals has not been fully explored. One hundered ninety-two HIV-infected individuals aged 18-64 years were stratified by CD4 cell count (〈200 cells/mL or ≥200 cells/mL) and randomized to receive 2 doses of 15 μg or 30 μg HA 2009 H1N1 vaccine 21 days apart. Hemagglutination inhibition (HAI) and microneutralization (MN) antibodies were measured on days 0, 10, 21, 31, 42, and 201. Recipients of 30 μg HA had significantly higher HAI geometric mean titers (GMTs), compared with recipients of 15 μg HA on days 10 (139.0 vs 51.9; P = .01), 21 (106.7 vs 51.9; P = .001), and 31 (130.0 vs 73.7; P = .03) but not on days 42 (91.8 vs 61.6; P = .11) and 201 (43.0 vs 27.0; P = .08). When analyzed by CD4 cell count stratum, HAI GMTs were significantly higher among 30 μg HA recipients than among 15 μg HA in the CD4 cell count 〈200 cells/mL stratum on days 21 and 31 and the MN GMTs on days 10, 21, 31, and 42 (P 〈 .05). In the CD4 cell count ≥200 cells/mL stratum, MN GMTs were significantly higher among recipients of 30 μg HA than among recipients of 15 μg HA on day 10 (P = .03). Increasing the HA dose of the 2009 H1N1 vaccine improves the vaccine's immunogenicity in HIV-infected individuals. NCT00992433.
    Keywords: Antigens, Viral -- Immunology ; HIV Infections -- Immunology ; Hemagglutinins -- Immunology ; Influenza A Virus, H1n1 Subtype -- Immunology ; Influenza Vaccines -- Administration & Dosage
    ISSN: 00221899
    E-ISSN: 1537-6613
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  • 5
    Language: English
    In: The Journal of infectious diseases, 15 August 2015, Vol.212(4), pp.525-30
    Description: Influenza A(H5N1) vaccination strategies that improve the speed of the immunological response and cross-clade protection are desired. We compared the immunogenicity of a single 15-μg or 90-μg dose of A/H5N1/Indonesia/05/05 (clade 2) vaccine in adults who were previously primed with A/H5N1/Vietnam/1203/2004 (clade 1) vaccine. High-dose vaccine resulted in significantly higher titers to both clade 1 and 2 antigens. Clade 2 titers were unaffected by the previous dose of clade 1 vaccine. Low-dose priming with a mismatched pandemic influenza A(H5N1) vaccine would improve the rapidity, magnitude, and cross-reactivity of the immunological response following a single high-dose, unadjuvanted, pandemic vaccine.
    Keywords: H5n1 ; Influenza ; Prime-Boost ; Vaccine ; Influenza A Virus, H5n1 Subtype -- Immunology ; Influenza Vaccines -- Adverse Effects ; Influenza, Human -- Prevention & Control
    ISSN: 00221899
    E-ISSN: 1537-6613
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  • 6
    Language: English
    In: Journal of Infectious Diseases, Sept 1, 2013, Vol.208(5), p.720(8)
    Keywords: Haemophilus Influenzae -- Genetic Aspects ; Haemophilus Influenzae -- Research ; Genetic Variation -- Research
    ISSN: 0022-1899
    Source: Cengage Learning, Inc.
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  • 7
    Language: English
    In: The Journal of infectious diseases, 15 August 2015, Vol.212(4), pp.552-61
    Description: Variant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed. Healthy adults received 2 doses of subvirion H3N2v vaccine (15 µg of hemagglutinin/dose) 21 days apart in this open-label trial. Serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody (Ab) titers were measured before and 8 and 21 days after each dose. Memory B-cell (MBC) responses were assessed. Vaccine was well tolerated. A total of 40% of subjects had an HAI Ab titer of ≥40 before vaccination. Eight-seven percent (95% confidence interval [CI], 79%-93%) and 73% (95% CI, 63%-81%) of subjects 18-64 years old (98 subjects) and ≥65 years old (90 subjects), respectively, had an HAI titer of ≥40 21 days after dose 1 (P = .01); 51% (95% CI, 41%-61%) and 52% (95% CI, 41%-62%) of younger and older subjects, respectively, developed ≥4-fold rises in titer (P = not significant). Neut Ab response patterns were similar. Geometric mean titers were higher in younger subjects. Dose 2 provided no significant enhancement in responses. Cross-reactive MBCs were detected before vaccination and expanded after vaccination. Preexisting H3N2v-specific MBCs positively correlated with early increases in vaccine-induced Ab. In most healthy adults, one 15-µg dose of vaccine elicited levels of HAI Abs associated with protection. Studies in children and elderly individuals are indicated to define the immunization needs of these groups. NCT01746082.
    Keywords: H3n2 Variant ; Immune Responses ; Immunization ; Influenza ; Pandemic ; Antibodies, Viral -- Blood ; Influenza A Virus, H3n2 Subtype -- Immunology ; Influenza Vaccines -- Immunology ; Influenza, Human -- Prevention & Control
    ISSN: 00221899
    E-ISSN: 1537-6613
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  • 8
    Language: English
    In: Emerging Infectious Diseases, 01 July 2016, Vol.22(7), pp.1253-1256
    Description: We retrospectively analyzed data for 195 respiratory infection patients who had positive Staphyloccocus aureus cultures and who were hospitalized in 2 hospitals in Iowa and Maryland, USA, during 2003–2009. Odds for death for patients who also had influenza-positive test results were 〉4 times higher than for those who had negative influenza test results.
    Keywords: Staphylococcus Aureus ; Staphylococci ; Pneumonia ; Influenza ; Respiratory Infections ; Viruses ; Public Health
    ISSN: 1080-6040
    E-ISSN: 1080-6059
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  • 9
    Language: English
    In: Antimicrobial agents and chemotherapy, March 2013, Vol.57(3), pp.1169-72
    Description: While numerous studies have assessed the outcomes of methicillin-resistant S. aureus (MRSA) colonization over the short term, little is known about longer-term outcomes after discharge. An assessment of long-term outcomes could provide information about the utility of various MRSA prevention approaches. A matched-cohort study was performed among Veterans Affairs (VA) patients screened for MRSA colonization between the years 2007 and 2009 and followed to evaluate outcomes until 2010. Cox proportional-hazard models were used to evaluate the association between MRSA colonization and long-term outcomes, such as infection-related readmission and crude mortality. A total of 404 veterans were included, 206 of whom were MRSA carriers and 198 of whom were noncarriers. There were no culture-proven MRSA infections on readmission among the noncarriers, but 13% of MRSA carriers were readmitted with culture-proven MRSA infections on readmission (P 〈 0.01). MRSA carriers were significantly more likely to be readmitted, to be readmitted more than once due to proven or probable MRSA infections, and to be readmitted within 90 days of discharge than noncarriers (P 〈 0.05). Infection-related readmission (adjusted hazard ratio [HR] = 4.07; 95% confidence interval [CI], 2.16 to 7.67) and mortality (adjusted HR = 2.71; 95% CI, 1.87 to 3.91) were significantly higher among MRSA carriers than among noncarriers after statistically adjusting for potential confounders. Among a cohort of VA patients, MRSA carriers are at high risk of infection-related readmission, MRSA infection, and mortality compared to noncarriers. Noncarriers are at very low risk of subsequent MRSA infection. Future studies should address whether interventions such as nasal or skin decolonization could result in improved outcomes for MRSA carriers.
    Keywords: Veterans ; Methicillin-Resistant Staphylococcus Aureus -- Isolation & Purification ; Staphylococcal Infections -- Microbiology
    E-ISSN: 1098-6596
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  • 10
    In: The Journal of Infectious Diseases, 2016, Vol. 214(7), pp.1020-1029
    Description: Background.  Influenza A(H5N1) virus and other avian influenza virus strains represent major pandemic threats. Like all influenza A virus strains, A(H5N1) viruses evolve rapidly. Innovative immunization strategies are needed to induce cross-protective immunity. Methods.  Subjects primed with clade 1 H5 antigen, with or without adjuvant, and H5-naive individuals were boosted with clade 2 H5 antigen. The impact of priming on T cells capable of both proliferation and cytokine production after antigen restimulation was assessed. Results.  Subjects previously vaccinated with clade 1 H5 antigen developed significantly enhanced clade 2 H5 cross-reactive T cell responses detectable 6 months after vaccination with clade 2 H5 antigen. Priming dose (15 µg vs 45 or 90 µg) had no effect on magnitude of heterotypic H5 T cell responses. In contrast, age at priming negatively modulated both the magnitude and duration of heterotypic H5 T cell responses. Elderly subjects developed significantly less heterotypic H5 T cell boosting, predominantly for T cells capable of cytokine production. Adjuvant had a positive albeit weaker effect than age. The magnitude of CD4 + interferon–γ producing T cells correlated with H5 antibody responses. Conclusions.  H5 heterotypic priming prior to onset of an A(H5N1) pandemic may increase magnitude and duration of immunity against a newly drifted pandemic H5 virus.
    Keywords: H5n1 ; Influenza ; Vaccine ; Prime/Boost ; Human ; Clade
    ISSN: 0022-1899
    E-ISSN: 1537-6613
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