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      Immunogenicity Profile of a 3.75-μg Hemagglutinin Pandemic rH5N1 Split Virion AS03 A-Adjuvanted Vaccine in Elderly Persons: A Randomized Trial

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          Abstract

          Background.  Elderly persons often experience a reduced immune response to influenza vaccination. We evaluated the usual dose of AS03 A-adjuvanted H5N1 pandemic vaccine (3.75 μg hemagglutinin of A/Vietnam/1194/2004-like strain) compared with a double dose in an elderly population.

          Methods.  This phase 2, open-label study (NCT00397215; http://www.clinicaltrials.gov) randomized participants (age, ≥61 years) to receive, on days 0 and 21: (1) a single dose of AS03 A-adjuvanted vaccine ( n = 152), (2) a single dose of nonadjuvanted vaccine ( n = 54), (3) a double dose of AS03 A-adjuvanted vaccine ( n = 145), or (4) a double dose of nonadjuvanted vaccine ( n = 44). The primary end point was hemagglutination inhibition (HI) and neutralizing antibody response against vaccine antigen (according-to-protocol cohort).

          Results.  Day 42 geometric mean titers for HI antibodies were 126.8 and 237.3 for single and double doses of the AS03 A-adjuvanted vaccine, respectively. Corresponding values for neutralizing antibodies were 447.3 and 595.8. Although the immune response was higher with the double dose, European Committee for Human Medicinal Products criteria for seroconversion and seroprotection rates were achieved in both AS03 A-adjuvanted groups. Antigen-specific CD4 T cell responses were elicited. Immune response persistence at 6 months was high. Immune response in the non-adjuvanted groups was considerably less.

          Conclusions.  The AS03 A-adjuvanted H5N1 vaccine can be administered elderly persons at the same dose and schedule as in younger adults.

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          Mitigation strategies for pandemic influenza in the United States.

          Timothy Germann, Kai Kadau, Ira Longini … (2006)
          Recent human deaths due to infection by highly pathogenic (H5N1) avian influenza A virus have raised the specter of a devastating pandemic like that of 1917-1918, should this avian virus evolve to become readily transmissible among humans. We introduce and use a large-scale stochastic simulation model to investigate the spread of a pandemic strain of influenza virus through the U.S. population of 281 million individuals for R(0) (the basic reproductive number) from 1.6 to 2.4. We model the impact that a variety of levels and combinations of influenza antiviral agents, vaccines, and modified social mobility (including school closure and travel restrictions) have on the timing and magnitude of this spread. Our simulations demonstrate that, in a highly mobile population, restricting travel after an outbreak is detected is likely to delay slightly the time course of the outbreak without impacting the eventual number ill. For R(0) < 1.9, our model suggests that the rapid production and distribution of vaccines, even if poorly matched to circulating strains, could significantly slow disease spread and limit the number ill to <10% of the population, particularly if children are preferentially vaccinated. Alternatively, the aggressive deployment of several million courses of influenza antiviral agents in a targeted prophylaxis strategy may contain a nascent outbreak with low R(0), provided adequate contact tracing and distribution capacities exist. For higher R(0), we predict that multiple strategies in combination (involving both social and medical interventions) will be required to achieve similar limits on illness rates.
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            Duration of antiviral immunity after smallpox vaccination.

            Erika Hammarlund, Matthew W Lewis, Scott G Hansen … (2003)
            Although naturally occurring smallpox was eliminated through the efforts of the World Health Organization Global Eradication Program, it remains possible that smallpox could be intentionally released. Here we examine the magnitude and duration of antiviral immunity induced by one or more smallpox vaccinations. We found that more than 90% of volunteers vaccinated 25-75 years ago still maintain substantial humoral or cellular immunity (or both) against vaccinia, the virus used to vaccinate against smallpox. Antiviral antibody responses remained stable between 1-75 years after vaccination, whereas antiviral T-cell responses declined slowly, with a half-life of 8-15 years. If these levels of immunity are considered to be at least partially protective, then the morbidity and mortality associated with an intentional smallpox outbreak would be substantially reduced because of pre-existing immunity in a large number of previously vaccinated individuals.
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              Detection of antibody to avian influenza A (H5N1) virus in human serum by using a combination of serologic assays.

              T. Rowe, R A Abernathy, J Hu-Primmer … (1999)
              From May to December 1997, 18 cases of mild to severe respiratory illness caused by avian influenza A (H5N1) viruses were identified in Hong Kong. The emergence of an avian virus in the human population prompted an epidemiological investigation to determine the extent of human-to-human transmission of the virus and risk factors associated with infection. The hemagglutination inhibition (HI) assay, the standard method for serologic detection of influenza virus infection in humans, has been shown to be less sensitive for the detection of antibodies induced by avian influenza viruses. Therefore, we developed a more sensitive microneutralization assay to detect antibodies to avian influenza in humans. Direct comparison of an HI assay and the microneutralization assay demonstrated that the latter was substantially more sensitive in detecting human antibodies to H5N1 virus in infected individuals. An H5-specific indirect enzyme-linked immunosorbent assay (ELISA) was also established to test children's sera. The sensitivity and specificity of the microneutralization assay were compared with those of an H5-specific indirect ELISA. When combined with a confirmatory H5-specific Western blot test, the specificities of both assays were improved. Maximum sensitivity (80%) and specificity (96%) for the detection of anti-H5 antibody in adults aged 18 to 59 years were achieved by using the microneutralization assay combined with Western blotting. Maximum sensitivity (100%) and specificity (100%) in detecting anti-H5 antibody in sera obtained from children less than 15 years of age were achieved by using ELISA combined with Western blotting. This new test algorithm is being used for the seroepidemiologic investigations of the avian H5N1 influenza outbreak.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Infect Dis
                Journal ID (hwp): jinfdis
                Journal ID (publisher-id): jinfdis
                Title: The Journal of Infectious Diseases
                Publisher: Oxford University Press
                ISSN (Print): 0022-1899
                ISSN (Electronic): 1537-6613
                Publication date (Print): 15 April 2011
                Volume: 203
                Issue: 8
                Pages: 1054-1062
                Affiliations
                [1 ]ResearchLink, Department Clinical Trial Network, Linkebeek, Flemish Brabant
                [2 ]GlaxoSmithKline Biologicals, Wavre, Walloon Brabant, Belgium
                [3 ]Department of Health Sciences and San Martino Teaching Hospital, University of Genoa, Genoa, Italy
                Author notes
                Correspondence: Stéphane Heijmans, MD, Rue de la Station 78, 1630 Linkebeek, Belgium ( stephane.heijmans@ 123456researchlink.be ).

                Potential conflicts of interest: G.I. has been an investigator of studies sponsored by GlaxoSmithKline (GSK) and has participated in symposia funded by GSK Biologicals, Italy; his institution has received grant support from GSK Biologicals for conducting this study. S. H. has received compensation from GSK Biologicals for travel and accommodation expenses to present data from this study at a congress in 2008. M.D.M. has received investigator fees from GSK Biologicals for conducting this study. P.-Y.D. has received grant support and D. G.'s and E.D.'s institutions have received honoraria via ResearchLink for conducting this and other vaccine studies. M.D., F.R., and P.G. are employees of GSK Biologicals. F.R. and P.G. report ownership of stock options.

                Presented in part: The 2nd Vaccine Congress, Boston, Massachusetts, 7-9 December 2008. Abstract AS03.

                [a]

                Deceased.

                Article
                DOI: 10.1093/infdis/jiq174
                PMC ID: 3068020
                PubMed ID: 21450995
                SO-VID: 737a9815-fbbc-42c6-a193-9a442c0574db
                Copyright © © The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/2.5), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 15 June 2010
                Date accepted : 13 October 2010
                Categories
                Subject: Major Articles and Brief Reports
                Subject: Viruses

                ScienceOpen disciplines: Infectious disease & Microbiology
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology

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