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      Vero cell technology for rapid development of inactivated whole virus vaccines for emerging viral diseases

      1 , 1 , 1 , 1 , 1
      Expert Review of Vaccines
      Informa UK Limited

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          DNA vaccines: an historical perspective and view to the future.

          Aiqin Liu (2010)
          This review provides a detailed look at the attributes and immunologic mechanisms of plasmid DNA vaccines and their utility as laboratory tools as well as potential human vaccines. The immunogenicity and efficacy of DNA vaccines in a variety of preclinical models is used to illustrate how they differ from traditional vaccines in novel ways due to the in situ antigen production and the ease with which they are constructed. The ability to make new DNA vaccines without needing to handle a virulent pathogen or to adapt the pathogen for manufacturing purposes demonstrates the potential value of this vaccine technology for use against emerging and epidemic pathogens. Similarly, personalized anti-tumor DNA vaccines can also readily be made from a biopsy. Because DNA vaccines bias the T-helper (Th) cell response to a Th1 phenotype, DNA vaccines are also under development for vaccines against allergy and autoimmune diseases. The licensure of four animal health products, including two prophylactic vaccines against infectious diseases, one immunotherapy for cancer, and one gene therapy delivery of a hormone for a food animal, provides evidence of the efficacy of DNA vaccines in multiple species including horses and pigs. The size of these target animals provides evidence that the somewhat disappointing immunogenicity of DNA vaccines in a number of human clinical trials is not due simply to the larger mass of humans compared with most laboratory animals. The insights gained from the mechanisms of protection in the animal vaccines, the advances in the delivery and expression technologies for increasing the potency of DNA vaccines, and encouragingly potent human immune responses in certain clinical trials, provide insights for future efforts to develop DNA vaccines into a broadly useful vaccine and immunotherapy platform with applications for human and animal health. © 2010 John Wiley & Sons A/S.
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            Hemagglutination inhibition antibody titers as a correlate of protection for inactivated influenza vaccines in children.

            The hemagglutination inhibition (HI) titer of 1:40, which has been recognized as an immunologic correlate corresponding to a 50% reduction in the risk of contracting influenza, is based on studies in adults. Neither seasonal nor challenge-based correlates have been evaluated in children. A total of 4707 influenza vaccine-naive healthy children 6 to 72 months old were randomized in a ratio of 2:2:1 to receive 2 doses of MF-59-adjuvanted influenza vaccine (Novartis Vaccines), trivalent inactivated influenza vaccine subunit (trivalent inactivated influenza vaccine control, GSK), or a saline placebo during the 2007 to 2008 and 2008 to 2009 influenza seasons. The second dose was given 30 days after dose 1. Clinical influenza-like illnesses cases identified by active surveillance were confirmed by reverse transcription polymerase chain reaction testing for influenza. Vaccine immunogenicity 50 days after dose 1 was evaluated in a subset of 777 children. Immunogenicity and efficacy results for H3N2 were evaluated against the Prentice criteria, which confirmed that the immunogenicity results warranted estimation of an immunologic correlate. We then used the Dunning model fitting the H3N2 antibody titers at day 50 and the influenza cases observed in the immunogenicity subset to estimate a correlate of protection. This analysis revealed that a cutoff HI titer of 1:110 was associated with the conventional 50% clinical protection rate against infection during the entire season, and titers of 1:215, 1:330, and 1:629 predicated protection rates of 70%, 80%, and 90%, respectively. The conventional adult HI titer of 1:40 was only associated with 22% protection. The use of the 1:40 HI adult correlate of protection is not appropriate when evaluating influenza vaccines in children. Although a cutoff of 1:110 may be used to predict the conventional 50% clinical protection rate, a titer of 1:330 would predict an 80% protective level, which would seem to be more desirable from a public health perspective.
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              Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection.

              Antibody to influenza virus hemagglutinin has been traditionally associated with protection. Questions have been raised about its use as a surrogate for vaccine efficacy, particularly with regard to an absolute titer indicating seroprotection. We examined hemagglutination-inhibition (HAI) antibody titers in subjects from a placebo-controlled trial of inactivated and live attenuated vaccines and compared titers in subjects with symptomatic influenza (cases) to those without influenza infection (noncases). Prevaccination and postvaccination geometric mean titers were both significantly lower for cases compared with noncases in all intervention groups. Frequency of postvaccination seroconversion did not significantly differ for cases and noncases in either vaccine group. Among live attenuated vaccine and placebo recipients, cases were less likely than noncases to have postvaccination HAI titers ≥32 or 64. Nearly all recipients of inactivated vaccine had postvaccination titers of at least 64, and the small number of vaccine failures were scattered across titers ranging from 64 to 2048. While HAI antibody is the major correlate of protection, postvaccination titers alone should not be used as a surrogate for vaccine efficacy. Vaccine failures from clinical trials need to be examined to determine why seemingly protective HAI titers may not protect. Clinical Trials Registration. NCT00538512.
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                Author and article information

                Journal
                Expert Review of Vaccines
                Expert Review of Vaccines
                Informa UK Limited
                1476-0584
                1744-8395
                July 28 2017
                September 02 2017
                July 27 2017
                September 02 2017
                : 16
                : 9
                : 883-894
                Affiliations
                [1 ] Nanotherapeutics Inc., Alachua, FL, USA
                Article
                10.1080/14760584.2017.1357471
                28724343
                07e99a6a-0739-47e3-b796-4bea8f00923f
                © 2017
                History

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