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Leroux-Roels I.,Ghent University | Leroux-Roels G.,Ghent University | Clement F.,Ghent University | Vandepapeliere P.,Neovacs Inc. | And 3 more authors.
Journal of Infectious Diseases | Year: 2012

Background. An adjuvanted recombinant varicella zoster virus (VZV) subunit vaccine is being developed for the prevention of herpes zoster and its complications.Methods.In a phase I/II, open-label, randomized, parallel-group study, older adults (50-70 years) received 2 doses 2 months apart of an adjuvanted recombinant glycoprotein E vaccine (HZ/su; n = 45), a live attenuated Oka strain VZV vaccine (OKA; n = 45), or HZ/su and OKA administered concomitantly (n = 45). To evaluate safety prior to administration in older adults, young adults (18-30 years) were vaccinated with 2 doses 2 months apart of HZ/su (n = 10) or OKA (n = 10). Safety and immunogenicity were assessed up to 42 months for older adults immunized with HZ/su and up to 12 months for all others.Results.Few grade 3 events and no severe adverse events were reported. Fatigue, myalgia, headache, and injection site pain were the most common solicited reactions for HZ/su and occurred more frequently than with OKA. CD4+ T-cell and humoral immune responses were much higher with HZ/su than with OKA and remained elevated until 42 months. Addition of OKA to HZ/su did not increase immunogenicity.Conclusions.In this study, HZ/su adjuvanted subunit vaccine was well tolerated and more immunogenic than a live attenuated VZV vaccine. © 2012 The Author.

Le Buanec H.,French Institute of Health and Medical Research | Le Buanec H.,University Paris Diderot | Bensussan A.,French Institute of Health and Medical Research | Bensussan A.,University Paris Diderot | And 4 more authors.
Advances in Immunology | Year: 2012

Anticytokine (AC) immune therapies derived from vaccine procedures aim at enhancing natural immune defense mechanisms ineffective to contain abnormally produced cytokines and counteract their pathogenic effects. Given their short half-life, cytokines, the production of which by effector immune cells (T and B lymphocytes, antigen-presenting cells (APCs), natural killer (NK) and endothelial cells) is inducible and controlled by negative feedback regulation, (1) exert locally their signaling to paracrine/autocrine target responder cells carrying high-affinity membrane receptors and (2) are commonly present at minimal concentration in the body fluid (lymph, serum). Aberrant signaling triggered by cytokines, uncontrolly released by effector immune cells or produced by cancer and other pathologic cells, contribute to the pathogenesis of chronic diseases including cancer, viral infections, allergy, and autoimmunity. To block these ectopic cytokine signaling and prevent their pathogenic effects, AC Abs supplied either by injections (passive AC immune therapy) or elicited by immunization with cytokine-derived immunogenes called Kinoids (active AC immune therapy) proved to be experimentally effective and safe. In this review, we detailed the rationale and the requirements for the use of AC immunotherapies in humans, the proof of efficacy of these medications in animal disease models, and their current clinical development and outcome, including adverse side effects they may generate. We particularly show that, to date, the benefit:risk ratio of AC immune therapies is highly positive. © 2012 Elsevier Inc..

Mahoney R.T.,Korean International Vaccine Institute | Francis D.P.,Global Solutions for Infectious Diseases | Frazatti-Gallina N.M.,Instituto Butantan | Precioso A.R.,Instituto Butantan | And 4 more authors.
Vaccine | Year: 2012

Background: A vaccine to prevent dengue disease is urgently needed. Fortunately, a few tetravalent candidate vaccines are in the later stages of development and show promise. But, if the cost of these candidates is too high, their beneficial potential will not be realized. The price of a vaccine is one of the most important factors affecting its ultimate application in developing countries. In recent years, new vaccines such as those for human papilloma virus and pneumococcal disease (conjugate vaccine) have been introduced with prices in developed countries exceeding $50 per dose. These prices are above the level affordable by developing countries. In contrast, other vaccines such as those against Japanese encephalitis (SA14-14-2 strain vaccine) and meningitis type A have prices in developing countries below one dollar per dose, and it is expected that their introduction and use will proceed more rapidly. Because dengue disease is caused by four related viruses, vaccines must be able to protect against all four. Although there are several live attenuated dengue vaccine candidates under clinical evaluation, there remains uncertainty about the cost of production of these tetravalent vaccines, and this uncertainty is an impediment to rapid progress in planning for the introduction and distribution of dengue vaccines once they are licensed. Method: We have undertaken a detailed economic analysis, using standard industrial methodologies and applying generally accepted accounting practices, of the cost of production of a live attenuated vaccine, originally developed at the US National Institutes of Health (National Institute of Allergy and Infectious Diseases), to be produced at the Instituto Butantan in Sao Paulo, Brazil. We determined direct costs of materials, direct costs of personnel and labor, indirect costs, and depreciation. These were analyzed assuming a steady-state production of 60 million doses per year. Results: Although this study does not seek to compute the price of the final licensed vaccine, the cost of production estimate produced here leads to the conclusion that the vaccine can be made available at a price that most ministries of health in developing countries could afford. This conclusion provides strong encouragement for supporting the development of the vaccine so that, if it proves to be safe and effective, licensure can be achieved soon and the burden of dengue disease can be reduced. © 2012 Elsevier Ltd.

Neovacs Inc. | Date: 2012-04-04

An immunogenic product including IFN coupled to a carrier protein molecule is capable to induce in vivo anti-IFN antibodies and is useful in treating IFN related conditions.

Neovacs Inc. | Date: 2014-01-22

Pharmaceutical preparations, namely, drugs and vaccines used for treating viral, auto-immune, and chronic inflammatory diseases.

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