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Pediatric Wells syndrome (eosinophilic cellulitis) after vaccination: A case report and review of the literature.
Yu, AM, Ito, S, Leibson, T, Lavi, S, Fu, LW, Weinstein, M, Skotnicki, SM
Pediatric dermatology. 2018;(5):e262-e264
Abstract
A 4-year-old boy presented with erythematous vesicular plaques, ulceration, edema, and pruritus on the left foot and ankle 10 days after receiving the tetanus, diphtheria, pertussis, and polio; measles, mumps, rubella, and varicella; and hepatitis A/B vaccines. Biopsy showed eosinophilic infiltrates and flame figures, suggesting Wells syndrome. Patch testing showed a 1+ reaction to neomycin and aluminum hydroxide, with a recall reaction of Wells syndrome of the feet bilaterally. We report a rare case of pediatric Wells syndrome triggered by nonthimerosal vaccine components confirmed by patch testing.
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2.
Human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for the prevention of cervical cancer and HPV-related diseases.
Skinner, SR, Apter, D, De Carvalho, N, Harper, DM, Konno, R, Paavonen, J, Romanowski, B, Roteli-Martins, C, Burlet, N, Mihalyi, A, et al
Expert review of vaccines. 2016;(3):367-87
Abstract
Vaccines are available against human papillomavirus (HPV), the causal agent of cervical and other cancers. Efficacy data from the HPV-16/18 AS04-adjuvanted vaccine clinical trial program were reviewed. Six randomized, controlled phase II/III trials evaluating cervical endpoints enrolled women from diverse populations and geographical locations. The program analyzed extensively the cohorts most relevant from a public health perspective: the total vaccinated cohort (TVC), approximating a general population including those with existing or previous HPV infection, and TVC-naïve, approximating a population of young women before sexual debut. Results show that the vaccine reduces HPV-16/18 infection and associated cervical endpoints in women regardless of age, location, or sexual experience. It provides cross-protection against some non-vaccine oncogenic HPV types and types causing genital warts, and may be effective against vulvar, oral, and anal HPV infection. Early epidemiology data following its introduction suggest a decline in the prevalence of vaccine and some non-vaccine HPV types.
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3.
The avian influenza vaccine Emerflu. Why did it fail?
Young, BE, Sadarangani, SP, Leo, YS
Expert review of vaccines. 2015;(8):1125-34
Abstract
Emerflu is an inactivated, split-virion pandemic preparedness vaccine, containing 30 μg of hemagglutinin (HA) and 600 μg of aluminum hydroxide adjuvant. It is administered in two doses, 3 weeks apart. Only moderate immunogenicity was evident from clinical studies with the vaccine in adults, and HA antibody responses were below the criteria established by the EMA and US FDA for licensure. With the exception of Australia, the vaccine remains unlicensed. Further clinical development appears to have been suspended, and newer adjuvants such as MF59 and AS03 have since demonstrated safety and superior immunogenicity with lower HA doses. Emerflu is symbolic of the failure of aluminum salts as an adjuvant for influenza vaccines. Reasons for this failure are unclear, and may reflect problems with the adjuvant-antigen complex or interference in the immune response by heterosubtypic immunity.
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4.
Modified hydrotalcite-like compounds as active fillers of biodegradable polymers for drug release and food packaging applications.
Costantino, U, Nocchetti, M, Tammaro, L, Vittoria, V
Recent patents on nanotechnology. 2012;(3):218-30
Abstract
This review treats the recent patents and related literature, mainly from the Authors laboratories, on biomedical and food packaging applications of nano-composites constituted of biodegradable polymers filled with micro or nano crystals of organically modified Layered Double Hydroxides of Hydrotalcite type. After a brief outline of the chemical and structural aspects of Hydrotalcite-like compounds (HTlc) and of their manipulation via intercalation of functional molecular anions to obtain materials for numerous, sometime unexpected applications, the review approaches the theme in three separated parts. Part 1 deals with the synthetic method used to prepare the pristine Mg-Al and Zn-Al HTlc and with the procedures of their functionalization with anti-inflammatory (diclofenac), antibacterial (chloramphenicol hemisuccinate), antifibrinolytic (tranexamic acid) drugs and with benzoates with antimicrobial activity. Procedures used to form (nano) composites of polycaprolactone, used as an example of biodegradable polymer, and functionalized HTlc are also reported. Part 2 discusses a patent and related papers on the preparation and biomedical use of a controlled delivery system of the above mentioned pharmacologically active substances. After an introduction dealing with the recent progress in the field of local drug delivery systems, the chemical and structural aspects of the patented system constituted of a biodegradable polymer and HTlc loaded with the active substances will be presented together with an extensive discussion of the drug release in physiological medium. Part 3 deals with a recent patent and related papers on chemical, structural and release property of antimicrobial species of polymeric films containing antimicrobial loaded HTlc able to act as active packaging for food products prolonging their shelf life.
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5.
AS04-adjuvanted human papillomavirus (HPV) types 16 and 18 vaccine (Cervarix®): a review of its use in the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types.
McKeage, K, Romanowski, B
Drugs. 2011;(4):465-88
Abstract
The AS04-adjuvanted human papillomavirus (HPV) 16/18 vaccine (Cervarix®) is a noninfectious recombinant vaccine produced using purified virus-like particles (VLPs) that induce a strong immunogenic response eliciting high levels of anti-L1 VLP antibodies that persist at levels markedly greater than those observed with natural infection. The vaccine adjuvant (AS04) is composed of monophosphoryl-lipid A, which enhances cellular and humoral immune response, adsorbed to aluminium hydroxide. The vaccine is indicated for the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types in females aged ≥10 years. The AS04-adjuvanted HPV 16/18 vaccine administered in a three-dose schedule over 6 months elicits a high immunogenic response and is highly protective against cervical intraepithelial neoplasia and infection causally related to high-risk oncogenic HPV types. In well designed clinical trials in young women aged 15-25 years who were HPV 16/18 seronegative and DNA negative to 14 HPV high-risk types, high levels of immunogenicity and protection were sustained for follow-up periods of up to 8.4 years. High and persistent immunogenicity against infection with HPV 16/18 has also been demonstrated in older and younger females (aged 10-55 years) who were seronegative for vaccine HPV types. The AS04-adjuvanted HPV 16/18 vaccine elicited a greater immunogenic response than the quadrivalent HPV vaccine in women aged 18-45 years who were seronegative and DNA negative for HPV 16/18. The AS04-adjuvanted HPV 16/18 vaccine confers cross protection against certain non-vaccine, high-risk HPV types. A rapid and strong anamnestic humoral immune response was elicited following a fourth dose of the vaccine. The AS04-adjuvanted HPV 16/18 vaccine is generally well tolerated, and pharmacoeconomic analyses have demonstrated the potential for public health benefits and cost effectiveness when vaccination programmes are run in conjunction with screening programmes. Thus, the AS04-adjuvanted HPV 16/18 vaccine prevents cervical disease associated with certain oncogenic HPV types, thereby reducing the burden of premalignant cervical lesions and, very likely, cervical cancer.
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6.
Role of AS04 in human papillomavirus vaccine: mode of action and clinical profile.
Garçon, N, Wettendorff, M, Van Mechelen, M
Expert opinion on biological therapy. 2011;(5):667-77
Abstract
INTRODUCTION Understanding the mode of action of adjuvants is important for the interpretation of clinical studies. AREAS COVERED This paper discusses how the results of GSK's clinical studies with an AS04-adjuvanted human papillomavirus (HPV) vaccine are supported by the mode of action of AS04. AS04 and antigens must be injected at the same intramuscular site together or within 24 h of each other. AS04 induces local cytokine production leading to increased recruitment of dendritic cells and monocytes and raised numbers of antigen presenting cells in the draining lymph node. The localized and transient nature of the innate immune response supports the acceptable safety profile observed in clinical studies. The readers will gain a comprehensive understanding of the mode of action of AS04 and how it relates to results of clinical studies. EXPERT OPINION The AS04-adjuvanted HPV vaccine has an acceptable safety profile and induces an enhanced and sustained immune response and high protection against HPV types 16/18. Cross-protection against oncogenic HPV types 31/33/45 not contained in the vaccine is also observed. The mode of action of AS04 supports the clinical profile of the AS04-adjuvanted HPV vaccine.
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7.
AS04-adjuvanted human papillomavirus-16/18 vaccination: recent advances in cervical cancer prevention.
Schwarz, TF
Expert review of vaccines. 2008;(10):1465-73
Abstract
Persistent infection with oncogenic human papillomavirus (HPV)-16 and -18 accounts for over 70% of all cases of cervical cancer. Vaccination against these HPV types has become a reality. This article discusses the latest data available for Cervarix (GlaxoSmithKline Biologicals), an AS04-adjuvanted HPV-16/18 vaccine, and considers immunological factors important in vaccine effectiveness. High and sustained HPV-16 and -18 antibody levels have now been observed together with 100% vaccine efficacy in preventing HPV-16/18-related persistent infections and cervical intraepithelial neoplasia grade 2 and above, up to 6.4 years after first vaccination. Significant crossprotection against incident and persistent infection has been observed, notably against HPV-45, the third most prevalent HPV type in cervical cancer. An integrated safety summary of Phase II/III trials has shown that GlaxoSmithKline's HPV-16/18 AS04-adjuvanted vaccine is generally safe. Further studies will reveal the full duration and extent of the immune response and protection induced by Cervarix in broad populations and age ranges of women.
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8.
[Phosphate binder up to date].
Shigematsu, T, Sakaguchi, T, Orita, H
Clinical calcium. 2007;(5):772-8
Abstract
It has become clear that hyperphosphatemia is the major risk factor on the patients' survival undergoing regular renal replacement therapy. One of the mechanism of this impact on survival is ectopic calcification like vascular calcification. The standard therapy for hyperphosphatemia is phosphate removal by renal replacement therapy. However, since the amount of phosphate removal with today's hemodialysis procedure is not enough, the phosphate binder as depressant of phosphate absorption is still essential. Aluminum compound had been prohibited from 1992 due to serious adverse effect like aluminum encephalopathy and osteomalacia.Calcium carbonate and sevelamer hydrochloride are common phosphate binder. The combination therapy of both phosphate binders is recommended to avoid involvement in adverse effects of the both drugs. Lanthanum carbonate is developing compound as a new and powerful phosphate binder. It is expected as a new non-calcium and non-aluminum phosphate binder with powerful phosphate binding effect. However, the adverse effect of the Lanthanum carbonate is still obscure. Further investigation is acquired.