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Elmar A Joura - One of the best experts on this subject based on the ideXlab platform.

Paul L Mccormack - One of the best experts on this subject based on the ideXlab platform.

  • quadrivalent human papillomavirus types 6 11 16 18 Recombinant Vaccine gardasil a review of its use in the prevention of premalignant anogenital lesions cervical and anal cancers and genital warts
    Drugs, 2014
    Co-Authors: Paul L Mccormack
    Abstract:

    Quadrivalent human papillomavirus (HPV) [types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®; Silgard®) is composed of virus-like particles formed by self-assembly of Recombinant L1 capsid protein from each of HPV types 6, 11, 16 and 18. It is indicated for use from the age of 9 years as a two- or three-dose vaccination course over 6 months for the prevention of premalignant anogenital lesions, cervical and anal cancers, and genital warts caused by the Vaccine HPV types. In placebo-controlled trials, quadrivalent HPV Vaccine provided high-level protection against infection or disease caused by the Vaccine HPV types over 2–4 years in females aged 15–45 years who were negative for the Vaccine HPV types, and provided a degree of cross-protection against certain non-Vaccine HPV types. The Vaccine also provided high-level protection against persistent infection, anogenital precancerous lesions and genital warts caused by the Vaccine HPV types over 3 years in susceptible males aged 16–26 years. Protection has been demonstrated for up to 8 years. In subjects who were negative for the Vaccine HPV types, high seroconversion rates and high levels of anti-HPV antibodies were observed in females of all age ranges from 9 to 45 years and in males aged 9–26 years. The Vaccine was generally well tolerated and was usually predicted to be cost effective in girls and young women. Therefore, quadrivalent HPV Vaccine offers an effective means to substantially reduce the burden of HPV-related anogenital disease in females and males, particularly cervical cancer and genital warts.

  • spotlight on quadrivalent human papillomavirus types 6 11 16 18 Recombinant Vaccine gardasil in the prevention of premalignant genital lesions genital cancer and genital warts in women
    BioDrugs, 2011
    Co-Authors: Paul L Mccormack, Elmar A Joura
    Abstract:

    Quadrivalent human papilloma virus (HPV) [types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®; Silgard®) is composed of virus-like particles (VLPs) formed by self-assembly of Recombinant L1 capsid protein from each of HPV types 6, 11, 16, and 18. The VLPs are noninfectious, containing no DNA, and are highly immunogenic, inducing high levels of neutralizing antibodies against the particular HPV types when administered to animals or humans. Quadrivalent HPV Vaccine is indicated for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar, and vaginal), cervical cancer, and external genital warts (condyloma acuminata) causally related to certain oncogenic or specific HPV types.

  • quadrivalent human papillomavirus types 6 11 16 18 Recombinant Vaccine gardasil a review of its use in the prevention of premalignant genital lesions genital cancer and genital warts in women
    Drugs, 2010
    Co-Authors: Paul L Mccormack, Elmar A Joura
    Abstract:

    Quadrivalent human papilloma virus (HPV) [types 6, 11, 16, 18] Recombinant Vaccine (Gardasil®; Silgard®) is composed of virus-like particles (VLPs) formed by self-assembly of Recombinant L1 capsid protein from each of HPV types 6,11, 16 and 18. The VLPs are noninfectious, containing no DNA, and are highly immunogenic, inducing high levels of neutralizing antibodies against the particular HPV types when administered to animals or humans. Quadrivalent HPV Vaccine is indicated for use from the age of 9 years for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to certain oncogenic or specific HPV types.

J J Esposito - One of the best experts on this subject based on the ideXlab platform.

  • raccoon poxvirus rabies virus glycoprotein Recombinant Vaccine
    1993
    Co-Authors: J C Demartini, Heidi M Bickle, Scott J Brodie, J J Esposito
    Abstract:

    Raccoon poxvirus rabies virus glycoprotein Recombinant Vaccine in sheep Brief Report J. C. DeMartini 1, Heidi M. Bickle 1, S. J. Brodie 1'*, B. X. He 2, and J. J. Esposito 2 1 Department of Pathology, Colorado State University, Fort Collins, Colorado a Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, U.S.A. Accepted May 22, 1993 Summary. Twenty sheep were divided into groups and inoculated by various routes with Recombinant raccoon poxvirus expressing the CVS rabies virus glycoprotein (rRCNV-G) or with raccoon poxvirus (RCNV). The apparent innocuous pathologic responses to each virus coupled with development of high levels of rabies virus neutralizing antibodies in animals vaccinated with rRCNV- G intradermally or intramuscularly suggested that the Recombinant is effective and that RCNV would be a suitable substrate for further development of sheep Vaccines. Poor antibody response to rRCNV-G given orally implied that it would be relatively harmless if inadvertently ingested by sheep. Virus trans- mission between vaccinated and sentinel sheep was not observed or detected serologically. Recombinant Vaccines hold considerable promise for disease control [3, 4, 12], and it is probable that Recombinant Vaccines with the capacity to immunize against several diseases will soon be widely available [16]. Most of the recom- binant virus Vaccines developed to date, including a very effective Vaccine for rinderpest in cattle [29], use vaccinia virus as a vector [12, 17, 18, 21-24, 27]. Fox rabies has been controlled in southern Belgium with the aid of a field-bait delivery system employing an apparently safe Recombinant vaccinia-rabies vac- * Present address: New England Regional Primate Research Center, Harvard Medical School, Southborough, MA, U.S.A.

  • raccoon poxvirus rabies virus glycoprotein Recombinant Vaccine in sheep
    Archives of Virology, 1993
    Co-Authors: J C Demartini, Heidi M Bickle, Scott J Brodie, J J Esposito
    Abstract:

    Twenty sheep were divided into groups and inoculated by various routes with Recombinant raccoon poxvirus expressing the CVS rabies virus glycoprotein (rRCNV-G) or with raccoon poxvirus (RCNV). The apparent innocuous pathologic responses to each virus coupled with development of high levels of rabies virus neutralizing antibodies in animals vaccinated with rRCNV-G intradermally or intramuscularly suggested that the Recombinant is effective and that RCNV would be a suitable substrate for further development of sheep Vaccines. Poor antibody response to rRCNV-G given orally implied that it would be relatively harmless if inadvertently ingested by sheep. Virus transmission between vaccinated and sentinel sheep was not observed or detected serologically.

Willis C Maddrey - One of the best experts on this subject based on the ideXlab platform.

  • adult hepatitis b vaccination using a novel triple antigen Recombinant Vaccine
    Hepatology, 2001
    Co-Authors: Michael D Young, David L Schneider, Arie J Zuckerman, Brian Dickson, Willis C Maddrey
    Abstract:

    Present hepatitis B Vaccines use multidose prolonged regimens, which even healthcare workers at risk do not always complete. Moreover, when vaccination is completed there remain some who fail to achieve adequate protection. The protection of adults at risk could be improved if there were a more potent Vaccine and/or a shorter vaccination regimen available. Vaccine-naive adults were randomized to vaccination with either Engerix-B (SmithKline Biologicals, Rixensart, Belgium) or a novel triple antigen (S, pre-S1, and pre-S2) Recombinant Vaccine (Hepacare; Medeva Pharma Plc, Speke, UK). The primary efficacy parameter was the degree of seroprotection 6 or 7 months (26 ± 2 weeks) after beginning vaccination. A total of 304 adults entered the study. Of these, 16 failed to complete the study (9 on Hepacare and 7 on Engerix-B). With the Engerix-B standard (0, 1, 6) regimen, 88% of subjects were protected by month 7, whereas with the triple antigen Vaccine a 2-dose regimen (0, 1) provided equivalent protection (91%) within 6 months and a 3-dose (0, 1, 6) regimen was significantly superior (98% seroprotected by 7 months after starting vaccination P < .001). With adults at risk for a suboptimal response (i.e., older adults, the obese, men, and smokers) the triple antigen Vaccine produced a greater degree of protection. The Vaccines had similar safety profiles. Both Vaccines were well tolerated. In healthy normal adults, a triple antigen hepatitis B Vaccine containing S and pre-S antigens produced an enhanced immunologic response and was as effective as a 2- and 3-dose regimen. (HEPATOLOGY 2001;34:372-376.)

  • comparison of a triple antigen and a single antigen Recombinant Vaccine for adult hepatitis b vaccination
    Journal of Medical Virology, 2001
    Co-Authors: Michael D Young, Arie J Zuckerman, Brian Dickson, Manford W Gooch, Willis C Maddrey
    Abstract:

    Hepatitis B and its sequelae are a major public health problem. Vaccines have been available for almost 20 years; however the disease still remains a global problem. Many factors contribute to the failure to control hepatitis B, including the limited nature of the vaccination programs implemented initially. Only relatively recently has mass childhood vaccination begun to be implemented and vaccination of high-risk groups, other than healthcare workers, is still not general policy. Additional factors contributing to continued persistence of hepatitis B in the developed world are that the present Vaccines are not fully used by those recommended to be vaccinated and even when vaccination is carried out appropriately, there remain some who fail to achieve adequate protection. Clearly, the protection of at-risk groups who have inadequate response to current Vaccines, and those who are unwilling or unable to comply with protracted multi-dose Vaccine regimens, could be improved if there were a more potent Vaccine and/or a shorter vaccination regimen available. Adults who had never been vaccinated against hepatitis B were randomised to receive a vaccination course of either a present single antigen (S) Vaccine (Recombivax-HB) or a novel triple antigen (S, pre-S1, and pre-S2) Recombinant Vaccine (Hepacare Medeva Pharma plc). Doses were given at baseline and 1 month and 6 months later. Hepatitis B surface antibody (anti-HBs) levels were measured at 2, 4, 6, and 7 months after beginning vaccination. The primary efficacy parameter was the degree of protection, measured as the percentage of subjects with anti-HBs titres > or = 10 IU/L, 6 or 7 months (26 +/- 2 weeks) after beginning vaccination. A total of 303 adult subjects entered the study and were vaccinated. Of these, 11 failed to complete the study (4 on Hepacare and 7 on Recombivax-HB); however all but 2 (1 to receive the triple antigen Vaccine and 1 to receive Recombivax-HB) were included in the intent-to-treat population for efficacy evaluation. Treatment randomisation was stratified at entry based on age (above and below 40 years old) and gender. The standard three-dose/6-month vaccination regimen of the single antigen Vaccine protected 83% of subjects by 7 months after starting vaccination whereas the triple antigen Vaccine as a two-dose/1-month regimen protected 88% within 6 months and as a three-dose/6-month regimen protected 97% by 7 months after starting vaccination. Thus the protection rate provided by the shortened (0, 1) regimen of the novel Vaccine was "essentially equivalent" (i.e., not statistically inferior) to that provided by the full (0, 1, and 6) regimen of today's Vaccine (88% vs. 81%, P /=40), the obese, males, and smokers], the triple antigen Vaccine produced a significantly greater percentage of protected subjects (P or = 10%) reported adverse events with the use of either Vaccine were pain at the site of injection (38% vs. 41% vs. 20% for the two-dose Hepacare regimen, the three-dose Hepacare regimen, and the three-dose Recombivax-HB regimen, respectively), infections at the site of injection (1% vs. 14% vs. 9%), headache (9% vs. 13% vs. 11%), and nausea (7% vs. 11% vs. 3%). It is concluded that in healthy normal adults, a triple antigen hepatitis B Vaccine that contained S and pre-S antigens produced an enhanced immunological response. This was exemplified by the novel Vaccine's ability to overcome factors such as advancing age (> or = 40 years), obesity, and smoking, each of which is known to reduce the potential for protection with present Recombinant S only Vaccines. A two-dose/1-month (0 and 1) regimen of this triple antigen Vaccine was as effective as the standard three-dose/6 month (0, 1, and 6) regimen of present single antigen Vaccines. (c) 2001 Wiley-Liss, Inc.

  • a multi center controlled study of rapid hepatitis b vaccination using a novel triple antigen Recombinant Vaccine
    Vaccine, 2001
    Co-Authors: Michael D Young, Brian Dickson, M H Rosenthal, Willis C Maddrey
    Abstract:

    Hepatitis B Vaccines have been available for 20 years, however, the disease still remains a global problem. Clearly, the protection of at-risk groups could be improved if a more potent Vaccine with a shorter vaccination regimen were available. Hepacare is new Recombinant Vaccine, which contains three of the surface antigens of the HB virus and has higher immunogenicity than present single antigen (HBsAg only) Vaccines. This study evaluates the potential for developing seroprotection rapidly and the viability of a 1 month/two dose regimen. A total of 400 adult subjects were vaccinated using either the present accelerated 2 month/three dose regimen of Engerix-B or a 1 month/two dose regimen of a novel triple antigen Vaccine (Hepacare). Both Vaccines were well tolerated. Four weeks after a single dose, the seroprotective rates for Engerix-B and the triple antigen Vaccine were 5 and 17%, respectively. By month 2, 4 weeks after two doses of Vaccine, it was 38 and 61%. Finally by month 3, 4 weeks after a third dose of Engerix-B or placebo, respectively, the seroprotection rates were 71 and 82%. The geometric mean titres (GMTs), of these responders was then 119 and 120 IU/l, respectively. Both Vaccines were well tolerated. At all points up to and including 3 months after beginning vaccination, the novel 1 month/two dose regimen of Hepacare was significantly more effective in producing seroporotective titres than the 2 month/three dose regimen of Engerix-B (P = 0.001).

J C Demartini - One of the best experts on this subject based on the ideXlab platform.

  • raccoon poxvirus rabies virus glycoprotein Recombinant Vaccine
    1993
    Co-Authors: J C Demartini, Heidi M Bickle, Scott J Brodie, J J Esposito
    Abstract:

    Raccoon poxvirus rabies virus glycoprotein Recombinant Vaccine in sheep Brief Report J. C. DeMartini 1, Heidi M. Bickle 1, S. J. Brodie 1'*, B. X. He 2, and J. J. Esposito 2 1 Department of Pathology, Colorado State University, Fort Collins, Colorado a Division of Viral and Rickettsial Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, U.S.A. Accepted May 22, 1993 Summary. Twenty sheep were divided into groups and inoculated by various routes with Recombinant raccoon poxvirus expressing the CVS rabies virus glycoprotein (rRCNV-G) or with raccoon poxvirus (RCNV). The apparent innocuous pathologic responses to each virus coupled with development of high levels of rabies virus neutralizing antibodies in animals vaccinated with rRCNV- G intradermally or intramuscularly suggested that the Recombinant is effective and that RCNV would be a suitable substrate for further development of sheep Vaccines. Poor antibody response to rRCNV-G given orally implied that it would be relatively harmless if inadvertently ingested by sheep. Virus trans- mission between vaccinated and sentinel sheep was not observed or detected serologically. Recombinant Vaccines hold considerable promise for disease control [3, 4, 12], and it is probable that Recombinant Vaccines with the capacity to immunize against several diseases will soon be widely available [16]. Most of the recom- binant virus Vaccines developed to date, including a very effective Vaccine for rinderpest in cattle [29], use vaccinia virus as a vector [12, 17, 18, 21-24, 27]. Fox rabies has been controlled in southern Belgium with the aid of a field-bait delivery system employing an apparently safe Recombinant vaccinia-rabies vac- * Present address: New England Regional Primate Research Center, Harvard Medical School, Southborough, MA, U.S.A.

  • raccoon poxvirus rabies virus glycoprotein Recombinant Vaccine in sheep
    Archives of Virology, 1993
    Co-Authors: J C Demartini, Heidi M Bickle, Scott J Brodie, J J Esposito
    Abstract:

    Twenty sheep were divided into groups and inoculated by various routes with Recombinant raccoon poxvirus expressing the CVS rabies virus glycoprotein (rRCNV-G) or with raccoon poxvirus (RCNV). The apparent innocuous pathologic responses to each virus coupled with development of high levels of rabies virus neutralizing antibodies in animals vaccinated with rRCNV-G intradermally or intramuscularly suggested that the Recombinant is effective and that RCNV would be a suitable substrate for further development of sheep Vaccines. Poor antibody response to rRCNV-G given orally implied that it would be relatively harmless if inadvertently ingested by sheep. Virus transmission between vaccinated and sentinel sheep was not observed or detected serologically.