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David L Swerdlow - One of the best experts on this subject based on the ideXlab platform.
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surveillance guidelines for smallpox Vaccine Vaccinia adverse reactions
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports Centers for Disease Control, 2006Co-Authors: Christine G Casey, Claudia Vellozzi, Gina T Mootrey, Louisa E Chapman, Mary M Mccauley, Martha H Roper, David L SwerdlowAbstract:CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (Vaccinia) Vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal Vaccinia; generalized Vaccinia; accidental autoinoculation, nonocular; ocular Vaccinia; progressive Vaccinia; erythema multiforme major; postVaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular Vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox Vaccine surveillance case definitions presented in the report can be used in future vaccination programs to ensure uniform reporting guidelines and case classification.
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adverse events associated with smallpox vaccination in the united states january october 2003
JAMA, 2005Co-Authors: John K Iskander, Louisa E Chapman, Martha H Roper, David L Swerdlow, Eric E Mast, Xiaojun Wen, Thomas J Torok, Juliette Morgan, James D HeffelfingerAbstract:ContextOn January 24, 2003, the US Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (Vaccinia) Vaccine was administered to federal, state, and local volunteers who might be first responders during a bioterrorism event.ObjectiveTo describe results from the comprehensive DHHS smallpox Vaccine safety monitoring and response system.Design, Setting, and ParticipantsDescriptive study of adverse event reports from the DHHS smallpox Vaccine safety monitoring and response system received between January 24 and October 31, 2003, through the Vaccine Adverse Event Reporting System (VAERS) and the Centers for Disease Control and Prevention. A total of 37 901 volunteers in 55 jurisdictions received at least 1 dose of smallpox Vaccine.Main Outcome MeasuresNumber of vaccinations administered and description of adverse events and reporting rates.ResultsA total of 38 885 smallpox vaccinations were administered, with a take rate of 92%. VAERS received 822 reports of adverse events following smallpox vaccination (overall reporting rate, 217 per 10 000 Vaccinees). A total of 590 adverse events (72%) were reported within 14 days of vaccination. Nonserious adverse events (n = 722) included multiple signs and symptoms of mild and self-limited local reactions. One hundred adverse events (12%) were designated as serious, resulting in 85 hospitalizations, 2 permanent disabilities, 10 life-threatening illnesses, and 3 deaths. Among the serious adverse events, 21 cases were classified as myocarditis and/or pericarditis and 10 as ischemic cardiac events that were not anticipated based on historical data. Two cases of generalized Vaccinia and 1 case of postVaccinial encephalitis were detected. No preventable life-threatening adverse reactions, contact transmissions, or adverse reactions that required treatment with Vaccinia immune globulin were identified. Serious adverse events were more common among older reVaccinees than younger first-time Vaccinees.ConclusionsRigorous smallpox Vaccine safety screening, educational programs, and older Vaccinees may have contributed to low rates of preventable life-threatening adverse reactions. Other rare, clinically significant, or unexpected cardiac adverse events were detected by timely review of VAERS data and intensive clinical case investigation.
Jeffrey Schlom - One of the best experts on this subject based on the ideXlab platform.
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improved immunotherapy of a recombinant carcinoembryonic antigen Vaccinia Vaccine when given in combination with interleukin 2
Cancer Research, 1996Co-Authors: Joanne P Mclaughlin, Jeffrey Schlom, Judy Kantor, John W GreinerAbstract:Interleukin-2 (IL-2) has been an effective immune modulator in several active-specific immunotherapy experimental protocols using either viral or oncolysate-based Vaccines. In this report, data indicate that IL-2 administration can appreciably augment the therapeutic effect of a single immunization of a recombinant Vaccinia virus-carcinoembryonic antigen (rV-CEA) Vaccine using a CEA-expressing syngeneic experimental murine model system. A single rV-CEA immunization of C57BL/6 mice bearing palpable CEA-positive colon adenocarcinoma tumors results in complete tumor regression in approximately 20% of the mice. The addition of a course of low-dose IL-2 results in complete tumor regression in 60–70% of the mice. Moreover, the combination of rV-CEA and IL-2 induces systemic immunity, which protects those tumor-free mice from subsequent rechallenge with the CEA-expressing tumor cells. No such tumor regression or protection was observed in those mice immunized with the wild-type Vaccinia Vaccine (V-Wyeth) alone or with IL-2 administration alone. Cellular immune assays revealed that the addition of IL-2 to rV-CEA immunization significantly increased the CEA-specific T-cell proliferative responses as well as the cytolytic T-cell responses when compared with rV-CEA immunization alone. The enhanced CEA-specific immune response, coupled with the improved experimental therapeutic outcome following IL-2 administration, suggests that treatment with that cytokine may effectively substitute for multiple rV-CEA immunizations in active-specific immunotherapy clinical protocols directed at CEA-expressing tumors.
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antitumor activity and immune responses induced by a recombinant carcinoembryonic antigen Vaccinia virus Vaccine
Journal of the National Cancer Institute, 1992Co-Authors: Judy Kantor, Kari R Irvine, Scott I Abrams, Howard L Kaufman, Judy Dipietro, Jeffrey SchlomAbstract:BACKGROUND Human carcinoembryonic antigen (CEA) is a 180-kd glycoprotein expressed in human colorectal, gastric, pancreatic, breast, and non-small-cell lung carcinomas. Previous studies have demonstrated enhanced immune responses to other antigens presented with Vaccinia virus proteins via a recombinant Vaccinia virus construct. In addition, we have developed a recombinant CEA-Vaccinia virus construct, designated rV(WR)-CEA, and have demonstrated humoral anti-CEA responses in mice after immunization with that virus. PURPOSE The goals of this study were (a) to construct a recombinant CEA-Vaccinia Vaccine in a less virulent Vaccinia strain that is potentially safe and effective for treatment of patients whose tumors express CEA and (b) to evaluate the ability of the recombinant CEA-Vaccinia Vaccine to prevent and reverse tumor growth in mice and to elicit cell-mediated and humoral anti-CEA immune responses. METHODS Using the New York City strain of Vaccinia virus, which is used in smallpox vaccination and is more attenuated for humans than rV(WR), we derived a recombinant CEA-Vaccinia construct, designated rV(NYC)-CEA. The ability of this construct to induce antitumor immunity was evaluated in mice receiving subcutaneous injections of murine colon adenocarcinoma cells expressing the human CEA gene. RESULTS Administration of rV(NYC)-CEA in mice induced strong anti-CEA antibody responses, as well as CEA-specific cell-mediated responses, including delayed-type hypersensitivity, lymphoproliferative, and cytotoxic responses. Vaccination of mice with the rV(NYC)-CEA rendered them resistant to the growth of subsequently transplanted CEA-expressing tumors. Moreover, when mice were vaccinated 7 days after tumor cell injection, tumor growth was either greatly reduced or eliminated. No toxic effects were observed in any of the mice. CONCLUSION These studies demonstrate that antitumor activity can be induced with the use of a recombinant CEA-Vaccinia virus construct derived from an attenuated Vaccinia strain, and they reveal the range of cell-mediated and humoral responses induced by this recombinant Vaccine.
J A Becher - One of the best experts on this subject based on the ideXlab platform.
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Vaccinia smallpox Vaccine recommendations of the advisory committee on immunization practices acip 2001
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports Centers for Disease Control, 2001Co-Authors: L D Rotz, D A Dotson, I K Damon, J A BecherAbstract:These revised recommendations regarding Vaccinia (smallpox) Vaccine update the previous Advisory Committee on Immunization Practices (ACIP) recommendations (MMWR 1991;40; No. RR-14:1-10) and include current information regarding the nonemergency use of Vaccinia Vaccine among laboratory and health-care workers occupationally exposed to Vaccinia virus, recombinant Vaccinia viruses, and other Orthopoxviruses that can infect humans. In addition, this report contains ACIP's recommendations for the use of Vaccinia Vaccine if smallpox (variola) virus were used as an agent of biological terrorism or if a smallpox outbreak were to occur for another unforeseen reason.
Christine G Casey - One of the best experts on this subject based on the ideXlab platform.
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surveillance guidelines for smallpox Vaccine Vaccinia adverse reactions
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports Centers for Disease Control, 2006Co-Authors: Christine G Casey, Claudia Vellozzi, Gina T Mootrey, Louisa E Chapman, Mary M Mccauley, Martha H Roper, David L SwerdlowAbstract:CDC and the U.S. Food and Drug Administration rely on state and local health departments, health-care providers, and the public to report the occurrence of adverse events after vaccination to the Vaccine Adverse Event Reporting System. With such data, trends can be accurately monitored, unusual occurrences of adverse events can be detected, and the safety of vaccination intervention activities can be evaluated. On January 24, 2003, the U.S. Department of Health and Human Services (DHHS) implemented a preparedness program in which smallpox (Vaccinia) Vaccine was administered to federal, state, and local volunteers who might be first responders during a biologic terrorism event. As part of the DHHS Smallpox Preparedness and Response Program, CDC in consultation with experts, established surveillance case definitions for adverse events after smallpox vaccination. Adverse reactions after smallpox vaccination identified during the 1960s surveillance activities were classified on the basis of clinical description and included eczema vaccinatum; fetal Vaccinia; generalized Vaccinia; accidental autoinoculation, nonocular; ocular Vaccinia; progressive Vaccinia; erythema multiforme major; postVaccinial encephalitis or encephalomyelitis; and pyogenic infection of the vaccination site. This report provides uniform criteria used for the surveillance case definition and classification for these previously recognized adverse reactions used during the DHHS Smallpox Preparedness and Response Program. Inadvertent inoculation was changed to more precisely describe this event as inadvertent autoinoculation and contact transmission, nonocular and ocular Vaccinia. Pyogenic infection also was renamed superinfection of the vaccination site or regional lymph nodes. Finally, case definitions were developed for a new cardiac adverse reaction (myo/pericarditis) and for a cardiac adverse event (dilated cardiomyopathy) and are included in this report. The smallpox Vaccine surveillance case definitions presented in the report can be used in future vaccination programs to ensure uniform reporting guidelines and case classification.
Judy Kantor - One of the best experts on this subject based on the ideXlab platform.
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improved immunotherapy of a recombinant carcinoembryonic antigen Vaccinia Vaccine when given in combination with interleukin 2
Cancer Research, 1996Co-Authors: Joanne P Mclaughlin, Jeffrey Schlom, Judy Kantor, John W GreinerAbstract:Interleukin-2 (IL-2) has been an effective immune modulator in several active-specific immunotherapy experimental protocols using either viral or oncolysate-based Vaccines. In this report, data indicate that IL-2 administration can appreciably augment the therapeutic effect of a single immunization of a recombinant Vaccinia virus-carcinoembryonic antigen (rV-CEA) Vaccine using a CEA-expressing syngeneic experimental murine model system. A single rV-CEA immunization of C57BL/6 mice bearing palpable CEA-positive colon adenocarcinoma tumors results in complete tumor regression in approximately 20% of the mice. The addition of a course of low-dose IL-2 results in complete tumor regression in 60–70% of the mice. Moreover, the combination of rV-CEA and IL-2 induces systemic immunity, which protects those tumor-free mice from subsequent rechallenge with the CEA-expressing tumor cells. No such tumor regression or protection was observed in those mice immunized with the wild-type Vaccinia Vaccine (V-Wyeth) alone or with IL-2 administration alone. Cellular immune assays revealed that the addition of IL-2 to rV-CEA immunization significantly increased the CEA-specific T-cell proliferative responses as well as the cytolytic T-cell responses when compared with rV-CEA immunization alone. The enhanced CEA-specific immune response, coupled with the improved experimental therapeutic outcome following IL-2 administration, suggests that treatment with that cytokine may effectively substitute for multiple rV-CEA immunizations in active-specific immunotherapy clinical protocols directed at CEA-expressing tumors.
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antitumor activity and immune responses induced by a recombinant carcinoembryonic antigen Vaccinia virus Vaccine
Journal of the National Cancer Institute, 1992Co-Authors: Judy Kantor, Kari R Irvine, Scott I Abrams, Howard L Kaufman, Judy Dipietro, Jeffrey SchlomAbstract:BACKGROUND Human carcinoembryonic antigen (CEA) is a 180-kd glycoprotein expressed in human colorectal, gastric, pancreatic, breast, and non-small-cell lung carcinomas. Previous studies have demonstrated enhanced immune responses to other antigens presented with Vaccinia virus proteins via a recombinant Vaccinia virus construct. In addition, we have developed a recombinant CEA-Vaccinia virus construct, designated rV(WR)-CEA, and have demonstrated humoral anti-CEA responses in mice after immunization with that virus. PURPOSE The goals of this study were (a) to construct a recombinant CEA-Vaccinia Vaccine in a less virulent Vaccinia strain that is potentially safe and effective for treatment of patients whose tumors express CEA and (b) to evaluate the ability of the recombinant CEA-Vaccinia Vaccine to prevent and reverse tumor growth in mice and to elicit cell-mediated and humoral anti-CEA immune responses. METHODS Using the New York City strain of Vaccinia virus, which is used in smallpox vaccination and is more attenuated for humans than rV(WR), we derived a recombinant CEA-Vaccinia construct, designated rV(NYC)-CEA. The ability of this construct to induce antitumor immunity was evaluated in mice receiving subcutaneous injections of murine colon adenocarcinoma cells expressing the human CEA gene. RESULTS Administration of rV(NYC)-CEA in mice induced strong anti-CEA antibody responses, as well as CEA-specific cell-mediated responses, including delayed-type hypersensitivity, lymphoproliferative, and cytotoxic responses. Vaccination of mice with the rV(NYC)-CEA rendered them resistant to the growth of subsequently transplanted CEA-expressing tumors. Moreover, when mice were vaccinated 7 days after tumor cell injection, tumor growth was either greatly reduced or eliminated. No toxic effects were observed in any of the mice. CONCLUSION These studies demonstrate that antitumor activity can be induced with the use of a recombinant CEA-Vaccinia virus construct derived from an attenuated Vaccinia strain, and they reveal the range of cell-mediated and humoral responses induced by this recombinant Vaccine.