The Experts below are selected from a list of 153 Experts worldwide ranked by ideXlab platform
Donald L Lodmell - One of the best experts on this subject based on the ideXlab platform.
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Rabies Cell culture Vaccines reconstituted and stored at 4 degrees C for 1 year prior to use protect mice against rabies virus.
Vaccine, 2004Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Human exposure to rabid dogs in developing countries is an ongoing problem that continues to demand effective, safe, and affordable post-exposure rabies vaccinations. Sheep and suckling mouse brain rabies Vaccines used in developing countries are being replaced by expensive inactivated-virus Cell culture Vaccines. Human studies using Cell culture Vaccines have determined that cost is reduced and protection is maintained by injecting the unused portion of Vaccines that have been reconstituted and stored refrigerated for 1 week. Here we determined whether reconstituted purified chick embryo Cell and human Diploid Cell Vaccine that had been stored at 4 degrees C for intervals up to 1 year elicit neutralizing antibody, and protect mice against rabies virus. Undiluted, or 1:5 and 1:25 dilutions of both Vaccines injected immediately after reconstitution, or after reconstitution and storage at 4 degrees C for 1 week, 1 month, 3 months, 6 months or 1 year elicited high levels of neutralizing antibody and protected 100% of the mice injected with rabies virus.
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Rabies Cell culture Vaccines reconstituted and stored at 4 °C for 1 year prior to use protect mice against rabies virus
Vaccine, 2004Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Abstract Human exposure to rabid dogs in developing countries is an ongoing problem that continues to demand effective, safe, and affordable post-exposure rabies vaccinations. Sheep and suckling mouse brain rabies Vaccines used in developing countries are being replaced by expensive inactivated-virus Cell culture Vaccines. Human studies using Cell culture Vaccines have determined that cost is reduced and protection is maintained by injecting the unused portion of Vaccines that have been reconstituted and stored refrigerated for 1 week. Here we determined whether reconstituted purified chick embryo Cell and human Diploid Cell Vaccine that had been stored at 4 °C for intervals up to 1 year elicit neutralizing antibody, and protect mice against rabies virus. Undiluted, or 1:5 and 1:25 dilutions of both Vaccines injected immediately after reconstitution, or after reconstitution and storage at 4 °C for 1 week, 1 month, 3 months, 6 months or 1 year elicited high levels of neutralizing antibody and protected 100% of the mice injected with rabies virus.
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Rabies DNA vaccination of non-human primates: post-exposure studies using gene gun methodology that accelerates induction of neutralizing antibody and enhances neutralizing antibody titers.
Vaccine, 2002Co-Authors: Donald L Lodmell, Larry C Ewalt, Michael J Parnell, John R Bailey, Cathleen A HanlonAbstract:Pre-exposure DNA vaccination protects non-human primates against rabies virus. Post-exposure protection of monkeys against rabies virus by DNA vaccination has not been attempted. Presumably, post-exposure experiments have not been undertaken because neutralizing antibody is usually slow to be induced after DNA vaccination. In this study, we initially attempted to accelerate the induction of neutralizing antibody by varying the route and site of DNA vaccination and booster frequency. Gene gun (GG) vaccinations above axillary and inguinal lymph nodes or in ear pinnae generated higher levels of neutralizing antibody than intradermal (ID) needle vaccinations in the pinnae. Concurrent GG booster vaccinations above axillary and inguinal lymph nodes and in ear pinnae, 3 days after primary vaccination, accelerated detectable neutralizing antibody. GG booster vaccinations also resulted in higher neutralizing antibody levels and increased the durability of this response. Post-exposure vaccination with DNA or the human Diploid Cell Vaccine (HDCV), in combination with an one-time treatment with human rabies immune globulin (HRIG), protected 50 and 75% of the monkeys, respectively, as compared to 75% mortality of the controls. These data will be useful for the refinement, development, and implementation of future pre- and post-exposure rabies DNA vaccination studies.
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Post-exposure DNA vaccination protects mice against rabies virus.
Vaccine, 2001Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Post-exposure anti-rabies vaccination for individuals who have not previously been immunized against rabies includes a Cell culture-derived Vaccine and a one time injection of rabies immune globulin. Recent studies have shown DNA vaccinations to be highly effective in rabies pre-exposure experiments, but post-exposure protection has not been achieved. This failure is likely due to the slow onset of DNA Vaccine induced antibody production. In an attempt to accelerate the onset of the antibody response, we manipulated variables, such as the route of vaccination and booster frequency. Anti-rabies virus antibody was detected 5 days after the initial DNA vaccination. Using this vaccination protocol and a single non-protective dose of anti-rabies immune serum, we questioned whether mice injected 6 h previously with rabies virus would be protected if a DNA Vaccine was substituted for the Cell culture-derived human Diploid Cell Vaccine (HDCV). The DNA Vaccine protected 87% of the mice (P=0.00005, compared with unvaccinated control mice). Some 75% of mice receiving HDCV were protected (P=0.00097, compared with unvaccinated control mice). Mice receiving only anti-rabies immune serum were not protected (P>0.05 compared to unvaccinated control mice). Thus, post-exposure therapy, substituting a DNA Vaccine for HDCV, did not compromise protection against rabies virus.
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Rabies vaccination: comparison of neutralizing antibody responses after priming and boosting with different combinations of DNA, inactivated virus, or recombinant vaccinia virus Vaccines.
Vaccine, 2000Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Abstract Long-term levels of neutralizing antibody were evaluated in mice after a single immunization with experimental DNA or recombinant vaccinia virus (RVV) Vaccines encoding the rabies virus glycoprotein (G), or the commercially available inactivated virus human Diploid Cell Vaccine (HDCV). Anamnestic antibody titers were also evaluated after two booster immunizations with Vaccines that were identical to or different from the priming Vaccine. Five hundred and forty days (1.5 year) after a single immunization with any of the three Vaccines, neutralizing antibody titers remained greater than the minimal acceptable human level of antibody titer (0.5 International Units (IU)/ml). In addition, either an HDCV or DNA booster elicited early and elevated anamnestic antibody responses in mice that had been primed with any of the three Vaccines. In contrast, RVV boosters failed to elevate titers in mice that had been previously primed with RVV, and elicited slowly rising titers in mice that had been primed with either DNA or HDCV. Thus, a single vaccination with any of the three different Vaccines elicited long-term levels of neutralizing antibody that exceeded 0.5 IU/ml. In contrast, different prime–booster Vaccine combinations elicited anamnestic neutralizing antibody responses that increased quickly, increased slowly or failed to increase.
Maria Cano - One of the best experts on this subject based on the ideXlab platform.
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Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015
PLoS neglected tropical diseases, 2016Co-Authors: Pedro L. Moro, Emily Jane Woo, Wendy Paul, Paige Lewis, Brett W. Petersen, Maria CanoAbstract:Background In 1980, human Diploid Cell Vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.
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Characteristics of human Diploid Cell Vaccine (HDCV, Imovax) rabies Vaccine reports to VAERS among persons vaccinated January 1, 1990 through July 31, 2015.
2016Co-Authors: Pedro L. Moro, Emily Jane Woo, Wendy Paul, Paige Lewis, Brett W. Petersen, Maria CanoAbstract:Characteristics of human Diploid Cell Vaccine (HDCV, Imovax) rabies Vaccine reports to VAERS among persons vaccinated January 1, 1990 through July 31, 2015.
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Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.
Public Library of Science (PLoS), 2016Co-Authors: Pedro L. Moro, Emily Jane Woo, Wendy Paul, Paige Lewis, Brett W. Petersen, Maria CanoAbstract:BACKGROUND:In 1980, human Diploid Cell Vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. OBJECTIVE:To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS:We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. RESULTS:VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. CONCLUSIONS:This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies
Larry C Ewalt - One of the best experts on this subject based on the ideXlab platform.
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Rabies Cell culture Vaccines reconstituted and stored at 4 degrees C for 1 year prior to use protect mice against rabies virus.
Vaccine, 2004Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Human exposure to rabid dogs in developing countries is an ongoing problem that continues to demand effective, safe, and affordable post-exposure rabies vaccinations. Sheep and suckling mouse brain rabies Vaccines used in developing countries are being replaced by expensive inactivated-virus Cell culture Vaccines. Human studies using Cell culture Vaccines have determined that cost is reduced and protection is maintained by injecting the unused portion of Vaccines that have been reconstituted and stored refrigerated for 1 week. Here we determined whether reconstituted purified chick embryo Cell and human Diploid Cell Vaccine that had been stored at 4 degrees C for intervals up to 1 year elicit neutralizing antibody, and protect mice against rabies virus. Undiluted, or 1:5 and 1:25 dilutions of both Vaccines injected immediately after reconstitution, or after reconstitution and storage at 4 degrees C for 1 week, 1 month, 3 months, 6 months or 1 year elicited high levels of neutralizing antibody and protected 100% of the mice injected with rabies virus.
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Rabies Cell culture Vaccines reconstituted and stored at 4 °C for 1 year prior to use protect mice against rabies virus
Vaccine, 2004Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Abstract Human exposure to rabid dogs in developing countries is an ongoing problem that continues to demand effective, safe, and affordable post-exposure rabies vaccinations. Sheep and suckling mouse brain rabies Vaccines used in developing countries are being replaced by expensive inactivated-virus Cell culture Vaccines. Human studies using Cell culture Vaccines have determined that cost is reduced and protection is maintained by injecting the unused portion of Vaccines that have been reconstituted and stored refrigerated for 1 week. Here we determined whether reconstituted purified chick embryo Cell and human Diploid Cell Vaccine that had been stored at 4 °C for intervals up to 1 year elicit neutralizing antibody, and protect mice against rabies virus. Undiluted, or 1:5 and 1:25 dilutions of both Vaccines injected immediately after reconstitution, or after reconstitution and storage at 4 °C for 1 week, 1 month, 3 months, 6 months or 1 year elicited high levels of neutralizing antibody and protected 100% of the mice injected with rabies virus.
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Rabies DNA vaccination of non-human primates: post-exposure studies using gene gun methodology that accelerates induction of neutralizing antibody and enhances neutralizing antibody titers.
Vaccine, 2002Co-Authors: Donald L Lodmell, Larry C Ewalt, Michael J Parnell, John R Bailey, Cathleen A HanlonAbstract:Pre-exposure DNA vaccination protects non-human primates against rabies virus. Post-exposure protection of monkeys against rabies virus by DNA vaccination has not been attempted. Presumably, post-exposure experiments have not been undertaken because neutralizing antibody is usually slow to be induced after DNA vaccination. In this study, we initially attempted to accelerate the induction of neutralizing antibody by varying the route and site of DNA vaccination and booster frequency. Gene gun (GG) vaccinations above axillary and inguinal lymph nodes or in ear pinnae generated higher levels of neutralizing antibody than intradermal (ID) needle vaccinations in the pinnae. Concurrent GG booster vaccinations above axillary and inguinal lymph nodes and in ear pinnae, 3 days after primary vaccination, accelerated detectable neutralizing antibody. GG booster vaccinations also resulted in higher neutralizing antibody levels and increased the durability of this response. Post-exposure vaccination with DNA or the human Diploid Cell Vaccine (HDCV), in combination with an one-time treatment with human rabies immune globulin (HRIG), protected 50 and 75% of the monkeys, respectively, as compared to 75% mortality of the controls. These data will be useful for the refinement, development, and implementation of future pre- and post-exposure rabies DNA vaccination studies.
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Post-exposure DNA vaccination protects mice against rabies virus.
Vaccine, 2001Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Post-exposure anti-rabies vaccination for individuals who have not previously been immunized against rabies includes a Cell culture-derived Vaccine and a one time injection of rabies immune globulin. Recent studies have shown DNA vaccinations to be highly effective in rabies pre-exposure experiments, but post-exposure protection has not been achieved. This failure is likely due to the slow onset of DNA Vaccine induced antibody production. In an attempt to accelerate the onset of the antibody response, we manipulated variables, such as the route of vaccination and booster frequency. Anti-rabies virus antibody was detected 5 days after the initial DNA vaccination. Using this vaccination protocol and a single non-protective dose of anti-rabies immune serum, we questioned whether mice injected 6 h previously with rabies virus would be protected if a DNA Vaccine was substituted for the Cell culture-derived human Diploid Cell Vaccine (HDCV). The DNA Vaccine protected 87% of the mice (P=0.00005, compared with unvaccinated control mice). Some 75% of mice receiving HDCV were protected (P=0.00097, compared with unvaccinated control mice). Mice receiving only anti-rabies immune serum were not protected (P>0.05 compared to unvaccinated control mice). Thus, post-exposure therapy, substituting a DNA Vaccine for HDCV, did not compromise protection against rabies virus.
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Rabies vaccination: comparison of neutralizing antibody responses after priming and boosting with different combinations of DNA, inactivated virus, or recombinant vaccinia virus Vaccines.
Vaccine, 2000Co-Authors: Donald L Lodmell, Larry C EwaltAbstract:Abstract Long-term levels of neutralizing antibody were evaluated in mice after a single immunization with experimental DNA or recombinant vaccinia virus (RVV) Vaccines encoding the rabies virus glycoprotein (G), or the commercially available inactivated virus human Diploid Cell Vaccine (HDCV). Anamnestic antibody titers were also evaluated after two booster immunizations with Vaccines that were identical to or different from the priming Vaccine. Five hundred and forty days (1.5 year) after a single immunization with any of the three Vaccines, neutralizing antibody titers remained greater than the minimal acceptable human level of antibody titer (0.5 International Units (IU)/ml). In addition, either an HDCV or DNA booster elicited early and elevated anamnestic antibody responses in mice that had been primed with any of the three Vaccines. In contrast, RVV boosters failed to elevate titers in mice that had been previously primed with RVV, and elicited slowly rising titers in mice that had been primed with either DNA or HDCV. Thus, a single vaccination with any of the three different Vaccines elicited long-term levels of neutralizing antibody that exceeded 0.5 IU/ml. In contrast, different prime–booster Vaccine combinations elicited anamnestic neutralizing antibody responses that increased quickly, increased slowly or failed to increase.
Pedro L. Moro - One of the best experts on this subject based on the ideXlab platform.
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Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015
PLoS neglected tropical diseases, 2016Co-Authors: Pedro L. Moro, Emily Jane Woo, Wendy Paul, Paige Lewis, Brett W. Petersen, Maria CanoAbstract:Background In 1980, human Diploid Cell Vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. Objective To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990–July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.
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Characteristics of human Diploid Cell Vaccine (HDCV, Imovax) rabies Vaccine reports to VAERS among persons vaccinated January 1, 1990 through July 31, 2015.
2016Co-Authors: Pedro L. Moro, Emily Jane Woo, Wendy Paul, Paige Lewis, Brett W. Petersen, Maria CanoAbstract:Characteristics of human Diploid Cell Vaccine (HDCV, Imovax) rabies Vaccine reports to VAERS among persons vaccinated January 1, 1990 through July 31, 2015.
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Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.
Public Library of Science (PLoS), 2016Co-Authors: Pedro L. Moro, Emily Jane Woo, Wendy Paul, Paige Lewis, Brett W. Petersen, Maria CanoAbstract:BACKGROUND:In 1980, human Diploid Cell Vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. OBJECTIVE:To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS:We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. RESULTS:VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. CONCLUSIONS:This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies
Deborah J. Briggs - One of the best experts on this subject based on the ideXlab platform.
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Use of a reduced (4-dose) Vaccine schedule for postexposure prophylaxis to prevent human rabies; recommendations of the Advisory Committee on Immunization Practices
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports, 2010Co-Authors: Charles E. Rupprecht, Deborah J. Briggs, Catherine M. Brown, Richard Franka, Samuel L. Katz, Harry D. Kerr, Susan M. Lett, Robin Levis, Martin I. Meltzer, Charles E Rupprecht, William SchaffnerAbstract:This report summarizes new recommendation and updates previous recommendations of the Advisory Committee on Immunization Practices (ACIP) for postexposure prophylaxis (PEP) to prevent human rabies (CDC. Human rabies prevention---United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR 2008;57[No. RR-3]). Previously, ACIP recommended a 5-dose rabies vaccination regimen with human Diploid Cell Vaccine (HDCV) or purified chick embryo Cell Vaccine (PCECV). These new recommendations reduce the number of Vaccine doses to four. The reduction in doses recommended for PEP was based in part on evidence from rabies virus pathogenesis data, experimental animal work, clinical studies, and epidemiologic surveillance. These studies indicated that 4 Vaccine doses in combination with rabies immune globulin (RIG) elicited adequate immune responses and that a fifth dose of Vaccine did not contribute to more favorable outcomes. For persons previously unvaccinated with rabies Vaccine, the reduced regimen of 4 1-mL doses of HDCV or PCECV should be administered intramuscularly. The first dose of the 4-dose course should be administered as soon as possible after exposure (day 0). Additional doses then should be administered on days 3, 7, and 14 after the first vaccination. ACIP recommendations for the use of RIG remain unchanged. For persons who previously received a complete vaccination series (pre- or postexposure prophylaxis) with a Cell-culture Vaccine or who previously had a documented adequate rabies virus-neutralizing antibody titer following vaccination with nonCell-culture Vaccine, the recommendation for a 2-dose PEP vaccination series has not changed. Similarly, the number of doses recommended for persons with altered immunocompetence has not changed; for such persons, PEP should continue to comprise a 5-dose vaccination regimen with 1 dose of RIG. Recommendations for pre-exposure prophylaxis also remain unchanged, with 3 doses of Vaccine administered on days 0, 7, and 21 or 28. Prompt rabies PEP combining wound care, infiltration of RIG into and around the wound, and multiple doses of rabies Cell-culture Vaccine continue to be highly effective in preventing human rabies.
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Human rabies prevention--United States, 2008 : recommendations of the Advisory Committee on Immunization Practices
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports, 2008Co-Authors: Deborah J. Briggs, Catherine M. Brown, Richard Franka, Samuel L. Katz, Harry D. Kerr, Susan M. Lett, Robin Levis, Martin I. Meltzer, Paul R. Cieslak, Charles E RupprechtAbstract:These recommendations of the Advisory Committee on Immunization Practices (ACIP) update the previous recommendations on human rabies prevention (CDC. Human rabies prevention--United States, 1999: recommendations of the Advisory Committee on Immunization Practices. MMWR 1999;48 [No. RR-1]) and reflect the status of rabies and antirabies biologics in the United States. This statement 1) provides updated information on human and animal rabies epidemiology; 2) summarizes the evidence regarding the effectiveness/efficacy, immunogenicity, and safety of rabies biologics; 3) presents new information on the cost-effectiveness of rabies postexposure prophylaxis; 4) presents recommendations for rabies postexposure and pre-exposure prophylaxis; and 5) presents information regarding treatment considerations for human rabies patients. These recommendations involve no substantial changes to the recommended approach for rabies postexposure or pre-exposure prophylaxis. ACIP recommends that prophylaxis for the prevention of rabies in humans exposed to rabies virus should include prompt and thorough wound cleansing followed by passive rabies immunization with human rabies immune globulin (HRIG) and vaccination with a Cell culture rabies Vaccine. For persons who have never been vaccinated against rabies, postexposure antirabies vaccination should always include administration of both passive antibody (HRIG) and Vaccine (human Diploid Cell Vaccine [HDCV] or purified chick embryo Cell Vaccine [PCECV]). Persons who have ever previously received complete vaccination regimens (pre-exposure or postexposure) with a Cell culture Vaccine or persons who have been vaccinated with other types of Vaccines and have previously had a documented rabies virus neutralizing antibody titer should receive only 2 doses of Vaccine: one on day 0 (as soon as the exposure is recognized and administration of Vaccine can be arranged) and the second on day 3. HRIG is administered only once (i.e., at the beginning of antirabies prophylaxis) to previously unvaccinated persons to provide immediate, passive, rabies virus neutralizing antibody coverage until the patient responds to HDCV or PCECV by actively producing antibodies. A regimen of 5 1-mL doses of HDCV or PCECV should be administered intramuscularly to previously unvaccinated persons. The first dose of the 5-dose course should be administered as soon as possible after exposure (day 0). Additional doses should then be administered on days 3, 7, 14, and 28 after the first vaccination. Rabies pre-exposure vaccination should include three 1.0-mL injections of HDCV or PCECV administered intramuscularly (one injection per day on days 0, 7, and 21 or 28). Modifications were made to the language of the guidelines to clarify the recommendations and better specify the situations in which rabies post- and pre-exposure prophylaxis should be administered. No new rabies biologics are presented, and no changes were made to the vaccination schedules. However, rabies Vaccine adsorbed (RVA, Bioport Corporation) is no longer available for rabies postexposure or pre-exposure prophylaxis, and intradermal pre-exposure prophylaxis is no longer recommended because it is not available in the United States.
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immunogenicity safety and lot consistency in adults of a chromatographically purified vero Cell rabies Vaccine a randomized double blind trial with human Diploid Cell rabies Vaccine
Vaccine, 2001Co-Authors: Robert L Jones, Larry Moeller, James E. Froeschle, Robert L Atmar, Stephen J Matthews, Ronald Sanders, John Pardalos, Jean E Chin, Michelle Famula, Deborah J. BriggsAbstract:The immunogenicity and safety of a chromatographically purified rabies Vaccine (CPRV) was evaluated using US veterinary medical students. In the first study, 242 healthy adults were enrolled in a randomized, modified double-blind, multicenter trial and received five doses of either CPRV or human Diploid Cell Vaccine (HDCV) by intramuscular injection on days 0, 3, 7, 14, and 28 concurrently with human rabies immunoglobulin in a simulated post-exposure prophylaxis regimen. Post-immunization titers in the CPRV and HDCV groups reached 0.5 IU/ml (the WHO-recommended minimally acceptable titer) or greater in all subjects in both Vaccine groups by day 14 and remained above that level through day 90. In the second study, 438 healthy adults were enrolled in a randomized, double-blind, multicenter trial and assigned to receive five doses from one of three lots of CPRV by intramuscular injection on days 0, 3, 7, 14, and 28 in a simulated post-exposure prophylaxis regimen to evaluate lot consistency. Post-immunization titers rapidly increased to over 0.5 IU/ml by day 14 for all subjects and remained above that level through day 42 when the study was terminated. The three lots were considered equivalent. The percentage of subjects with at least one local reaction during the five-dose regimen was slightly lower in the CPRV group than in the HDCV group (P=0.06). The most frequently reported local reaction for all doses of Vaccine was pain at the injection site. Headache, myalgia, and malaise were the most frequently reported systemic events. The percentage of subjects with at least one systemic event was significantly lower for CPRV (P=0.0084). No Vaccine-related serious adverse reaction was reported in these studies. The results of these studies indicate that CPRV administered intramuscularly to healthy adults is immunogenic and is associated with fewer local and systemic reactions than HDCV.