Japanese Encephalitis Vaccine

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Susan L Hills - One of the best experts on this subject based on the ideXlab platform.

  • Japanese Encephalitis Vaccine recommendations of the advisory committee on immunization practices
    MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports, 2019
    Co-Authors: Susan L Hills, Emmanuel B Walter, Robert L Atmar, Marc Fischer
    Abstract:

    This report updates the 2010 recommendations from the CDC Advisory Committee on Immunization Practices (ACIP) regarding prevention of Japanese Encephalitis (JE) among U.S. travelers and laboratory workers (Fischer M, Lindsey N, Staples JE, Hills S. Japanese Encephalitis Vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2010;59[No. RR-1]). The report summarizes the epidemiology of JE, describes the JE Vaccine that is licensed and available in the United States, and provides recommendations for its use among travelers and laboratory workers.JE virus, a mosquitoborne flavivirus, is the most common Vaccine-preventable cause of Encephalitis in Asia. JE occurs throughout most of Asia and parts of the western Pacific. Approximately 20%-30% of patients die, and 30%-50% of survivors have neurologic, cognitive, or behavioral sequelae. No antiviral treatment is available.Inactivated Vero cell culture-derived JE Vaccine (Ixiaro [JE-VC]) is the only JE Vaccine that is licensed and available in the United States. In 2009, the U.S. Food and Drug Administration (FDA) licensed JE-VC for use in persons aged ≥17 years; in 2013, licensure was extended to include children aged ≥2 months.Most travelers to countries where the disease is endemic are at very low risk for JE. However, some travelers are at increased risk for infection on the basis of their travel plans. Factors that increase the risk for JE virus exposure include 1) traveling for a longer period; 2) travel during the JE virus transmission season; 3) spending time in rural areas; 4) participating in extensive outdoor activities; and 5) staying in accommodations without air conditioning, screens, or bed nets. All travelers to countries where JE is endemic should be advised to take precautions to avoid mosquito bites to reduce the risk for JE and other vectorborne diseases. For some persons who might be at increased risk for JE, the Vaccine can further reduce the risk for infection. The decision about whether to vaccinate should be individualized and consider the 1) risks related to the specific travel itinerary, 2) likelihood of future travel to countries where JE is endemic, 3) high morbidity and mortality of JE, 4) availability of an effective Vaccine, 5) possibility (but low probability) of serious adverse events after vaccination, and 6) the traveler's personal perception and tolerance of risk.JE Vaccine is recommended for persons moving to a JE-endemic country to take up residence, longer-term (e.g., ≥1 month) travelers to JE-endemic areas, and frequent travelers to JE-endemic areas. JE Vaccine also should be considered for shorter-term (e.g., <1 month) travelers with an increased risk for JE on the basis of planned travel duration, season, location, activities, and accommodations and for travelers to JE-endemic areas who are uncertain about their specific travel duration, destinations, or activities. JE Vaccine is not recommended for travelers with very low-risk itineraries, such as shorter-term travel limited to urban areas or outside of a well-defined JE virus transmission season.

  • adverse events following vaccination with an inactivated vero cell culture derived Japanese Encephalitis Vaccine in the united states 2012 2016
    Vaccine, 2018
    Co-Authors: William L Walker, Susan L Hills, Elaine R Miller, Marc Fischer, Ingrid B Rabe
    Abstract:

    Abstract Background In March 2009, the U.S. Food and Drug Administration licensed an inactivated Vero cell culture-derived Japanese Encephalitis Vaccine (JE-VC [IXIARO®]) for use in persons aged ≥17 years. In 2013, licensure was extended to include children aged ≥2 months. A previous analysis reviewed adverse events reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from May 2009 through April 2012. Methods We reviewed adverse events reported to VAERS following JE-VC administered from May 1, 2012 through April 30, 2016. Adverse event reporting rates were calculated using 802,229 doses distributed. Results During the 4-year period, 119 adverse event reports were received for a reporting rate of 14.8 per 100,000 doses distributed. Nine (8%) adverse events were classified as serious for a reporting rate of 1.1 per 100,000 distributed. The most commonly reported event was hypersensitivity ( n  = 24; 20%) for a rate of 3.0 per 100,000 doses distributed; 1 anaphylaxis event was reported. Ten (8%) neurologic events were reported for a rate of 1.2 per 100,000 doses distributed; 2 events were classified as seizures. Sixty-three (53%) adverse events occurred after a first dose of JE-VC. Eighty (67%) adverse events occurred after administration of JE-VC with other Vaccines. Eleven (9%) adverse events were reported in children; 1 was considered serious. Conclusions These data continue to support the generally favorable safety profile of JE-VC. Reporting rates of adverse events were similar to those of the previous analysis. Although reporting rates of adverse events in children could not be calculated, there were low numbers of reported events in this age group. Post-licensure adverse event surveillance for this relatively new Vaccine continues to be important to monitor adverse event reporting rates and identify possible rare serious events.

  • adverse events following vaccination with an inactivated vero cell culture derived Japanese Encephalitis Vaccine in the united states 2009 2012
    Vaccine, 2015
    Co-Authors: Ingrid B Rabe, Elaine R Miller, Marc Fischer, Susan L Hills
    Abstract:

    Background In March 2009, the U.S. Food and Drug Administration licensed an inactivated, Vero cell culture-derived Japanese Encephalitis Vaccine (JE-VC [Ixiaro]) for use in adults. The Vaccine was licensed based on clinical trial safety data in 3558 JE-VC recipients. It is essential to monitor post-licensure surveillance data to evaluate the safety of JE-VC because rare adverse events may not be detected until the Vaccine is administered to a larger population.

  • lot to lot consistency of live attenuated sa 14 14 2 Japanese Encephalitis Vaccine manufactured in a good manufacturing practice facility and non inferiority with respect to an earlier product
    Vaccine, 2014
    Co-Authors: K Zaman, Amy Sarah Ginsburg, Mansour Yaich, Lei Zhang, Abu Mohd Naser, Maureen Power, Stephen P Luby, Mahmudur Rahman, Susan L Hills
    Abstract:

    We conducted a four-arm, double-blind, randomized controlled trial among 818 Bangladeshi infants between 10 and 12 months of age to establish equivalence among three lots of live attenuated SA 14-14-2 JE Vaccine manufactured by the China National Biotec Group's Chengdu Institute of Biological Products (CDIBP) in a new Good Manufacturing Practice (GMP) facility and to evaluate non-inferiority of the product with a lot of the same Vaccine manufactured in CDIBP's original facility. The study took place in two sites in Bangladesh, rural Matlab and Mirpur in urban Dhaka. We collected pre-vaccination (Day 0) and post-vaccination Day 28 (-4 to +14 days) blood samples to assess neutralizing anti-JE virus antibody titers in serum by plaque reduction neutralization tests (PRNT). Seroprotection following vaccination was defined as a PRNT titer ≥1:10 at Day 28 in participants non-immune at baseline. Follow-up for reactogenicity and safety was conducted through home visits at Day 7 and monitoring for serious adverse events through Day 28. Seroprotection rates ranged from 80.2% to 86.3% for all four lots of Vaccine. Equivalence of the seroprotection rates between pairs of Vaccine lots produced in the new GMP facility was satisfied at the pre-specified 10% margin of the 95% confidence interval (CI) for two of the three pairwise comparisons, but not for the third (-4.3% observed difference with 95% CI of -11.9 to 3.3%). Nevertheless, the aggregate seroprotection rate for all three Vaccine lots manufactured in the GMP facility was calculated and found to be within the non-inferiority margin (within 10%) to the Vaccine lot produced in the original facility. All four lots of Vaccine were safe and well tolerated. These study results should facilitate the use of SA 14-14-2 JE Vaccine as a routine component of immunization programs in Asian countries.

  • use of Japanese Encephalitis Vaccine in us travel medicine practices in global travepinet
    American Journal of Tropical Medicine and Hygiene, 2014
    Co-Authors: Bhushan R Deshpande, Susan L Hills, Marc Fischer, Sowmya R Rao, Emily S Jentes, Mark D Gershman, Gary W Brunette, Edward T Ryan, Regina C Larocque
    Abstract:

    Few data regarding the use of Japanese Encephalitis (JE) Vaccine in clinical practice are available. We identified 711 travelers at higher risk and 7,578 travelers at lower risk for JE who were seen at US Global TravEpiNet sites from September of 2009 to August of 2012. Higher-risk travelers were younger than lower-risk travelers (median age = 29 years versus 40 years, P < 0.001). Over 70% of higher-risk travelers neither received JE Vaccine during the clinic visit nor had been previously vaccinated. In the majority of these instances, clinicians determined that the JE Vaccine was not indicated for the higher-risk traveler, which contradicts current recommendations of the Advisory Committee on Immunization Practices. Better understanding is needed of the clinical decision-making regarding JE Vaccine in US travel medicine practices.

Elisabeth Schuller - One of the best experts on this subject based on the ideXlab platform.

  • safety analysis of a vero cell culture derived Japanese Encephalitis Vaccine ixiaro ic51 in 6 months of follow up
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Bernd Jilma, Anton Klingler, Elisabeth Schuller
    Abstract:

    Abstract Japanese Encephalitis (JE) is the most common viral Encephalitis in Asia. IXIARO ® is a Vero cell-derived, inactivated JE virus Vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO ® , for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO ® vaccination, 435 subjects with a JE-VAX ® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH) 3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO ® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO ® ; 40% PBS + Alum vaccination). JE-VAX ® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO ® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX ® (64%); as for subjects with serious AEs (1% IXIARO ® ; 2% PBS + Alum vaccination, 1% JE-VAX ® ). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO ® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX ® .

  • safety analysis of a vero cell culture derived Japanese Encephalitis Vaccine ixiaro ic51 in 6 months of follow up
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Bernd Jilma, Anton Klingler, Elisabeth Schuller
    Abstract:

    Abstract Japanese Encephalitis (JE) is the most common viral Encephalitis in Asia. IXIARO ® is a Vero cell-derived, inactivated JE virus Vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO ® , for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO ® vaccination, 435 subjects with a JE-VAX ® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH) 3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO ® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO ® ; 40% PBS + Alum vaccination). JE-VAX ® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO ® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX ® (64%); as for subjects with serious AEs (1% IXIARO ® ; 2% PBS + Alum vaccination, 1% JE-VAX ® ). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO ® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX ® .

  • long term immunity and immune response to a booster dose following vaccination with the inactivated Japanese Encephalitis Vaccine ixiaro ic51
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Susanne Eder, Elisabeth Schuller, Erich Tauber, Vera Buerger, Gabriele Gartnerwoelfl, Christoph Klade
    Abstract:

    Abstract IC51 (IXIARO ® , JESPECT ® ) is a recently approved prophylactic Japanese Encephalitis virus Vaccine with a two-Vaccine primary immunization regimen. In this phase 3 trial, after primary immunization with a Day 0/28 dose schedule, seroprotection rates were 83%, 58% and 48% at Month 6, Month 12 and Month 24, respectively. A booster dose at Month 11 and/or Month 23 in subjects with neutralizing antibody titers below the limit of detection (defined as a serum dilution giving a 50% reduction of plaque counts in a plaque reduction neutralization test [PRNT50]

  • long term immunity and immune response to a booster dose following vaccination with the inactivated Japanese Encephalitis Vaccine ixiaro ic51
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Susanne Eder, Elisabeth Schuller, Erich Tauber, Vera Buerger, Gabriele Gartnerwoelfl, Christoph Klade
    Abstract:

    IC51 (IXIARO, JESPECT) is a recently approved prophylactic Japanese Encephalitis virus Vaccine with a two-Vaccine primary immunization regimen. In this phase 3 trial, after primary immunization with a Day 0/28 dose schedule, seroprotection rates were 83%, 58% and 48% at Month 6, Month 12 and Month 24, respectively. A booster dose at Month 11 and/or Month 23 in subjects with neutralizing antibody titers below the limit of detection (defined as a serum dilution giving a 50% reduction of plaque counts in a plaque reduction neutralization test [PRNT50]<1:10) led to 100% seroconversion. After a single-dose immunization (incomplete primary immunization), only 9% of subjects were seroprotected at Month 6; however, a booster dose at Month 11 led to seroconversion in 99% of subjects. Hence, subjects with incomplete primary immunization can complete their schedule within at least 11 months.

  • comparison of a single high dose vaccination regimen to the standard regimen for the investigational Japanese Encephalitis Vaccine ic51 a randomized observer blind controlled phase 3 study
    Vaccine, 2009
    Co-Authors: Elisabeth Schuller, Christoph Klade, Gabriele Wolfl, A Kaltenbock, Shailesh Dewasthaly, Erich Tauber
    Abstract:

    The standard administration of the investigational Japanese Encephalitis Vaccine IC51 is 2 doses of 6 microg with a 28-day interval. This study investigated the immunogenicity of a single-immunization, high-dose regimen (1 x 12 microg) compared to the 2-injection, standard regimen to determine the immune response that one, high-dose injection can confer. The single, high-dose regimen resulted in about 60% seroconversion rate (SCR) at 10 days after administration, but it did not reach the almost 100% SCR achieved by the 2-dose standard administration at Day 35. The standard regimen conferred essentially 100% seroconversion already 7 days after the second immunization.

Katrin Dubischarkastner - One of the best experts on this subject based on the ideXlab platform.

  • long term immunity following a booster dose of the inactivated Japanese Encephalitis Vaccine ixiaro ic51
    Vaccine, 2011
    Co-Authors: Susanne Eder, Michael Knappik, Christa Firbas, Katrin Dubischarkastner, Astrid Kaltenboeck, Herwig Kollaritsch, Bernd Jilma, Tomas Jelinek, Michael Kundi, Maria Paulkekorinek
    Abstract:

    Abstract Introduction IXIARO (IC51), a recently approved inactivated Japanese Encephalitis Vaccine, is immunogenic and safe in a 0/28 days primary immunization schedule. Neutralizing antibody titers decline with time and booster doses are likely needed to enhance persistence of immunity. Objectives To assess the effect of a booster dose on neutralizing JE antibody titers for up to 12 months after boostering. Methods In this phase III trial, 198 subjects, who had received primary immunization in a preceding randomized trial, were boosted with IXIARO 15 months after the primary immunization. Neutralizing antibody titers were assessed by plaque-reduction neutralisation test, PRNT. Results Prior to the booster dose, 69.2% (137/198) of subjects had PRNT50 titers ≥1:10. One month after the booster, the rate of subjects with PRNT50 ≥ 1:10 (recognized as a protective titer) was 100%. This rate remained high at 98.5% at 6 and 12 months; GMTs were 22.5 before the booster and 900, 487 and 361 at 1, 6 and 12 months after the booster, respectively. Conclusion A booster dose of IXIARO at 15 months after primary immunization was highly immunogenic with GMTs >5-fold higher than those seen immediately after primary immunization, and remained at high levels for at least 12 months after the booster. NCT00595309 .

  • safety analysis of a vero cell culture derived Japanese Encephalitis Vaccine ixiaro ic51 in 6 months of follow up
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Bernd Jilma, Anton Klingler, Elisabeth Schuller
    Abstract:

    Abstract Japanese Encephalitis (JE) is the most common viral Encephalitis in Asia. IXIARO ® is a Vero cell-derived, inactivated JE virus Vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO ® , for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO ® vaccination, 435 subjects with a JE-VAX ® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH) 3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO ® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO ® ; 40% PBS + Alum vaccination). JE-VAX ® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO ® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX ® (64%); as for subjects with serious AEs (1% IXIARO ® ; 2% PBS + Alum vaccination, 1% JE-VAX ® ). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO ® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX ® .

  • safety analysis of a vero cell culture derived Japanese Encephalitis Vaccine ixiaro ic51 in 6 months of follow up
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Bernd Jilma, Anton Klingler, Elisabeth Schuller
    Abstract:

    Abstract Japanese Encephalitis (JE) is the most common viral Encephalitis in Asia. IXIARO ® is a Vero cell-derived, inactivated JE virus Vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO ® , for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO ® vaccination, 435 subjects with a JE-VAX ® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH) 3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO ® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO ® ; 40% PBS + Alum vaccination). JE-VAX ® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO ® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX ® (64%); as for subjects with serious AEs (1% IXIARO ® ; 2% PBS + Alum vaccination, 1% JE-VAX ® ). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO ® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX ® .

  • long term immunity and immune response to a booster dose following vaccination with the inactivated Japanese Encephalitis Vaccine ixiaro ic51
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Susanne Eder, Elisabeth Schuller, Erich Tauber, Vera Buerger, Gabriele Gartnerwoelfl, Christoph Klade
    Abstract:

    Abstract IC51 (IXIARO ® , JESPECT ® ) is a recently approved prophylactic Japanese Encephalitis virus Vaccine with a two-Vaccine primary immunization regimen. In this phase 3 trial, after primary immunization with a Day 0/28 dose schedule, seroprotection rates were 83%, 58% and 48% at Month 6, Month 12 and Month 24, respectively. A booster dose at Month 11 and/or Month 23 in subjects with neutralizing antibody titers below the limit of detection (defined as a serum dilution giving a 50% reduction of plaque counts in a plaque reduction neutralization test [PRNT50]

  • long term immunity and immune response to a booster dose following vaccination with the inactivated Japanese Encephalitis Vaccine ixiaro ic51
    Vaccine, 2010
    Co-Authors: Katrin Dubischarkastner, Astrid Kaltenboeck, Susanne Eder, Elisabeth Schuller, Erich Tauber, Vera Buerger, Gabriele Gartnerwoelfl, Christoph Klade
    Abstract:

    IC51 (IXIARO, JESPECT) is a recently approved prophylactic Japanese Encephalitis virus Vaccine with a two-Vaccine primary immunization regimen. In this phase 3 trial, after primary immunization with a Day 0/28 dose schedule, seroprotection rates were 83%, 58% and 48% at Month 6, Month 12 and Month 24, respectively. A booster dose at Month 11 and/or Month 23 in subjects with neutralizing antibody titers below the limit of detection (defined as a serum dilution giving a 50% reduction of plaque counts in a plaque reduction neutralization test [PRNT50]<1:10) led to 100% seroconversion. After a single-dose immunization (incomplete primary immunization), only 9% of subjects were seroprotected at Month 6; however, a booster dose at Month 11 led to seroconversion in 99% of subjects. Hence, subjects with incomplete primary immunization can complete their schedule within at least 11 months.

Shigeharu Ueda - One of the best experts on this subject based on the ideXlab platform.

  • safety and immunogenicity of a freeze dried cell culture derived Japanese Encephalitis Vaccine inactivated jebik v in children
    Vaccine, 2012
    Co-Authors: Kenji Okada, Masateru Akechi, Junko Namazue, Toshiaki Iwasa, Shigeharu Ueda
    Abstract:

    Abstract Freeze dried, cell culture-derived Japanese Encephalitis Vaccine (Inactivated) (JEBIK ® V) is approved for a three-dose primary immunization followed by a one-dose booster immunization in Japan. We conducted a multicenter, double-blinded, randomized controlled trial of the safety and immunogenicity of the Vaccine in 370 healthy children who received three doses of 5, 2.5 or 1.25 μg of virus protein per 0.5 mL formulation subcutaneously. Children received two doses of test Vaccine 7–28 days apart followed by a dose 6–12 months after the second vaccination. The three-dose regimen showed a good safety profile with no serious Vaccine-related adverse events. Fever and reactions at the injection site were common adverse reactions at each dose of Vaccine. The seroconversion rates were 100%, 99.2% and 95.0% after two doses in the 5, 2.5 and 1.25 μg groups, respectively, and 100.0% after three doses in all groups. The geometric mean titers were high for all three formulations after the second and third doses, with a very clear dose–response relationship. These results indicate that JEBIK ® V is likely to be a useful Vaccine.

  • Superior immunogenicity of a freeze-dried, cell culture-derived Japanese Encephalitis Vaccine (inactivated).
    Vaccine, 2012
    Co-Authors: Akiko Kikukawa, Yasuyuki Gomi, Masateru Akechi, Toshiyuki Onishi, Sadao Manabe, Junko Namazue, Isao Fuke, Toyokazu Ishikawa, Yoshinobu Okuno, Shigeharu Ueda
    Abstract:

    Abstract Japanese Encephalitis is an infectious disease caused by the Japanese Encephalitis virus, which is widespread throughout Asia. The worldwide incidence is 50,000 cases per year. There is no specific treatment available, but inactivated mouse brain-derived Vaccine was used from the 1950s to prevent infection. However, quality control of mouse brain-derived Vaccines is difficult, and therefore a new freeze-dried, cell culture-derived Japanese Encephalitis Vaccine (inactivated) (JEBIK V; development code: BK-VJE) was developed. In this paper, we report an analysis of neutralizing antibody titers in vaccinated subjects enrolled in clinical study of BK-VJE at various doses, and study of BK-VJE with the mouse brain-derived Vaccine as a control. The results show that BK-VJE has superior immunogenicity compared to mouse brain-derived Vaccine.

Theodore F Tsai - One of the best experts on this subject based on the ideXlab platform.

  • expert opinion on vaccination of travelers against Japanese Encephalitis
    Journal of Travel Medicine, 2009
    Co-Authors: Gerd D Burchard, Tomas Jelinek, Bradley A. Connor, Theodore F Tsai, Eric Caumes, David O Freedman, Elaine C Jong, Frank Von Sonnenburg, Robert Steffen, Annelies Wildersmith
    Abstract:

    Burchard and colleagues 1recommend a new Japanese Encephalitis Vaccine (Ixiaro) for any individual with a travel itinerary that includes a rural area in Asia. They also present an array of medical indications for the Vaccine applicable to urban travelers. Since no duration or season is specified, their recommendations effectively encompass the great majority …

  • primary and booster immune responses to sa14 14 2 Japanese Encephalitis Vaccine in korean infants
    Vaccine, 1999
    Co-Authors: Young Mo Sohn, Robert E Shope, Min Soo Park, Hye Ok Rho, Laura J Chandler, Theodore F Tsai
    Abstract:

    Attenuated SA14-14-2 Japanese Encephalitis (JE) Vaccine has been administered safely and effectively to more than 100 million children in China since 1988 and recently, licensure of the Vaccine in Korea has been sought. In the first clinical evaluation of the Vaccine outside of China, we monitored side effects in 84 children and evaluated antibody responses to a single dose given as primary JE vaccination in 68 children, 1-3 years old (mean age 27 months). No significant adverse events were noted. Neutralizing antibodies (geometric mean titer [GMT] of 188) were produced in 96% of the 68 subjects. In 10 other children who previously had been immunized with two or three doses of inactivated JE Vaccine, the booster administration of SA14-14-2 Vaccine produced an anamnestic response in all, with a GMT of 3378. In a comparison group of 25 children previously immunized with two doses of inactivated Vaccine, neutralizing antibody titers were detected in 16 (64%). Viral specific IgM was detected in nine primary Vaccinees (13%) but in others, IgM may have declined to undetectable levels in the four week postimmunization sample. Live attenuated SA14-14-2 JE Vaccine is a promising alternative to the only commercially available JE Vaccine for national childhood immunization programs in Asia.

  • immunogenicity of live attenuated sa14 14 2 Japanese Encephalitis Vaccine a comparison of 1 and 3 month immunization schedules
    The Journal of Infectious Diseases, 1998
    Co-Authors: Theodore F Tsai, Yu Yongxin, Ravithat Putvatana, Zhang Ran, Wang Shougui, Scott B Halstead
    Abstract:

    Live attenuated SA14-14-2 Japanese Encephalitis (JE) Vaccine has been safe and effective in >100 million immunized children, but its current administration schedule of two doses given a year apart does not lend itself to inclusion in established Expanded Program of Immunization (EPI) schedules of childhood immunization. Immune responses to immunization at shorter intervals were compared in middle-school-aged children immunized with two doses separated by 1 month (n = 116) or 2.5 months (n = 115). Two Vaccine lots were compared. Seroconversion to the Vaccine was observed in 100% of Vaccinees immunized in the 1-month schedule and in 94% (lot 2) and 100% (lot 1) of Vaccinees immunized in the 2.5-month schedule. Geometric mean titers were almost 2-fold higher with the longer schedule. The routine administration of JE SA14-14-2 Vaccine to infants in an EPI schedule should be possible using either interval.

  • short term safety of live attenuated Japanese Encephalitis Vaccine sa14 14 2 results of a randomized trial with 26 239 subjects
    The Journal of Infectious Diseases, 1997
    Co-Authors: Zhengle Liu, Sean Hennessy, Brian L Strom, Warren B Bilker, Theodore F Tsai, Chaomin Wan, Shengcai Tang, Chengfa Xiang, Xiaoping Pan, Yujia Yao
    Abstract:

    The short-term safety of an effective and inexpensive new live attenuated Japanese Encephalitis Vaccine (SA14-14-2) was studied in a randomized trial, using block randomization. Of 26,239 children who were enrolled, half received the Vaccine and half served as controls. Subjects were prospectively followed for 30 days for severe adverse events, such as Encephalitis, meningitis, and all-cause hospitalization. No cases of Encephalitis or meningitis occurred in either group. The upper 95% confidence limit for adverse events not occurring among subjects receiving their first dose was 4.1/ 10,000. Risk ratios and 95% confidence intervals for other adverse events were 0.70 (0.43-1.15) for all-cause hospitalization, 0.91 (0.37-2.22) for seizure, and 0.79 (0.56-1.11) for fever lasting ≥3 days. These data attest to the short-term safety of the SA14-14-2 virus strain and the hamster kidney cell substrate.

  • effectiveness of live attenuated Japanese Encephalitis Vaccine sa14 14 2 a case control study
    The Lancet, 1996
    Co-Authors: Sean Hennessy, Brian L Strom, Warren B Bilker, L Zhengle, W Chaomin, L Huilian, W Taixiang, Y Hongji, L Qimau, Theodore F Tsai
    Abstract:

    Abstract Summary Background Japanese Encephalitis is a major cause of death and disability throughout Asia, including the Indian subcontinent. Although an effective Vaccine for Japanese Encephalitis is available, hundreds of millions of susceptible individuals remain unimmunised because of the Vaccine's cost. In 1988, an inexpensive live-attenuated Vaccine (SA14-14-2) was licensed in China. We have measured the effectiveness of this Vaccine. Methods In a case-control study in rural Sichuan Province, China, the 56 cases consisted of children admitted to hospital with acute Japanese Encephalitis, and were confirmed serologically. 1299 village-matched and age-matched controls were identified, and vaccination histories obtained from pre-existing written records. Findings The effectiveness of one dose was 80% (95% Cl 44 to 93%); that of two doses was 97·5% (86 to 99·6%). Controlling for multiple potential confounders did not alter these results. Interpretation We conclude that a regimen of two doses of live-attenuated Japanese Encephalitis Vaccine, administered 1 year apart, is effective in the prevention of clinically important disease. Subsequent study is needed to assure the safety of this Vaccine.