sábado, 16 de noviembre de 2013

CDC - ACIP - Grading of Recs for Inactivated Japanese Encephalitis Vaccine in Children - Vaccines

full-text ►
CDC - ACIP - Grading of Recs for Inactivated Japanese Encephalitis Vaccine in Children - Vaccines

Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) for Use of Inactivated Vero Cell Culture-derived Japanese Encephalitis Vaccine in Children

Printer friendly version of this page Adobe PDF file [36 pages]

Background

Inactivated Vero cell culture-derived Japanese encephalitis vaccine (JE-VC [manufactured as IXIARO]) is the only JE vaccine licensed and available in the United States.  JE-VC is manufactured by Intercell Biomedical (Livingston, United Kingdom) and distributed in the United States private market by Novartis Vaccines (Cambridge, Massachusetts).  In March 2009, FDA licensed JE-VC for use in adults aged ≥ 17 years.  ACIP recommendations for use of JE-VC in adults were approved in June 2009 and booster dose recommendations were approved in February 2011 [CDC 2010; CDC 2011].
There are no efficacy data for JE-VC.  However, a JE virus 50% plaque reduction neutralization test (PRNT50) titer of ≥ 10 is an established immunologic correlate of protection [Markoff 2000; Hombach 2005].  JE-VC was licensed based on its ability to induce neutralizing antibodies and a non-inferiority comparison to a licensed inactivated mouse brain-derived JE vaccine (JE-MB [manufactured as JE-VAX]). Since JE-VC was licensed in 2009, > 375,000 doses have been distributed in the United States for use in adults.
In May 2013, FDA approved JE-VC for use in children aged 2 months through 16 years [FDA 2013].  The FDA-approved primary series for JE-VC is two intramuscular doses administered 28 days apart.  For children aged 2 months through 2 years each dose is 0.25mL and for adults and children aged ≥3 years each dose is 0.5mL.
The ACIP JE Vaccine Workgroup evaluated the evidence for use of JE-VC in children using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methods [Ahmed 2011]. The workgroup developed a policy question, identified outcomes of critical importance, performed a systematic review of the available data, and evaluated evidence of benefits, harms, values, and preferences for use of JE vaccine in U.S. children.

Policy question

The primary policy question was “Should inactivated Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) be recommended for use in children 2 months through 16 years of age at increased risk of travel-related exposure to Japanese encephalitis virus?”
  • Population:  Children 2 months through 16 years of age traveling to JE-endemic areas
  • Intervention:  JE-VC administered as a 2-dose primary series
  • Current option:  No JE vaccine recommended and available for use in children

Identify and rank relative importance of outcome measures

For the GRADE evaluation of JE-VC in children, the benefits considered critical outcomes for which there were data available included seroprotection at 1 and 6 months after vaccination using the established immunologic correlate of protection (JE virus neutralizing antibodies at a PRNT50 titer ≥10) (Table 1). The harms considered critical outcomes were serious adverse events and systemic adverse events (i.e., fever, rash, hypersensitivity or urticaria, neurologic, and medically attended adverse events). Evidence type for each critical outcome was derived through a review of study design, risk of bias, inconsistency, indirectness, imprecision, and other considerations (i.e., publication bias, strength of association, dose response, or opposing plausible residual confounding).

References

  1. Ahmed F, Temte J, Campos-Outcalt D, Schunemann H, ACIP Evidence Based Recommendations Work Group. Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine 2011;29:9171-6.
  2. Biological E. Unpublished data presented to the ACIP JE Vaccine Workgroup by Katrin Dubischar-Kastner (Intercell AG). April 2013.
    1. Summary:  Randomized, controlled, open-label study in India in which adults aged 18–49 years received two 0.5mL doses of Intercell JE-VC (N=54) or two 0.5mL doses of JEEV (N=108). The seroprotection rate in JEEV recipients was non-inferior to that in JE-VC recipients.  Of note, 91% (49/54) of JE-VC recipients and 86% (93/108) of JEEV recipients were seroprotected at baseline prior to vaccination; 65% (35/54) of JE-VC recipients and 54% (58/108) of JEEV recipients had a ≥4-fold rise in neutralizing antibody titers.
    2. Summary:  Randomized, controlled, open-label study in India in which children aged 1-2 years received two 0.25mL doses of JEEV (N=304) or three doses of JenceVac (N=152).  The seroprotection rate in JEEV recipients was non-inferior to that in JenceVac recipients.
  3. Central Drugs Standard Control Organization. Product approval information [package insert]. JEEV (Japanese encephalitis purified inactivated vaccine-adsorbed) Adobe PDF file [2 pages]External Web Site Icon. Biological E Limited, Hyderabad, India. Accessed May 7, 2013.
    1. Summary:  JEEV is approved in India for use in children aged 1–2 years (two 0.25mL doses administered 28 days apart) and adults aged 18-49 (two 0.5mL doses administered 28 days apart).
  4. CDC. Japanese encephalitis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2010;59 (No. RR-1).
  5. CDC. Recommendations for Use of a Booster Dose of Inactivated Vero Cell Culture-Derived Japanese Encephalitis Vaccine — Advisory Committee on Immunization Practices, 2011. MMWR 2011;60:661-3.
  6. Dubischar-Kastner K, Eder S, Buerger V, et al. Long-term immunity and immune response to a booster dose following vaccination with the inactivated Japanese encephalitis vaccine IXIARO, IC51. Vaccine 2010;28:5197-202.
    1. Summary:  Open-label, uncontrolled study in which adults (≥18 years) enrolled in a previous randomized controlled trial were followed for up to 24 months after receiving two 0.5mL doses of JE-VC (N=116).
  7. Dubischar-Kastner K, Kaltenboeck A, Klingler A, Jilma B, Schuller E.  Safety analysis of a Vero-cell culture derived Japanese encephalitis vaccine, IXIARO® (IC51), in 6 months of follow-up. Vaccine 2010;28:6463-9.
    1. Summary:  Combined safety data from seven clinical trials in which adults (≥18 years) received at least one dose of JE-VC (N=3558), JE-VAX (N=435), or phosphate buffered saline with 0.1% aluminum hydroxide (N=657). The evaluation includes subjects who received JE-VC in alternative doses or schedules or as a booster dose after the 2-dose primary series.
  8. Dubischar-Kastner K.  Pediatric data for IXIARO®: Japanese encephalitis vaccine, inactivated, adsorbed Adobe PDF file [34 pages]. Presentation to the Advisory Committee on Immunization Practices (ACIP), June 19, 2013, Atlanta, GA. Accessed July 19, 2013.
    1. Summary:  Randomized, controlled, open-label study in which children aged 2–11 months received two 0.25mL doses of JE-VC (N=131) or 7-valent pneumococcal conjugate vaccine (Prevnar 7) manufactured by Wyeth  (N=64), and children aged 1-17 years received two 0.25mL doses of JE-VC (N=740), two 0.5mL doses of JE-VC (N=540), or hepatitis A vaccine (Havrix) manufactured by GSK (N=394).  Immunogenicity data were collected only for a subset of 485 children who received JE-VC.
    2. Summary:  Single arm, open-label, dose-range study in which all children aged 2 months through 2 years received two 0.25mL doses of JE-VC (N=5) and all children aged 3-17 years received two 0.5mL doses of JE-VC (N=55).
  9. Erra EO, Hervius Askling H, Rombo L, et al. A single dose of Vero cell-derived Japanese encephalitis (JE) vaccine (IXIARO) effectively boosts immunity in travelers primed with mouse brain-derived JE vaccines. Clin Infect Dis 2012;55(6):825-34.
    1. Summary:  Open-label study in which adults (≥18 years) received two 0.5mL doses of JE-VC (N=31), three doses of JenceVac (N=15), one 0.5mL dose of JE-VC (N=42), or one dose of JenceVac (N=32). Groups were assigned based on previous history of vaccination with JenceVac and availability of vaccine. For this evaluation, immunogenicity data was only included for subjects who received the licensed regimens of two doses of JE-VC or three doses of JenceVac.
  10. Fischer M. Japanese encephalitis (JE) vaccine for U.S. travelers Adobe PDF file [2.9 MB, 42 pages]. Presentation to the Advisory Committee on Immunization Practices (ACIP), February 20, 2013, Atlanta, GA. Accessed July 19, 2013.
  11. Food and Drug Administration. Product approval information [package insert]. Ixiaro (Japanese encephalitis virus vaccine inactivated) Adobe PDF file [25 pages]External Web Site Icon. Intercell Biomedical, Livingston, United Kingdom. Accessed July 17, 2013.
    1. Summary:  FDA-approved primary series for inactivated Vero cell culture-derived JE vaccine (JE-VC; IXIARO) is two 0.25mL doses administered 28 days apart for children aged 2 months through 2 years and two 0.5mL doses administered 28 days apart for adults and children aged ≥3 years.
  12. Food and Drug Administration. Clinical Review - IXIARO Adobe PDF file [68 pges]External Web Site Icon. Accessed July 17, 2013.
  13. Food and Drug Administration. CFR - Code of Federal Regulations 21CFR312.32External Web Site Icon. Accessed May 7, 2013.
  14. Hombach J, Solomon T, Kurane I, Jacobson J, Wood D. Report on a WHO consultation on immunological endpoints for evaluation of new Japanese encephalitis vaccines, WHO, Geneva, 2-3 September, 2004. Vaccine 2005;23:5205-11.
  15. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Glossary 1.50External Web Site Icon. Accessed May 10, 2013.
  16. Kaltenböck A, Dubischar-Kastner K, Eder G, et al.  Safety and immuno­genicity of concomitant vaccination with the cell-culture based Japanese encephalitis vaccine IC51 and the hepatitis vaccine HAVRIX1440 in healthy subjects—a single-blind, randomized, controlled phase 3 study. Vaccine 2009;27:4483-9.
    1. Summary:  Randomized, controlled, observer-blinded study in which adults (≥18 years) received two 0.5mL doses of JE-VC (N=65), two 0.5mL doses of JE-VC and one dose of Havrix (N=62), or one dose of Havrix (N=65).  JE virus immunogenicity data were only collected for adults who received JE-VC with or without Havrix. The seroprotection rate in subjects who received JE-VC and Havrix co-administered was non-inferior to JE-VC alone.  For this evaluation, these two groups were combined.
  17. Kaltenböck A, Dubischar-Kastner K, Schuller E, Datla M, Klade CS, Kishore TS. Immunogenicity and safety of IXIARO (IC51) in a phase II study in healthy Indian children between 1 and 3 years of age. Vaccine 2010;28:834-9.
    1. Summary:  Randomized, controlled, open-label study in which children aged 1-2 years received two 0.25mL doses of JE-VC, two 0.5mL doses of JE-VC, or three doses of JenceVac.
  18. Lyons A, Kanesa-thasan N, Kuschner RA, et al. A Phase 2 study of a purified, inactivated virus vaccine to prevent Japanese encephalitis. Vaccine 2007;25:3445-53.
    1. Summary:  Randomized, controlled, open-label dose ranging study in which adults (18-49 years) received two 0.5mL doses of JE-VC (N=24), three 0.5mL dose of JE-VC (N=24), two 1.0mL doses of JE-VC (N=25), or three doses of JE-VAX (N=21).  For this evaluation, immunogenicity and safety data were included only for subjects who received the licensed regimen of two 0.5mL doses of JE-VC or three doses of JE-VAX.
  19. Markoff L. Points to consider in the development of a surrogate for efficacy of novel Japanese encephalitis virus vaccines. Vaccine 2000;18 Suppl 2:26-32.
  20. Prosser LA, Ray GT, O’Brien M, et al. Preferences and willingness to pay for health states prevented by pneumococcal conjugate vaccine. Pediatrics 2004;113(2):283-90.
  21. Schuller E, Jilma B, Voicu V, et al. Long-term immunogenicity of the new Vero cell-derived, inactivated Japanese encephalitis virus vaccine IC51 Six and 12 month results of a multicenter follow-up phase 3 study. Vaccine 2008;26:4382-6.
    1. Summary:  Open-label follow-up study in which adults (≥18 years) enrolled in a previous randomized controlled trial were followed for up to 12 months after receiving two 0.5mL doses of JE-VC (N=181) or three doses of JE-VAX (N=82).
  22. Schuller E, Klade CS, Wolfl G, Kaltenbock A, Dewasthaly S, Tauber E. 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;27:2188-93.
    1. Summary:  Randomized, controlled, observer-blinded, dose-range study in which adults (≥18 years) received two 0.5mL doses of JE-VC (N=125), one 0.5mL dose of JE-VC (N=124), or one 1.0mL dose of JE-VC (N=124). For this evaluation, immunogenicity and safety data were included only for subjects who received the licensed regimen of two 0.5mL doses of JE-VC.
  23. Schuller E, Klingler A, Dubischar-Kastner K, Dewasthaly S, Müller Z. Safety profile of the Vero cell-derived Japanese encephalitis virus (JEV) vaccine IXIARO. Vaccine 2011;29:8669-76.
    1. Summary:  Inactivated Vero cell culture-derived JE vaccine (JE-VC; IXIARO) was licensed in the United States, Europe, and Australia in 2009 for use in adults. Adverse events following vaccination with JE-VC reported to Intercell AG and retrieved from literature searches, VAERS, and domestic pharmacovigilance network searches from April 2009 through March 2010. The 246,687 doses distributed during this time includes 137,898 in Europe, 85,583 in the United States, and 23,206 in Australia.
  24. Tauber E, Kollaritsch H, Korinek M, et al. Safety and immunogenic­ity of a Vero-cell-derived, inactivated Japanese encephalitis vaccine: a non-inferiority, phase III, randomised controlled trial. Lancet 2007;370:1847-53.
    1. Summary:  Randomized, controlled, observer-blinded, non-inferiority study in which adults (≥18 years) received two 0.5mL doses of JE-VC (N=428) or three doses of JE-VAX (N=435).  The seroprotection rate in JE-VC recipients was non-inferior to that in JE-VAX recipients.
  25. Tauber E, Kollaritsch H, von Sonnenburg F, et al. Randomized, double-blind, placebo-controlled phase 3 trial of the safety and tolerability of IC51, an Inactivated Japanese encephalitis vaccine. J Infect Dis 2008;198:493-9.
    1. Summary:  Randomized, placebo-controlled, double-blinded study in which adults (≥18 years) received two 0.5mL doses of JE-VC (N=1,993) or two doses of phosphate buffered saline with 0.1% aluminum hydroxide (N=657).
  26. VAERS. Unpublished data presented to the ACIP JE Vaccine Workgroup by Ingrid Rabe (CDC). April 2013.
    1. Summary:  Unpublished data of reports of adverse events received by the Vaccine Adverse Events Reporting System (VAERS) as of May 1, 2013 following immunization with JE-VC administered to persons aged ≥ 17 years over the three years from May 1, 2009 to April 30, 2012, in the United States or among U.S. military personnel stationed abroad. Novartis Vaccines (Cambridge, Massachusetts) provided the estimated 275,848 doses distributed in the United States during this time period.  Serious adverse events, hypersensitivity reactions, and neurologic adverse events were actively investigated. Adverse events reported through VAERS and other similar passive surveillance systems may or may not be causally related to the vaccine.
  27. Woolpert T, Staples JE, Faix DJ, et al. Immunogenicity of one dose of Vero cell culture-derived Japanese encephalitis (JE) vaccine in adults previously vaccinated with mouse brain-derived JE vaccine. Vaccine 2012;30:3090-6.
    1. Summary:  Open-label study in the United States in which adults (≥18 years) received two 0.5mL doses of JE-VC (N=123) to evaluate non-inferiority of one dose of JE-VC in previous JE-VAX recipients compared to two doses of JE-VC in previously unvaccinated subjects.  Groups were assigned based on previous history of vaccination with JE-VAX.  The seroprotection rate in previous JE-VAX recipients was non-inferior to previously unvaccinated.  For this evaluation, immunogenicityand safety data were combined for both groups following two doses of JE-VC.

No hay comentarios:

Publicar un comentario